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FDA approves Merck’s KEYTRUDA® (pembrolizumab) as adjuvant treatment for adult and pediatric (≥12 years of age) patients with stage IIB or IIC melanoma following complete resection

KEYTRUDA Is the First Anti-PD-1/L1 Therapy to Show Recurrence-Free Survival Benefit in the Adjuvant Setting for Stage IIB and IIC Melanoma

 

KEYTRUDA Is Now Approved as Adjuvant Treatment for Patients (≥12 Years of Age) With Completely Resected Melanoma Across Stage IIB, Stage IIC and Stage III Disease

 

KENILWORTH, N.J. — (BUSINESS WIRE) — $MRK #MRK–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage IIB or IIC melanoma following complete resection. Additionally, the FDA expanded the indication for KEYTRUDA as adjuvant treatment for stage III melanoma following complete resection to include pediatric patients (12 years and older).

The approval in stage IIB and IIC melanoma is based on data from the first interim analysis of the Phase 3 KEYNOTE-716 trial, in which KEYTRUDA showed a statistically significant improvement in recurrence-free survival (RFS), reducing the risk of disease recurrence or death by 35% (HR=0.65 [95% CI, 0.46-0.92]; p=0.0132) compared to placebo. Median RFS was not reached for either group. After a median follow-up of 14.4 months, 11% (n=54/487) of patients who received KEYTRUDA had recurrence or died compared to 17% (n=82/489) of patients who received placebo. Efficacy in pediatric patients (12 years and older) with stage IIB, IIC and III melanoma is supported by extrapolation of efficacy data from adults, given similar biology, pharmacology of drug effect, as well as similar exposure-response for efficacy and safety.

 

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue and can affect more than one body system simultaneously. Immune-mediated adverse reactions can occur at any time during or after treatment with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions. Early identification and management of immune-mediated adverse reactions are essential to ensure safe use of KEYTRUDA. Based on the severity of the adverse reaction, KEYTRUDA should be withheld or permanently discontinued and corticosteroids administered if appropriate. KEYTRUDA can also cause severe or life-threatening infusion-related reactions. Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. For more information, see “Selected Important Safety Information” below.

 

“The standard of care for patients with resected stage IIB and IIC melanoma has been observation, despite the fact that for these patients, the risk of recurrence is nearly the same as for patients with later-stage disease for whom treatment is recommended,” said Dr. Jason Luke, director, Cancer Immunotherapeutics Center at UPMC Hillman Cancer Center. “Today’s approval of pembrolizumab for the adjuvant treatment of patients 12 years and older with stage IIB and IIC melanoma following complete resection is an important advance that provides these patients with a new option that can help reduce the risk of their cancer returning.”

 

“KEYTRUDA was the first anti-PD-1 therapy to be approved in metastatic melanoma in the U.S. seven years ago. Since then, we have built on this foundation in melanoma and have expanded the use of KEYTRUDA into earlier stages of this disease,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “With today’s approval, we can now offer healthcare providers and patients 12 years and older the opportunity to help prevent melanoma recurrence with KEYTRUDA across resected stage IIB, stage IIC and stage III melanoma.”

 

Study Design and Additional Data From KEYNOTE-716

KEYNOTE-716 (ClinicalTrials.gov, NCT03553836) is a multicenter, randomized (1:1), double-blind, placebo-controlled Phase 3 trial that enrolled 976 patients with completely resected stage IIB or IIC melanoma. Patients were randomized to KEYTRUDA 200 mg or the pediatric (≥12 years old) dose of KEYTRUDA 2 mg/kg intravenously (up to a maximum of 200 mg) every three weeks or placebo for up to one year until disease recurrence or unacceptable toxicity. Randomization was stratified by AJCC eighth edition T Stage (>2.0-4.0 mm with ulceration vs. >4.0 mm without ulceration vs. >4.0 mm with ulceration). Patients must not have been previously treated for melanoma beyond complete surgical resection for their melanoma prior to study entry. The main efficacy outcome measure was investigator-assessed RFS (defined as the time between the date of randomization and the date of first recurrence [local, in-transit or regional lymph nodes or distant recurrence] or death, whichever occurred first). New primary melanomas were excluded from the definition of RFS. Patients underwent imaging every six months for one year from randomization, every six months from years two to four, and then once in year five from randomization or until recurrence, whichever came first.

 

Adverse reactions occurring in patients with stage IIB or IIC melanoma were similar to those occurring in 1,011 patients with stage III melanoma from KEYNOTE-054 or the 2,799 patients with melanoma or NSCLC treated with KEYTRUDA as a single agent. For more information, see “Selected Important Safety Information” below.

 

About Merck in Melanoma

Melanoma, the most serious form of skin cancer, is characterized by the uncontrolled growth of pigment-producing cells. The rates of melanoma have been rising over the past few decades, with nearly 325,000 new cases diagnosed worldwide in 2020. In the U.S., skin cancer is one of the most common types of cancer diagnosed, and melanoma accounts for a large majority of skin cancer deaths. It is estimated there will be more than 106,000 new cases of melanoma diagnosed and more than 7,000 deaths resulting from the disease in the U.S. in 2021.

 

The recurrence rates for resected melanoma are estimated to be 32-46% for patients with stage IIB and stage IIC disease and 39-74% for patients with stage III disease. The five-year survival rates (AJCC eighth edition) are estimated to be 87% for stage IIB, 82% for stage IIC, 93% for stage IIIA, 83% for stage IIIB, 69% for stage IIIC and 32% for stage IIID.

 

Merck is committed to delivering meaningful advances for patients with melanoma with KEYTRUDA and to continuing research in skin cancers through a broad clinical development program. KEYTRUDA has been established as an important treatment option for the adjuvant treatment of adult patients with resected stage III melanoma and is approved in over 90 countries based on the results from EORTC1325/KEYNOTE-054. KEYTRUDA is also approved in over 90 countries for the treatment of patients with unresectable or metastatic melanoma.

 

About Merck’s Early-Stage Cancer Clinical Program

Finding cancer at an earlier stage may give patients a greater chance of long-term survival. Many cancers are considered most treatable and potentially curable in their earliest stage of disease. Building on the strong understanding of the role of KEYTRUDA in later-stage cancers, Merck is studying KEYTRUDA in earlier disease states, with approximately 20 ongoing registrational studies across multiple types of cancer.

 

About KEYTRUDA® (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

 

Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,600 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

 

Selected KEYTRUDA® (pembrolizumab) Indications in the U.S.

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

 

KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage IIB, IIC, or III melanoma following complete resection.

 

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

 

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

 

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is:

  • stage III where patients are not candidates for surgical resection or definitive chemoradiation, or
  • metastatic.

 

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

 

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

 

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) ≥1] as determined by an FDA-approved test.

 

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.

 

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

 

KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.

 

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

 

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC):

  • who are not eligible for any platinum-containing chemotherapy, or
  • who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

 

Non-muscle Invasive Bladder Cancer

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

 

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options.

 

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

 

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

 

Gastric Cancer

KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.

 

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

 

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or GEJ (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either:

  • in combination with platinum- and fluoropyrimidine-based chemotherapy, or
  • as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS ≥10) as determined by an FDA-approved test.

 

Cervical Cancer

KEYTRUDA, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.

 

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.

 

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

 

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

 

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

 

KEYTRUDA is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

 

Tumor Mutational Burden-High Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

 

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation.

 

Triple-Negative Breast Cancer

KEYTRUDA is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.

 

KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test.

 

Selected Important Safety Information for KEYTRUDA

 

Severe and Fatal Immune-Mediated Adverse Reactions

 

KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the PD-1 or the PD-L1, blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.

 

Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of anti–PD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. For patients with TNBC treated with KEYTRUDA in the neoadjuvant setting, monitor blood cortisol at baseline, prior to surgery, and as clinically indicated. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

 

Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy.

 

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients.

 

Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients. Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). Pneumonitis rates were similar in patients with and without prior thoracic radiation. Pneumonitis led to discontinuation of KEYTRUDA in 5.4% (21) of patients. Of the patients who developed pneumonitis, 42% interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution.

 

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (1.1%), and Grade 2 (0.4%) reactions. Systemic corticosteroids were required in 69% (33/48); additional immunosuppressant therapy was required in 4.2% of patients. Colitis led to permanent discontinuation of KEYTRUDA in 0.5% (15) and withholding in 0.5% (13) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Colitis resolved in 85% of the 48 patients.

 

Hepatotoxicity and Immune-Mediated Hepatitis

KEYTRUDA as a Single Agent

KEYTRUDA can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.4%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 68% (13/19) of patients; additional immunosuppressant therapy was required in 11% of patients. Hepatitis led to permanent discontinuation of KEYTRUDA in 0.2% (6) and withholding in 0.3% (9) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Hepatitis resolved in 79% of the 19 patients.

 

KEYTRUDA With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider monitoring more frequently as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased alanine aminotransferase (ALT) (20%) and increased aspartate aminotransferase (AST) (13%) were seen at a higher frequency compared to KEYTRUDA alone. Fifty-nine percent of the patients with increased ALT received systemic corticosteroids. In patients with ALT ≥3 times upper limit of normal (ULN) (Grades 2-4, n=116), ALT resolved to Grades 0-1 in 94%. Among the 92 patients who were rechallenged with either KEYTRUDA (n=3) or axitinib (n=34) administered as a single agent or with both (n=55), recurrence of ALT ≥3 times ULN was observed in 1 patient receiving KEYTRUDA, 16 patients receiving axitinib, and 24 patients receiving both. All patients with a recurrence of ALT ≥3 ULN subsequently recovered from the event.

 

Immune-Mediated Endocrinopathies

 

Adrenal Insufficiency

KEYTRUDA can cause primary or secondary adrenal insufficiency. For Grade 2 or higher, initiate symptomatic treatment, including hormone replacement as clinically indicated.

Contacts

Media Contacts:

Melissa Moody

(215) 407-3536

Investor Contacts:

Peter Dannenbaum

(908) 740-1037

Read full story here

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Science Technology

Infinity BiologiX confirms robust rRT-PCR test detects Omicron variant of COVID-19

PISCATAWAY, N.J. — (BUSINESS WIRE) — Infinity BiologiX (“IBX”), a leader in analytics, bioprocessing and biobanking, announced that the rRT-PCR assay performed to detected SARS-CoV-2 in samples from individuals suspected of COVID-19 can detect the Omicron variant.

Since May 2021 IBX has tested over 9 million samples for COVID-19 with a robust assay using an rRT-PCR test that has been confirmed to detect the Omicron variant.

 

“We’re proud to be providing robust COVID-19 testing as part of our ongoing support for the US response to the COVID-19 pandemic. The ability to detect the omicron variant using our existing rRT-PCR based assay, which targets 3 separate areas of the viral genome, demonstrates our rigorous approach to testing and our commitment to public health.” Robin Grimwood, CEO at IBX.

 

In addition, IBX has been working with the Centers for Disease Control and Prevention (CDC) to sequence the SARS-CoV-2 genome from positive COVID-19 samples across the United States and in light of the omicron variant this has been extended. The contract “Genomic Surveillance for SARS-COV-2 Variants” aims to provide genomic sequencing and new variant detection of samples of SARS-COV-2 to enable public health officials to investigate the impact of variants on disease severity as well as the effectiveness of vaccines and treatment.

 

As part of this work with the CDC, IBX have sequenced over 61,000 COVID-19 samples and continue to provide valuable epidemiological data on the spread of novel COVID-19 strains. This sequencing has been performed in the IBX headquarters in NJ (Piscataway).

 

About Infinity BiologiX (IBX): IBX is a market-disrupting next-generation central laboratory supporting academia, government, and industry. IBX provides global sample collection, processing, storage, and analytical services integrated with scientific and technical support in both the research and clinical arenas. As a leader in biomaterials, IBX provides support to the development of diagnostics, therapeutics, and research in the genomics, precision, and regenerative medicine arenas. IBX previously operated as RUCDR Infinite Biologics before spinning off from Rutgers University-New Brunswick in August 2020.

 

For more information, please visit www.ibx.bio

Contacts

Mike Thurogood

Mike.thurogood@infinity-biologix.com

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Healthcare Science

Seven and Eight Biopharma’s BDB001 in combination with an anti-PD-L1 mAb shows favorable safety and clinical responses in interim Phase 1 data presented at the 2021 SITC Annual Meeting

EDISON, N.J. — (BUSINESS WIRE) — Seven and Eight Biopharmaceuticals Inc., a clinical stage biotechnology company developing proprietary novel immuno-oncology therapies to activate the immune system against cancer, announces the presentation of interim Phase 1 data for BDB001 in combination with atezolizumab in advanced solid tumors at the 2021 Society for Immunotherapy of Cancer (SITC) Annual Meeting.

BDB001 is an immune modulator capable of activating dendritic cells to initiate both innate and adaptive immunity against cancer. BDB001 is a first-in-class TLR7/8 agonist delivered intravenously, allowing for broader treatment of solid tumors. Previously, Seven and Eight Biopharma reported that intravenous administration of BDB001 both as monotherapy and in combination with an anti-PD-1 mAb exhibit favorable tolerability and robust systemic immune activation leading to durable clinical responses in multiple advanced solid tumor types (SITC, 20201; ASCO, 20212).

 

The presentation at SITC 2021 provides interim safety and efficacy results for a Phase 1 dose escalation / expansion trial of BDB001 in combination with atezolizumab in advanced solid tumors (NCT04196530). The results show that BDB001 in combination with atezolizumab is well tolerated with evidence of robust immune activation leading to clinical responses in multiple tumor types.

 

“It is encouraging to see that BDB001 in combination with atezolizumab can be safely delivered intravenously and produces clinical responses in heavily pre-treated tumors” said lead author and study investigator Dr. Manish R. Patel, of Florida Cancer Specialists/Sarah Cannon Research Institute.

 

“These promising interim results show that BDB001 in combination with atezolizumab represents a novel and viable treatment for advanced solid tumors. It is especially encouraging to see responses in both PD-1 naïve and refractory tumors.” said Dr. Robert H.I. Andtbacka, Chief Medical Officer, Seven and Eight Biopharma. “The Phase 1 trial helped establish the BDB001 phase 2 dose which is being evaluated in an ongoing Phase 2 trial (NCT03915678) of BDB001 in combination with atezolizumab and radiotherapy in selected tumor types.”

 

“We are very excited about the clinical data for BDB001 in combination with atezolizumab, as we continue to advance our robust immuno-oncology pipeline in treatments beyond anti-PD-(L)1, including preclinical platform programs in TLR Ligand Antibody Conjugation” said Dr. Walter Lau, Chief Executive Officer, Seven and Eight Biopharma.

 

Presentation Details:

Abstract Title: BDB001, a Toll-Like Receptor 7 and 8 (TLR7/8) agonist, can be safely administered intravenously in combination with atezolizumab and shows clinical responses in advanced solid tumors.

 

Abstract Authors: Manish R. Patel, Drew W. Rasco, Melissa L Johnson, Anthony W. Tolcher, Angela Tatiana Alistar, David Sommerhalder, Omid Hamid, Lixin Li, Alexander H. Chung, Robert H.I. Andtbacka

 

Session: Poster Presentation

 

On-Demand Session Release Date and Time: November 13th, 2021 @ 7:00 AM

 

Abstract Number: 472

 

The poster presentation will be available at the SITC 2021 Annual Meeting website.

 

Abstract Summary:

 

  • Seven and Eight Biopharma’s systemic delivery of the TLR 7 and 8 dual agonist BDB001 is first in class.
  • BDB001 was delivered safely intravenously in combination with atezolizumab.
  • BDB001 in combination with atezolizumab showed robust dose dependent immune activation without increased risk of cytokine release syndrome.
  • Overall, BDB001 was well tolerated and 31.7% of subjects did not have any treatment related adverse events. No DLTs occurred and there were no Grade 4 or 5 Adverse Events.
  • Clinical responses were seen in subjects with urothelial carcinoma and non-small cell lung cancer and showed evidence of robust anti-tumor immune activation.
  • Clinical responses were seen in tumors that had progressed on anti-PD-1 therapy and with low probability of responding to anti-PD-(L)1 therapy based on their PD-L1 negative, MSI-stable, and Tumor Mutational Burden-low status.
  • A Phase 2 trial has been initiated and is actively enrolling subjects to further investigate BDB001 in combination with atezolizumab and radiotherapy in patients with advanced solid tumors
  • BDB001 in combination with atezolizumab represents a novel and viable therapeutic option for patients with advanced solid tumors.

 

About Seven and Eight Biopharma

Seven and Eight Biopharmaceuticals Inc. is an Edison, New Jersey based, clinical stage biotechnology company focused on the development and commercialization of novel immunotherapies for cancer. The company specializes in TLR7/8 programs to treat cancer and has built a comprehensive global intellectual property portfolio in the category of toll-like receptor modulators. Managed by a seasoned team of professionals, the company is progressing a proprietary pipeline of cancer therapeutics in the U.S., with the lead products BDB001 and BDB018 in Phase 1 and 2 clinical trials in monotherapy and in combination with both anti-PD-1 and anti-PD-L1 monoclonal antibodies.

 

For more information, please visit www.7and8biopharma.com.

 

References

1 J Immunother Cancer 2020;8 (Suppl 3) A324

2 J Clin Oncol 39, 2021 (suppl 15; abstr 2512)

Contacts

Robert Andtbacka, MD, CM

Chief Medical Officer

Seven and Eight Biopharmaceuticals Inc.

+1 (848) 300-0086

info@7and8biopharma.com

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Science Technology

Amneal to virtually participate at upcoming investor conferences

BRIDGEWATER, N.J. — (BUSINESS WIRE) — Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (the “Company”) today announced that its investor relations or management team will virtually attend the following investor conferences:

Jefferies London Healthcare Conference

November 18, 2021

Investor Relations Hosted Meetings

Goldman Sachs Global Sustainability Forum

November 30, 2021

Investor Relations Hosted Meetings

Evercore ISI 4th Annual HEALTHCONx Virtual Conference

December 1, 2021

Management Hosted Meetings

Presentation – 8:25 a.m. Eastern Time

The presentation at the Evercore Conference will begin at 8:25 AM Eastern Time and a live webcast will be accessible through the Investor Relations section of the Company’s website at https://investors.amneal.com. A replay of the webcast will be posted shortly after the call.

 

About Amneal

Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully-integrated pharmaceutical company focused on the development, manufacturing and distribution of generic and specialty drug products. The Company has operations in North America, Asia, and Europe, working together to bring high-quality medicines to patients primarily within the United States.

 

Amneal has an extensive portfolio of approximately 250 product families and is expanding its portfolio to include complex dosage forms, including biosimilars, in a broad range of therapeutic areas. The Company also markets a portfolio of branded pharmaceutical products through its Specialty segment focused principally on central nervous system and endocrine disorders.

 

The Company also owns 65% of AvKARE. AvKARE provides pharmaceuticals, medical and surgical products and services primarily to governmental agencies, primarily focused on serving the Department of Defense and the Department of Veterans Affairs. AvKARE is also a packager and wholesale distributor of pharmaceuticals and vitamins to its retail and institutional customers who are located throughout the United States focused primarily on offering 340b-qualified entities products to provide consistency in care and pricing. For more information, visit www.amneal.com.

Contacts

Tony DiMeo

Senior Director, Investor Relations

Anthony.DiMeo@amneal.com

Categories
Business Science

SigmaLedger’s CuBE, a universal solution for coupons and rewards, adopted by P&G and Walgreens

JERSEY CITY, N.J. — (BUSINESS WIRE) — SigmaLedger, a leading SaaS provider of blockchain-based innovative traceability solutions, announced today that CuBE (Coupon Business Exchange), their solution to address coupon fraud, has been adopted by P&G (Procter & Gamble) and Walgreens.


Coupon fraud costs the retail industry over $100 million each year.1 In addition, retailers must face other consequences such as delayed checkouts, cashier/shopper friction and a lengthy and labor-intensive coupon clearing process. CuBE eliminates coupon fraud, accelerates coupon clearance, and reduces overall processing costs. It is a proactive solution, rejecting fraud at POS (point of sale) in real-time at the first occurrence.

 

“We are proud to bring this innovative solution to the market, addressing an industry-wide problem that negatively impacts manufacturers, retailers, employees and customers,” said Oleksandr Rivkind, CEO of SigmaLedger. “We are grateful to the early adopters of CuBE, who have supported our efforts in fraud prevention.”

 

CuBE utilizes Blockchain technology to secure the data, bring trust and enable further innovation to coupon issuance, clearing and settlement.

 

“We are proud to fund SigmaLedger, via our start-up ecosystem ventures program, and help drive innovation and technology transformations for enterprise CPG/Retail organizations,” said Elaina Shekhter, Chief Strategy Officer of EPAM Systems. “SigmaLedger’s blockchain-based CuBE solution transforms the retail coupon technology landscape by accelerating clearances, improving traceability and vastly reducing fraud.”

 

CuBE connects manufacturers and retailers, allowing coupon validation to be run at POS, rejecting fraudulent coupons, and reporting redemption in real time. It also offers digital clearing which saves money, leads to faster retailer reimbursement, and provides access to transaction-level data.

 

“CuBE has had nearly instant success, virtually eliminating counterfeit coupons with our launch partners,” said Mike Loyson, Brand Director of Value Delivery and Couponing, Procter & Gamble Co. “Beyond the financial benefits of fraud elimination, CuBE quickens and conciliates shopper checkout and delivers an innovation glidepath via a platform that can scale across manufacturers and retailers in weeks.”

 

The adoption of CuBE is growing rapidly among retailers and manufacturers, offering a forward-looking solution, detecting fraud for both paper and digital coupons and finding suspicious patterns, stolen coupons and more. It is currently deployed in over 10,000 US stores and reduced fraud by nearly 90% immediately after deployment.

 

“The integration of CuBE with our existing software was seamless, with no notable reduction in processing speed,” said Heather Vondrasek, Asset Protection, Walgreens. “The adoption of CuBE has equipped our team members with the technology to identify and reject counterfeit coupons, leading to an overall reduction in losses associated with coupon fraud.”

 

If you want to learn more about CuBE, contact us or visit www.cube.sigmaledger.com/

References:

  1. https://www.pennlive.com/life/2017/04/coupon_crime_is_no_joke.html

About SigmaLedger

SigmaLedger is a SaaS provider of blockchain based innovative solutions focusing on counterfeit prevention, supply chain transparency and digital direct marketing. For additional information please contact us at info@sigmaledger.com or visit www.sigmaledger.com.

 

About Walgreens

Walgreens (www.walgreens.com) is included in the United States segment of Walgreens Boots Alliance, Inc. (Nasdaq: WBA), a global leader in retail pharmacy. As America’s most loved pharmacy, health and beauty company, Walgreens purpose is to champion the health and wellbeing of every community in America. Operating more than 9,000 retail locations across America, Puerto Rico and the U.S. Virgin Islands, Walgreens is proud to be a neighborhood health destination serving approximately 8 million customers each day. Walgreens pharmacists play a critical role in the U.S. healthcare system by providing a wide range of pharmacy and healthcare services. To best meet the needs of customers and patients, Walgreens offers a true omnichannel experience, with platforms bringing together physical and digital, supported by the latest technology to deliver high-quality products and services in local communities nationwide.

Contacts

Oleksandr Rivkind

alik.rivkind@sigmaledger.com

Categories
Business Science

Bayer Consumer Health Media Team named AdExchanger winner for Best In-House Media Operations

Team also named Best in Show for Overall Excellence in Programmatic Media Award

 

WHIPPANY, N.J. — (BUSINESS WIRE) — For the second consecutive year, the Bayer Consumer Health Media Team has been selected as the winner in the Best In-House Media Operations category during the 2021 AdExchanger Awards. The team also earned Best In Show for Overall Excellence in Programmatic Media. The AdExchanger Awards celebrate excellence in digital marketing and advertising.

“Our in-house approach harnesses the power and passion of our employees as no one knows our business and brands better than the people who work at Bayer,” said Jeff Rasp, Head of Media, Digital Platforms and Content, Bayer Consumer Health. “As a result, our team is able to move more quickly and efficiently to seamlessly deliver creative and impactful media plans.”

 

Bayer Consumer Health began its journey of in-sourcing digital media strategy and operations in 2018. In 2019, the team was named a finalist by AdExchanger for Best In-House Media Operations.

 

“Our greatest achievement over the last few years has been building a second-to-none team of industry leading experts who work together seamlessly and bring out the best in each other,” said Jeff Jarrett, Chief Marketing Officer, Bayer Consumer Health. “Through their relentless pursuit of excellence, they are driving our business forward with their bold strategies and executions.”

 

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2020, the Group employed around 100,000 people and had sales of 41.4 billion euros. R&D expenses before special items amounted to 4.9 billion euros. For more information, go to www.bayer.us.

 

Bayer® and the Bayer Cross® are registered trademarks of Bayer.

 

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Contacts

Alex Borchard

Bayer U.S. — Consumer Health

Email: alex.borchard@bayer.com
Mobile: 201-274-9429

Social Media Channels

– Facebook: BayerUnitedStates
– Twitter: BayerUS
– Instagram: BayerUS
– YouTube: BayerUS

Categories
Science Technology

Redline Detection unveils EV Battery + Coolant Leak Detector

Launch of Redline EV Technology Center

 

LAS VEGAS — (BUSINESS WIRE) — #EV—Redline Detection, the world’s leader in diagnostic leak detection technology, announced today a new division of the company that has engineered diagnostic leak detection technology exclusively for battery electric vehicles.


Speaking at the SEMA Show in Las Vegas, Redline Detection CMO Alex Parker announced that a major global OEM has made the new Battery + Coolant Leak Detector an essential tool for electric vehicle diagnostics at all dealer locations in 160 countries.

 

“The wide adoption of electric vehicles hinges upon safety and reliability. Redline has partnered with leading EV automakers to develop technology that gives 100% assurance that battery cases and battery coolant systems are sealed under precise pressures and meet all OEM and battery manufacturer warranty standards for safety,” said Parker.

 

The Battery + Coolant Leak Detector (BCLD) was designed to test the integrity of battery enclosures in electric and hybrid vehicles. Durable and compact, BCLD connects to the battery enclosure on or off the vehicle, giving audible and visual progress and precise pass/fail indication—specific to that battery and vehicle type—when testing is complete. Data logging and reports can be accessed remotely and the machine is programmable for future battery configurations.

 

Testing the integrity of battery enclosures is necessary to ensure that there is no possible intrusion of water, dust, or contaminants that could cause catastrophic failure. Battery enclosures are tested after any collision, even a scrape to the bottom of the battery box over a curb that could compromise the seal, as well as after lid off battery maintenance or service. BCLD gives OEMs and aftermarket service locations the ability to do lid off maintenance and repairs, and restore the integrity of battery and battery coolant enclosures to original factory design specifications.

 

Redline has also opened a dedicated EV Technology Center in Orange, CA for ongoing battery testing, research, and technician education. The space can be used for both in-person and virtual technical demonstrations.

 

“The future of automotive technology is evolving quickly and Redline technology is at the forefront of these exciting changes, supporting the engineers and technicians who use our technology to ensure peak performance. Redline is the trusted world’s leader across traditionally aspirated, boosted, and now electric vehicle diagnostic leak detection technology,” said Parker.

 

About Redline Detection

Redline Detection, headquartered in Orange, Calif., develops and manufactures the world’s best-selling diagnostic leak detection equipment. From the world’s leading OEMs to individual technicians, Redline Detection has built a global fan base for its professional grade custom diagnostic solutions, as well as its ability to increase the bottom line. In 2020, Redline Detection was awarded the prestigious title of SEMA Manufacturer of the Year. To learn more about Redline Detection and its award-winning products, please visit www.redlinedetection.com.

Contacts

Julia Morris

jmorris@redlinedetection.com
Redline Detection

+1 714 -451-1411

Categories
Healthcare Science

New Phase 3 data presented at psych Congress 2021 showed TV-46000/mdc-IRM significantly prolonged time to impending relapse compared to placebo in patients with schizophrenia

Phase 3 RISE study evaluated treatment with TV-46000, a subcutaneous long-acting injectable risperidone formulation

New data showed TV-46000 decreased risk of relapse and increased chance of clinical stability versus placebo in patients with schizophrenia

 

TEL AVIV, Israel & PARSIPPANY, N.J. — (BUSINESS WIRE) — Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced results from the pivotal Phase 3 Risperidone Subcutaneous Extended-release (RISE) study comparing TV-46000/mdc-IRM once monthly (q1m) and TV-46000/mdc-IRM once every two months (q2m) with placebo (1:1:1) in patients with schizophrenia who underwent stabilization on oral risperidone. Results showed treatment with TV-46000 (overall, q1m or q2m) significantly prolonged time to relapse, decreased proportions of patients with impending relapse at week 24 and demonstrated significant increase in proportions maintaining stability. The safety profile of TV-46000, as demonstrated in this study, is consistent with other formulations of risperidone. The most common adverse reactions (≥5% and greater than placebo) were nasopharyngitis, increased weight, and extrapyramidal disorder. These findings, among others, were presented during the poster session at the 2021 Psych Congress Annual Meeting taking place Oct. 29-Nov. 1, 2021 in San Antonio, TX (in addition to virtual participation).

Schizophrenia is a chronic and severe mental disorder1 characterized by distortions in thinking, perception, emotions, language, sense of self and behavior.2 Twenty million people worldwide are affected by schizophrenia1, often living with considerable disability.2 Currently, about 70% of people living with schizophrenia are not receiving appropriate care3 despite the treatability of the illness.2

 

“Relapse rates among people living with schizophrenia are quite staggering, ranging between 50 and 92% globally.4,5 It is crucial to provide patients and prescribers with treatment options that have the potential to reduce relapse rates to help manage and stabilize the disease over time,” said Eran Harary, MD, VP Global Head of Specialty R&D at Teva. “Coming off the heels of the recent FDA acceptance of our New Drug Application, we’re proud to be sharing our Phase 3 data at this year’s Psych Congress. We are committed to investigating the full potential of our subcutaneous long-acting injectable (LAI) formulation of risperidone for the treatment of this complex and burdensome illness.”

 

“When managing schizophrenia, it is crucial to have treatment options that work to reduce the risk of relapse. As researchers, physicians and providers, we must work together to address this,” said John Kane, MD, Professor and Chairman, Department of Psychiatry, The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell and RISE lead investigator. “These latest data from the Phase 3 RISE study are quite encouraging for both patients and providers.”

 

Efficacy and Safety of Subcutaneous Risperidone Injectable (TV-46000) in Patients With Schizophrenia: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Relapse Prevention Study (RISE Study)

The Phase 3 RISE study was designed to compare TV-46000 q1m and TV-46000 q2m with placebo (1:1:1 ratio; stage 2) in patients with schizophrenia who underwent stabilization on oral risperidone (stage 1). The primary endpoint was time to impending relapse and secondary endpoints included proportions of patients with impending relapse at week 24 and proportions of patients who maintained stability at week 24. No new safety signals were identified with TV-46000 versus accumulated safety data of oral risperidone and other long-acting risperidone formulations.

 

Out of 1267 patients screened, 863 were enrolled and 544 were randomized. Time to impending relapse significantly favored TV-46000 (hazard ratio [95% CI]; overall: 0.283 [0.184, 0.435], P<.0001; q1m: 0.200 [0.109, 0.367], P<.0001; q2m: 0.375 [0.227, 0.618], P<.0001) versus placebo. TV-46000 also prolonged time to relapse by 3.5, 5.0 and 2.7 times, respectively, versus placebo. Proportions of patients with impending relapse at week 24 were significantly lower for TV‑46000 (overall: 9%; q1m: 7%; q2m: 11%) versus placebo (28%; P<.0001, P<.0001, P=.0001, respectively). Proportions of patients maintaining stability were significantly higher (83%, 87%, 80% vs 61%; P<.0001, P<.0001, P=.0001, respectively). The safety profile of TV-46000, as observed in this study, is consistent with other formulations of risperidone. The most common adverse reactions (≥5% and greater than placebo) were nasopharyngitis, increased weight, and extrapyramidal disorder.

 

About TV46000-CNS-30072 (The RISE Study – The Risperidone Subcutaneous Extended-Release Study)

The RISE study was a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy of risperidone extended-release injectable suspension for subcutaneous use as a treatment in patients (ages 13-65 years) with schizophrenia. 544 patients were randomized to receive a subcutaneous injection of TV-46000 once monthly (q1M), once every two months (q2M), or placebo in a 1:1:1 ratio. The primary endpoint was time to impending relapse.

 

About Schizophrenia

Schizophrenia is a chronic, progressive and severely debilitating mental disorder that affects how one thinks, feels and acts. Patients experience an array of symptoms, which may include delusions, hallucinations, disorganized speech or behavior and impaired cognitive ability. Approximately 1% of the world’s population will develop schizophrenia in their lifetime, and 3.5 million people in the U.S. are currently diagnosed with the condition. Although schizophrenia can occur at any age, the average age of onset tends to be in the late teens to the early 20s for men, and the late 20s to early 30s for women. The long-term course of schizophrenia is marked by episodes of partial or full remission broken by relapses that often occur in the context of psychiatric emergency and require hospitalization. Approximately 80% of patients experience multiple relapses over the first five years of treatment, and each relapse carries a biological risk of loss of function, treatment refractoriness, and changes in brain morphology. Patients are often unaware of their illness and its consequences, contributing to treatment nonadherence, high discontinuation rates, and ultimately, significant direct and indirect healthcare costs from subsequent relapses and hospitalizations.

 

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. Learn more at www.tevapharm.com.

 

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to the development of risperidone LAI; our ability to successfully compete in the marketplace, including our ability to develop and commercialize biopharmaceutical products, competition for our specialty products, including AUSTEDO®, AJOVY® and COPAXONE®; our ability to achieve expected results from investments in our product pipeline, our ability to develop and commercialize additional pharmaceutical products, and the effectiveness of our patents and other measures to protect our intellectual property rights; our substantial indebtedness; our business and operations in general, including uncertainty regarding the COVID-19 pandemic and its impact on our business, financial condition, operations, cash flows, and liquidity and on the economy in general, our ability to successfully execute and maintain the activities and efforts related to the measures we have taken or may take in response to the COVID-19 pandemic and associated costs therewith, costs and delays resulting from the extensive pharmaceutical regulation to which we are subject or delays in governmental processing time due to travel and work restrictions caused by the COVID-19 pandemic; compliance, regulatory and litigation matters, including failure to comply with complex legal and regulatory environments; other financial and economic risks; and other factors discussed in our Annual Report on Form 10-K for the year ended December 31, 2020, including in the section captioned “Risk Factors.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

____________________________

1 GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017. [published correction appears in Lancet. 2019 Jun 22;393 (10910):e44]. Lancet. 2018;392 (10159): 1789-1858.

2 World Health Organization. Schizophrenia. www.who.int/news-room/fact-sheets/detail/schizophrenia. Accessed on October 4, 2021.

3 Lora A, et al. Service availability and utilization and treatment gap for schizophrenic disorders: a survey in 50 low- and middle-income countries. Bulletin of the World Health Organization. 90 (1), 47-54B. World Health Organization. http://dx.doi.org/10.2471/BLT.11.089284
4Cernansky JG, Schuchart EK. Relapse and rehospitalisation rates in patients with schizophrenia: effects of second generation antipsychotics CNS Drugs. 2002;16(7):473–484.

5Weret ZS, Mukherjee R. Prevalence of relapse and associated factors in patient with schizophrenia at Amanuel Mental Specialized Hospital, Addis Ababa, Ethiopia: institution based cross sectional study. International Journal of Interdisciplinary and Multidisciplinary Studies. 2014, Vol 2, No.1, 184-192.

Contacts

IR

United States

Kevin C. Mannix (215) 591-8912

Yael Ashman 972 (3) 914-8262

PR

United States
Yonatan Beker (973) 917-0851

Categories
Local News Science

Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) + chemotherapy for patients with HER2 negative, advanced or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma …

Approval is based on positive results from the Phase 3 CheckMate -649 trial

Opdivo plus chemotherapy is the first treatment regimen to demonstrate superior overall survival and progression-free survival compared to chemotherapy alone in this patient population

 

Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) + Chemotherapy for Patients with HER2 Negative, Advanced or Metastatic Gastric, Gastroesophageal Junction or Esophageal Adenocarcinoma whose Tumors Express PD-L1 with CPS ≥ 5

 

PRINCETON, N.J. — (BUSINESS WIRE) — $BMY #CheckMate —  Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has approved Opdivo (nivolumab) in combination with fluoropyrimidine- and platinum-based combination chemotherapy for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma (EAC) whose tumors express PD-L1 with a combined positive score (CPS) ≥ 5.

The EC’s decision is based on results from the Phase 3 CheckMate -649 trial, in which first-line treatment with Opdivo plus leucovorin, 5-fluorouracil and oxaliplatin (FOLFOX) or capecitabine and oxaliplatin (CapeOX) was compared with chemotherapy alone. Results from the trial showed a statistically significant and clinically meaningful improvement in overall survival (OS) and progression-free survival (PFS) in patients with unresectable advanced or metastatic gastric cancer (GC), GEJ cancer (GEJC) or EAC whose tumors express PD-L1 with a CPS ≥ 5 (the primary endpoints of the study). The statistically significant OS benefit shown with Opdivo plus chemotherapy was also observed in PD-L1 positive patients with CPS ≥ 1 and in the all-randomized population. The safety profile observed for Opdivo plus chemotherapy in the CheckMate -649 trial was consistent with the known safety profiles of the individual treatments.

 

“This approval marks a great achievement for many patients with gastric, gastroesophageal junction and esophageal adenocarcinomas, who now have a new treatment option that has demonstrated superior overall survival compared to the long-standing standard of care,” said Ian M. Waxman, M.D., development lead, gastrointestinal cancers, Bristol Myers Squibb. “With limited advances for HER2-negative gastric cancers made in the past ten years, we are especially pleased to move the field forward and introduce this Opdivo-based combination for patients in the European Union.”

 

The EC approval allows for the use of Opdivo in combination with fluoropyrimidine and platinum-based combination chemotherapy for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric cancer, gastroesophageal junction (GEJ), or esophageal adenocarcinoma (EAC), whose tumors express PD-L1 with a combined positive score (CPS) ≥ 5 in the 27 member states of the European Union, as well as Iceland, Liechtenstein, and Norway.

 

CheckMate -649 Efficacy and Safety Results in Patients with PD-L1 CPS ≥ 5

Results from CheckMate -649 include:

  • OS (minimum follow‑up of 19.4 months): Median OS was 14.4 months in patients receiving Opdivo plus chemotherapy (95% Confidence Interval [CI]: 13.1 to 16.3) compared to 11.1 months (95% CI: 10.0 to 12.1) in patients receiving chemotherapy alone (Hazard Ratio [HR] 0.69; 95% CI: 0.60 to 0.81).
  • PFS (minimum follow‑up of 19.4 months): Median PFS was 8.31 months in patients receiving Opdivo plus chemotherapy (95% CI: 7.03 to 9.26) vs. 6.05 months (95% CI: 5.55 to 6.90) in patients receiving chemotherapy alone (HR = 0.68; 95% CI: 0.59 to 0.79).
  • Safety: The most frequent adverse reactions were peripheral neuropathy (53%), nausea (48%), fatigue (44%), diarrhea (39%), vomiting (31%), decreased appetite (29%), abdominal pain (27%), constipation (25%), musculoskeletal pain (20%), pyrexia (19%), rash (18%), stomatitis (17%), palmar-plantar erythrodysaesthesia syndrome (13%), cough (13%), oedema (including peripheral oedema) (12%), headache (11%), and upper respiratory tract infection (10%).

 

About CheckMate -649

CheckMate -649 is a Phase 3 randomized, multi-center, open-label study evaluating Opdivo plus chemotherapy or the Opdivo plus Yervoy combination compared to chemotherapy alone in patients with previously untreated, non-HER2-positive, advanced or metastatic gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma. Patients in the Opdivo plus chemotherapy arm received Opdivo 360 mg plus capecitabine and oxaliplatin (CapeOX) every three weeks or Opdivo 240 mg plus 5-fluorouracil, leucovorin and oxaliplatin (FOLFOX) every two weeks. Patients in the Opdivo plus Yervoy arm received Opdivo 1 mg/kg plus Yervoy 3 mg/kg every three weeks for four cycles followed by Opdivo 240 mg every two weeks. Patients in the chemotherapy arm received FOLFOX or CapeOX every two or three weeks, respectively. All patients continued treatment for two years or until disease progression, unacceptable toxicity or withdrawal of consent. The primary endpoints of the trial are overall survival (OS) in PD-L1 positive patients with a combined positive score (CPS) ≥ 5 treated with Opdivo plus chemotherapy and PFS, as assessed by Blinded Independent Central Review (BICR), in CPS ≥ 5 patients treated with Opdivo plus chemotherapy compared to chemotherapy alone. Secondary endpoints include OS in CPS ≥ 1 and all randomized patients treated with Opdivo plus chemotherapy as well as OS and time to symptom deterioration (TTSD) in patients treated with Opdivo plus Yervoy compared to chemotherapy alone.

 

About Gastric Cancer

Gastric cancer, also known as stomach cancer, is the fifth most common cancer and the fourth leading cause of cancer death worldwide, with over 1,000,000 new cases and approximately 770,000 deaths in 2020. There are several cancers that can be classified as gastric cancer, including certain types of cancers that form in the gastroesophageal junction, the area of the digestive tract where the esophagus and stomach connect. While GEJ cancer has a lower prevalence than distal gastric cancer, it continues to rise.

 

About Esophageal Cancer

Esophageal cancer is the seventh most common cancer and the sixth leading cause of death from cancer worldwide, with approximately 600,000 new cases and over 540,000 deaths in 2020. The two most common types of esophageal cancer are squamous cell carcinoma and adenocarcinoma, which account for approximately 85% and 15% of all esophageal cancers, respectively, though esophageal tumor histology can vary by region with the highest rate of esophageal adenocarcinoma occurring in North America (65%) and Europe (~40%).

 

Bristol Myers Squibb: Creating a Better Future for People with Cancer

Bristol Myers Squibb is inspired by a single vision — transforming people’s lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine, and through innovative digital platforms, are turning data into insights that sharpen their focus. Deep scientific expertise, cutting-edge capabilities and discovery platforms enable the company to look at cancer from every angle. Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. Because as a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.

 

About Opdivo

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

 

Opdivo’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.

 

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In October 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.

 

About Yervoy

Yervoy is a recombinant, human monoclonal antibody that binds to the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activity. Yervoy binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation, including the activation and proliferation of tumor infiltrating T-effector cells. Inhibition of CTLA-4 signaling can also reduce T-regulatory cell function, which may contribute to a general increase in T-cell responsiveness, including the anti-tumor immune response. On March 25, 2011, the U.S. Food and Drug Administration (FDA) approved Yervoy 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma. Yervoy is approved for unresectable or metastatic melanoma in more than 50 countries. There is a broad, ongoing development program in place for Yervoy spanning multiple tumor types.

 

INDICATIONS

OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of patients with unresectable or metastatic melanoma.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma.

 

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

 

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

 

OPDIVO® (nivolumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.

 

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).

 

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of patients with intermediate or poor risk advanced renal cell carcinoma (RCC).

 

OPDIVO® (nivolumab), in combination with cabozantinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

 

OPDIVO® (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

 

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

 

OPDIVO® (nivolumab) is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.

 

OPDIVO® (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

 

OPDIVO® (nivolumab), as a single agent, is indicated for the adjuvant treatment of patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC.

 

OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

 

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

 

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

 

OPDIVO® (nivolumab) is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

 

OPDIVO® (nivolumab) is indicated for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.

 

OPDIVO® (nivolumab) is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT).

 

OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.

 

IMPORTANT SAFETY INFORMATION

Severe and Fatal Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions listed herein may not include all possible severe and fatal immune-mediated adverse reactions.

 

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. While immune-mediated adverse reactions usually manifest during treatment, they can also occur after discontinuation of OPDIVO or YERVOY. Early identification and management are essential to ensure safe use of OPDIVO and YERVOY. Monitor for signs and symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and periodically during treatment with OPDIVO and before each dose of YERVOY. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

 

Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). In general, if OPDIVO or YERVOY interruption or discontinuation is required, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below.

 

Immune-Mediated Pneumonitis

OPDIVO and YERVOY can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. In patients receiving OPDIVO monotherapy, immune-mediated pneumonitis occurred in 3.1% (61/1994) of patients, including Grade 4 (<0.1%), Grade 3 (0.9%), and Grade 2 (2.1%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated pneumonitis occurred in 7% (31/456) of patients, including Grade 4 (0.2%), Grade 3 (2.0%), and Grade 2 (4.4%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated pneumonitis occurred in 3.9% (26/666) of patients, including Grade 3 (1.4%) and Grade 2 (2.6%). In NSCLC patients receiving OPDIVO 3 mg/kg every 2 weeks with YERVOY 1 mg/kg every 6 weeks, immune-mediated pneumonitis occurred in 9% (50/576) of patients, including Grade 4 (0.5%), Grade 3 (3.5%), and Grade 2 (4.0%). Four patients (0.7%) died due to pneumonitis.

 

In Checkmate 205 and 039, pneumonitis, including interstitial lung disease, occurred in 6.0% (16/266) of patients receiving OPDIVO. Immune-mediated pneumonitis occurred in 4.9% (13/266) of patients receiving OPDIVO, including Grade 3 (n=1) and Grade 2 (n=12).

 

Immune-Mediated Colitis

 

OPDIVO and YERVOY can cause immune-mediated colitis, which may be fatal. A common symptom included in the definition of colitis was diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients, including Grade 3 (1.7%) and Grade 2 (1%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated colitis occurred in 25% (115/456) of patients, including Grade 4 (0.4%), Grade 3 (14%) and Grade 2 (8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated colitis occurred in 9% (60/666) of patients, including Grade 3 (4.4%) and Grade 2 (3.7%).

 

Immune-Mediated Hepatitis and Hepatotoxicity

 

OPDIVO and YERVOY can cause immune-mediated hepatitis. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients, including Grade 4 (0.2%), Grade 3 (1.3%), and Grade 2 (0.4%). In patients receiving OPDIVO 1 mg/ kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated hepatitis occurred in 15% (70/456) of patients, including Grade 4 (2.4%), Grade 3 (11%), and Grade 2 (1.8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated hepatitis occurred in 7% (48/666) of patients, including Grade 4 (1.2%), Grade 3 (4.9%), and Grade 2 (0.4%).

 

OPDIVO in combination with cabozantinib can cause hepatic toxicity with higher frequencies of Grade 3 and 4 ALT and AST elevations compared to OPDIVO alone. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. In patients receiving OPDIVO and cabozantinib, Grades 3 and 4 increased ALT or AST were seen in 11% of patients.

 

Immune-Mediated Endocrinopathies

OPDIVO and YERVOY can cause primary or secondary adrenal insufficiency, immune-mediated hypophysitis, immune-mediated thyroid disorders, and Type 1 diabetes mellitus, which can present with diabetic ketoacidosis. Withhold OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism; initiate hormone replacement as clinically indicated. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism; initiate hormone replacement or medical management as clinically indicated. Monitor patients for hyperglycemia or other signs and symptoms of diabetes; initiate treatment with insulin as clinically indicated.

 

In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994), including Grade 3 (0.4%) and Grade 2 (0.6%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, adrenal insufficiency occurred in 8% (35/456), including Grade 4 (0.2%), Grade 3 (2.4%), and Grade 2 (4.2%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, adrenal insufficiency occurred in 7% (48/666) of patients, including Grade 4 (0.3%), Grade 3 (2.5%), and Grade 2 (4.1%). In patients receiving OPDIVO and cabozantinib, adrenal insufficiency occurred in 4.7% (15/320) of patients, including Grade 3 (2.2%) and Grade 2 (1.9%).

 

In patients receiving OPDIVO monotherapy, hypophysitis occurred in 0.6% (12/1994) of patients, including Grade 3 (0.2%) and Grade 2 (0.3%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, hypophysitis occurred in 9% (42/456), including Grade 3 (2.4%) and Grade 2 (6%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, hypophysitis occurred in 4.4% (29/666) of patients, including Grade 4 (0.3%), Grade 3 (2.4%), and Grade 2 (0.9%).

In patients receiving OPDIVO monotherapy, thyroiditis occurred in 0.6% (12/1994) of patients, including Grade 2 (0.2%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, thyroiditis occurred in 2.

Contacts

Bristol Myers Squibb

Media Inquiries:
Media@BMS.com

Investors:
Tim Power

609-252-7509

timothy.power@bms.com

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908-673-9711

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Business Science

Shionogi to present In Vitro and Real-World Data at IDWeek 2021 demonstrating activity of FETROJA® (cefiderocol) against gram-negative pathogens

OSAKA, Japan & FLORHAM PARK, N.J. — (BUSINESS WIRE) — Shionogi & Co., Ltd. (hereafter “Shionogi”) today announces that 11 abstracts on FETROJA® (cefiderocol) will be shared at IDWeek. The meeting will take place virtually from Sept. 29 – Oct. 3, 2021.

  

“The data presented at IDWeek underscores our commitment to fighting antimicrobial resistance and addressing the challenges in treating carbapenem-resistant Gram-negative bacteria, which are associated with high mortality and unmet need,” said Akira Kato, Ph.D., President and CEO at Shionogi Inc. “We look forward to sharing new real-world data on FETROJA with the infectious disease community at IDWeek.”

 

Presentations will include data from company-sponsored or investigator-initiated studies. Abstracts will be available in the IDWeek Interactive Program and include:

 

  • Poster #789: Susceptibility of Phenotypic Subsets of Pseudomonas aeruginosa isolates of Cefiderocol and Comparator Agents from SIDERO-WT 2014-2019

    Presenter: Sean Nguyen, Pharm.D.

  • Poster #1058: In Vitro and in Vivo Antibacterial Activity of Cefiderocol against Burkholderia spp.

    Presenter: Merime Ota, BSc

  • Poster #1065: Efficacy of Cefiderocol in Experimental Stenotrophomonas maltophilia Pneumonia in Persistently Neutropenic Rabbits

    Presenter: Vidmantas Petraitis, M.D.

  • Poster #1066: In Vitro and in Vivo Antimicrobial Activity of Cefiderocol and Comparators against Achromobacter spp

    Presenter: Ryuichiro Nakai, MSc

  • Poster #1106: Evaluation of Penetration of Cefiderocol into Cerebrospinal Fluid Using a Rat Meningitis Model

    Presenter: Miki Takemura, M.S.

  • Poster #1232: In Vitro Activity of Cefiderocol and Comparator Agents against Molecularly-characterized Carbapenem-resistant Enterobacterales Clinical Isolates Causing Infection in United States Hospitals (2020)

    Presenter: Rodrigo E. Mendes, Ph.D.

  • Poster #1256: Clinical Response by Minimum Inhibitory Concentrations in Carbapenem-Resistant Pseudomonas aeruginosa Infections under Cefiderocol Compassionate Use Program

    Presenter: Michael Satlin, M.D.

  • Poster #1272: Cefiderocol In Vitro Activity against Molecularly characterized Acinetobacter baumannii-calcoaceticus complex and Pseudomonas aeruginosa Clinical Isolates Causing Infection in United States Hospitals (2020)

    Presenter: Rodrigo E. Mendes, Ph.D.

  • Poster #1287: Double Disk Diffusion Study to Evaluate the Synergistic Effect Between Cefiderocol and Ceftazidime-Avibactam Against Cefiderocol-non-susceptible Acinetobacter baumannii

    Presenter: Yoshinori Yamano, Ph.D.

  • Poster #1291: PROVE (Retrospective Cefiderocol Chart Review) Study of Real-World Outcomes and Safety in the Treatment of Patients with Gram-negative Bacterial Infections in the US and Europe

    Presenter: Stephen W. Marcella, M.D., M.P.H.

  • Poster #1308: Activity of Cefiderocol and Comparators against Gram-negative Isolates from US Patients Hospitalized with Pneumonia

    Presenter: Dee Shortridge, Ph.D.

 

For additional information related to FETROJA, please contact Shionogi at medinfo@shionogi.com.

 

About FETROJA® (cefiderocol) for Injection

FETROJA® (cefiderocol) is a cephalosporin antibiotic with a novel mechanism for penetrating the outer cell membrane of Gram-negative pathogens by acting as a siderophore. In addition to entering cells by passive diffusion through porin channels, FETROJA binds to ferric iron and is actively transported into bacterial cells through the outer membrane via the bacterial iron transporters, which function to incorporate this essential nutrient for bacteria. These mechanisms allow FETROJA to achieve high concentrations in the periplasmic space where it can bind to penicillin-binding proteins and inhibit cell wall synthesis in the bacterial cells. FETROJA has also demonstrated in vitro activity against certain bacteria that contain very problematic resistant enzymes such as ESBLs, AmpC, serine- and metallo-carbapenemases. Data from multinational surveillance studies for FETROJA demonstrated potent in vitro activity against a wide spectrum of Gram-negative pathogens including carbapenem-resistant A. baumannii, P. aeruginosa, Enterobacterales, and S. maltophilia. The clinical significance of the in vitro data is unknown. FETROJA has poor in vitro activity against Gram-positive or anaerobic bacteria.

 

Cefiderocol, under the brand name FETCROJA®, is approved by the European Commission for the treatment of infections due to aerobic Gram-negative bacteria in adults 18 years or older with limited treatment options.

 

US INDICATIONS

Fetroja® (cefiderocol) is indicated in patients 18 years of age or older for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Enterobacter cloacae complex.

 

Fetroja is indicated in patients 18 years of age or older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia, caused by the following susceptible Gram-negative microorganisms: Acinetobacter baumannii complex, Escherichia coli, Enterobacter cloacae complex, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Serratia marcescens.

 

USAGE

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Fetroja and other antibacterial drugs, Fetroja should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

 

SELECT IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Fetroja is contraindicated in patients with a known history of severe hypersensitivity to cefiderocol or other beta-lactam antibacterial drugs, or any other component of Fetroja.

 

WARNINGS AND PRECAUTIONS

Increase in All-Cause Mortality in Patients with Carbapenem-Resistant Gram-Negative Bacterial Infections

An increase in all-cause mortality was observed in patients treated with Fetroja as compared to best available therapy (BAT) in a multinational, randomized, open-label trial in critically ill patients with carbapenem-resistant Gram-negative bacterial infections (NCT02714595). Patients with nosocomial pneumonia, bloodstream infections, sepsis, or cUTI were included in the trial. BAT regimens varied according to local practices and consisted of 1 to 3 antibacterial drugs with activity against Gram-negative bacteria. Most of the BAT regimens contained colistin.

 

The increase in all-cause mortality occurred in patients treated for nosocomial pneumonia, bloodstream infections, or sepsis. The 28-Day all-cause mortality was higher in patients treated with Fetroja than in patients treated with BAT [25/101 (24.8%) vs 9/49 (18.4%), treatment difference 6.4%, 95% CI (-8.6, 19.2)]. All-cause mortality remained higher in patients treated with Fetroja than in patients treated with BAT through Day 49 [34/101 (33.7%) vs 10/49 (20.4%), treatment difference 13.3%, 95% CI (-2.5, 26.9)]. Generally, deaths were in patients with infections caused by Gram-negative organisms, including non-fermenters such as Acinetobacter baumannii complex, Stenotrophomonas maltophilia, and Pseudomonas aeruginosa, and were the result of worsening or complications of infection, or underlying comorbidities. The cause of the increase in mortality has not been established.

 

Closely monitor the clinical response to therapy in patients with cUTI and HABP/VABP.

 

For Full US Prescribing Information, please visit Shionogi.com

 

Shionogi’s commitment to fighting antimicrobial resistance

Shionogi has a strong heritage in the field of anti-infectives and has been developing antimicrobial therapies for more than 60 years. Shionogi is proud to be one of the few large pharmaceutical companies that continue to focus on research and development in anti-infectives. The company invests the highest proportion of its pharmaceutical revenues in relevant anti-infectives R&D compared to other large pharmaceutical companies.1

 

For more information, please refer to: https://www.shionogi.com/global/en/sustainability/amr.html

 

About Shionogi

Shionogi & Co., Ltd. is a Japanese major research-driven pharmaceutical company dedicated to bringing benefits to patients based on its corporate philosophy of “supplying the best possible medicine to protect the health and wellbeing of the patients we serve.” The company currently markets products in several therapeutic areas including anti-infectives, pain, cardiovascular diseases, and gastroenterology. Our pipeline is focused on infectious disease, pain, CNS, and oncology. For more information on Shionogi & Co., Ltd., visit https://www.shionogi.com/global/en/. Shionogi Inc. is the U.S. subsidiary of Shionogi & Co., Ltd. based in N.J. For more information on Shionogi Inc., please visit www.shionogi.com.

 

Forward Looking Statement

This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also, for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, unavailability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

1 Antimicrobial Resistance Benchmark 2020.

https://accesstomedicinefoundation.org/media/uploads/downloads/5f3f76733efaa_Antimicrobial_Resistance_Benchmark_2020.pdf Last accessed September 2021.

Contacts

Lindsay Bohlander, Senior Director, Corporate Planning & Communications

+1 973-307-3718

Lindsay.Bohlander@shionogi.com