Tag: Oncology

Bayer and Orion expand development program for NUBEQA® (darolutamide) in prostrate cancer

Post author By Michelle Dryden
Post date February 8, 2021
No Comments on Bayer and Orion expand development program for NUBEQA® (darolutamide) in prostrate cancer

Phase III study ARANOTE to be initiated in metastatic hormone-sensitive prostate cancer (mHSPC) assessing the androgen receptor inhibitor (ARi) in combination with standard androgen deprivation therapy (ADT)
Start of patient enrollment expected by the end of Q1 2021
Study adds to the robust development program for NUBEQA, exploring an opportunity to help even more patients with prostate cancer

WHIPPANY, N.J. — (BUSINESS WIRE) — Bayer and Orion Corporation are expanding the global clinical development program for the oral androgen receptor inhibitor (ARi) NUBEQA^®(darolutamide) in prostate cancer. A new Phase III study ARANOTE will investigate NUBEQA in addition to androgen deprivation therapy (ADT) versus placebo plus ADT in men with metastatic hormone-sensitive prostate cancer (mHSPC). The study builds on the robust development program comprising multiple studies, including the Phase III study ARASENS, which investigates NUBEQA combined with ADT and docetaxel compared to docetaxel and ADT alone in men with mHSPC.

“NUBEQA has already shown in men with non-metastatic castration-resistant prostate cancer (nmCRPC) that it extends metastasis-free and overall survival,” said Scott Z. Fields, M.D., Senior Vice President and Head of Oncology Development at Bayer’s Pharmaceutical Division. “Given the encouraging results that we have seen with NUBEQA so far, it is important that we also evaluate the potential of NUBEQA in other stages of prostate cancer that may offer men with mHSPC a new treatment option.”

In 2019, NUBEQA was approved in the U.S. for the treatment of patients with nmCRPC. The ARAMIS study demonstrated proven efficacy and tolerability, including significant improvement in metastasis-free survival (MFS). NUBEQA plus ADT showed the same low rate of permanent discontinuation due to adverse reactions compared to ADT alone (9% versus 9%). The most frequent adverse reactions requiring discontinuation in patients who received NUBEQA included cardiac failure (0.4%), and death (0.4%). Adverse reactions occurring more frequently in the NUBEQA arm (≥2% over placebo) were fatigue (16% versus 11%), pain in extremity (6% versus 3%) and rash (3% versus 1%). NUBEQA was not studied in women and there is a warning and precaution for embryo-fetal toxicity.¹

About the ARANOTE Trial

The ARANOTE trial will be a randomized, double-blind, placebo-controlled Phase III study of NUBEQA in addition to androgen deprivation therapy (ADT) versus placebo plus ADT in men with metastatic hormone-sensitive prostate cancer (mHSPC). The primary endpoint of this study is radiological progression-free survival (rPFS), as measured as the time from the date of randomization to the date of first documentation of radiological progressive disease or death due to any cause, whichever occurs first. The trial is expected to enroll about 555 men, with the first patients enrolled by the end of Q1 2021.

Data from the Phase III ARAMIS Trial

Previously published in The New England Journal of Medicine, results in 1,509 patients from the Phase III ARAMIS trial demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS), with a median of 40.4 months (n=955) with NUBEQA plus androgen deprivation therapy (ADT), more than double the 18.4 months (n=554) for placebo plus ADT (p<0.001). MFS is defined as the time from randomization to the time of first evidence of blinded independent central review (BICR)-confirmed distant metastasis or death from any cause within 33 weeks after the last evaluable scan, whichever occurred first.¹

Additionally, NUBEQA plus ADT showed a statistically significant improvement in the secondary endpoint of overall survival (OS) compared to placebo plus ADT, with a 31% reduction in risk of death (HR=0.69, 95% CI 0.53-0.88; p=0.003). OS was statistically significant despite 31% (n=170) of patients in the ADT arm crossing over to NUBEQA. In total, 55% (n=307) of patients in the ADT arm crossed over to NUBEQA or received another life-prolonging therapy prior to this analysis.¹

Dose interruptions due to an adverse reaction occurred in 13% of patients treated with NUBEQA. The most frequent adverse reactions requiring dosage interruption in patients who received NUBEQA included hypertension (0.6%), diarrhea (0.5%), and pneumonia (0.5%). Dose reductions due to an adverse reaction occurred in 6% of patients treated with NUBEQA. The most frequent adverse reactions requiring dosage reduction in patients treated with NUBEQA included fatigue (0.7%), hypertension (0.3%), and nausea (0.3 %).¹

About NUBEQA^® (darolutamide)¹

NUBEQA is an androgen receptor inhibitor (ARi) with a distinct chemical structure that competitively inhibits androgen binding, AR nuclear translocation, and AR-mediated transcription.¹ A Phase III study in metastatic hormone-sensitive prostate cancer (ARASENS) is ongoing. Information about this trial can be found at www.clinicaltrials.gov.

Developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company, NUBEQA is indicated for the treatment of men with nmCRPC.¹ The approvals of NUBEQA in the U.S., European Union (EU), and other global markets have been based on the pivotal Phase III ARAMIS trial data evaluating the efficacy and safety of NUBEQA plus androgen deprivation therapy (ADT) compared to ADT alone.¹ Filings in other regions are underway or planned.

INDICATION FOR NUBEQA (darolutamide)

NUBEQA^®(darolutamide) is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer.

IMPORTANT SAFETY INFORMATION FOR NUBEQA (darolutamide)

Embryo-Fetal Toxicity: Safety and efficacy of NUBEQA have not been established in females. NUBEQA can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment with NUBEQA and for 1 week after the last dose.

Adverse Reactions

Serious adverse reactions occurred in 25% of patients receiving NUBEQA and in 20% of patients receiving placebo. Serious adverse reactions in ≥1 % of patients who received NUBEQA were urinary retention, pneumonia, and hematuria. Overall, 3.9% of patients receiving NUBEQA and 3.2% of patients receiving placebo died from adverse reactions, which included death (0.4%), cardiac failure (0.3%), cardiac arrest (0.2%), general physical health deterioration (0.2%), and pulmonary embolism (0.2%) for NUBEQA.

Adverse reactions occurring more frequently in the NUBEQA arm (≥2% over placebo) were fatigue (16% vs 11%), pain in extremity (6% vs 3%) and rash (3% vs 1%).

Clinically significant adverse reactions occurring in ≥2% of patients treated with NUBEQA included ischemic heart disease (4.0% vs 3.4% on placebo) and heart failure (2.1% vs 0.9% on placebo).

Drug Interactions

Effect of Other Drugs on NUBEQA – Combined P-gp and strong or moderate CYP3A4 inducers decrease NUBEQA exposure, which may decrease NUBEQA activity. Avoid concomitant use.

Combined P-gp and strong CYP3A4 inhibitors increase NUBEQA exposure, which may increase the risk of NUBEQA adverse reactions. Monitor more frequently and modify NUBEQA dose as needed.

Effects of NUBEQA on Other Drugs – NUBEQA inhibits breast cancer resistance protein (BCRP) transporter. Concomitant use increases exposure (AUC) and maximal concentration of BCRP substrates, which may increase the risk of BCRP substrate-related toxicities. Avoid concomitant use where possible. If used together, monitor more frequently for adverse reactions, and consider dose reduction of the BCRP substrate.

NUBEQA inhibits OATP1B1 and OATP1B3 transporters. Concomitant use may increase plasma concentrations of OATP1B1 or OATP1B3 substrates. Monitor more frequently for adverse reactions and consider dose reduction of these substrates.

Review the prescribing information of drugs that are BCRP, OATP1B1, and OATP1B3 substrates when used concomitantly with NUBEQA.

For important risk and use information about NUBEQA, please see the accompanying full Prescribing Information.

About Metastatic Hormone-Sensitive Prostate Cancer

Prostate cancer is the second most commonly diagnosed malignancy in men worldwide. In 2018, an estimated 1.2 million men were diagnosed with prostate cancer, and about 358,000 died from the disease worldwide.²

At the time of diagnosis, most men have localized prostate cancer, meaning their cancer is confined to the prostate gland and can be treated with curative surgery or radiotherapy.^3,4 Upon relapse when the disease will metastasize or spread, androgen deprivation therapy (ADT) is the cornerstone of treatment for this hormone-sensitive disease. Approximately five percent of men will already suffer from prostate cancer with distant metastases when first diagnosed. Men with metastatic hormone-sensitive prostate cancer (mHSPC) will start their treatment with hormone therapy, such as ADT, androgen receptor inhibitor (ARi) plus ADT or a combination of the chemotherapy docetaxel and ADT. Despite this first-line treatment, most men with mHSPC will eventually progress to metastatic castration-resistant prostate cancer (mCRPC), which can impact survival.^5,6

About Oncology at Bayer

Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer now expands to six marketed products and several other assets in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

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 benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2019, the Group employed around 104,000 people and had sales of 43.5 billion euros. Capital expenditures amounted to 2.9 billion euros, R&D expenses to 5.3 billion euros. For more information, go to www.bayer.us.

BAYER, the Bayer Cross and NUBEQA are registered trademarks of Bayer.

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer 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.

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References

NUBEQA^® (darolutamide) tablets [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, January 2021.
GLOBOCAN 2018: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2018. CA: A Cancer Journal for Clinicians. https://onlinelibrary.wiley.com/doi/epdf/10.3322/caac.21492. Accessed February 2021.
Cancer.Net 2020: Prostate Cancer Statistics. https://www.cancer.net/cancer-types/prostate-cancer/statistics. Accessed February 2021.
American Cancer Society: Hormone Therapy for Prostate Cancer. https://www.cancer.org/cancer/prostate-cancer/treating/hormone-therapy.html. Accessed February 2021.
Siegel DA, O’Neil ME, Richards TB, Dowling NF, Weir HK. Prostate Cancer Incidence and Survival, by Stage and Race/Ethnicity — United States, 2001–2017. MMWR Morb Mortal Wkly Rep 2020;69:1473–1480. http://dx.doi.org/10.15585/mmwr.mm6941a1.
Ng, K., Smith, S., Shamash, J. Metastatic Hormone-Sensitive Prostate Cancer (mHSPC): Advances and Treatment Strategies in the First-Line Setting. Oncol Ther 8, 209–230 (2020). https://doi.org/10.1007/s40487-020-00119-z.

PP-NUB-US-0940-1

Contacts

Rose Talarico, Tel. +1 862.404.5302

E-Mail: rose.talarico@bayer.com

Tags #NUBEQA, ARANOTE, Bayer, Oncology, Orion Corporation, Phase II, Prostate Cancer, Prostate Cancer#NUBEQA

Healthcare

LabCorp and HealthEC launch transformative oncology care module

Post author By Michelle Dryden
Post date October 9, 2020
No Comments on LabCorp and HealthEC launch transformative oncology care module

New Software Tool Designed to Help Oncologists Improve Patient Outcomes and Achieve Cost-Saving Goals

Available Exclusively through LabCorp and Powered by HealthEC®

BURLINGTON, N.C. & EDISON, N.J.–(BUSINESS WIRE)–LabCorp (NYSE: LH), a leading global life sciences company that is focused on advancing health and guiding patient care decisions, and HealthEC, LLC, a leading provider of population health management solutions, today announced the launch of LabCorp’s Care Intelligence Oncology Module (Oncology Care Module). LabCorp’s Oncology Care Module is designed to empower oncologists to improve patient outcomes and achieve cost-savings by making it easier to access and compare key data points and performance metrics. Available exclusively through LabCorp, the single-platform solution connects claims and clinical systems using the LabCorp Care Intelligence™ application, powered by HealthEC®.

LabCorp’s Oncology Care Module helps oncology practices measure performance against critical quality and cost benchmarks, including value-based care objectives. The solution consolidates clinically relevant patient and practice data points to provide a more detailed, holistic view of each patient. As part of LabCorp’s Care Intelligence application, the Oncology Care Module integrates securely and seamlessly with electronic health records and other practice management tools and systems. It combines clinical, claims, pharmacogenomics, and staging data; genetic and other clinical laboratory test results; and the patient’s Eastern Cooperative Oncology Group Performance status in a format that is easy-to-use for busy physicians.

LabCorp’s Oncology Care Module provides clinicians with real-time access to critical information that can improve patient outcomes, manage costs, and optimize quality-of-life for patients. The solution also supports patient communications with their care team and allows for patient reported outcomes (ePRO) relevant to their care. Access to this data provides a more comprehensive picture of patient status than information captured through clinical visits alone. Additionally, the tool has the ability to identify patients who may qualify to participate in clinical studies of new treatments through Covance, LabCorp’s drug development business, as well as monitor the progress of patients who are participating in a study.

“LabCorp continues to look for more ways to improve outcomes for cancer patients through the unique combination of our capabilities in diagnostics, drug development, and technology,” said Dr. Brian Caveney, president of LabCorp Diagnostics. “Clinicians, patients, and managed care organizations are increasingly relying on data to identify new treatments, improve patient outcomes, and manage costs. Our Oncology Care Module brings together important information to meet those objectives and helps people make more informed decisions.”

“As new technologies transform cancer care, oncology practices need comprehensive support to run their operations efficiently and ensure patients receive quality care in today’s value-based care environment,” said Arthur Kapoor, chairman and chief executive officer at HealthEC. “We’re pleased to extend our collaboration with LabCorp and look forward to helping oncology providers optimize operations with advanced data aggregation and analytics solutions as the healthcare industry transitions from volume to value.”

For more information about the LabCorp Care Intelligence application, please visit https://www.labcorp.com/CareIntelligence.

About HealthEC

HealthEC, LLC, the 2019 Best in KLAS provider of population health management solutions, is on a mission to help its customers succeed with value-based care. HealthEC®, a single-platform solution, enables personalized healthcare by leveraging the power of connectivity and interoperability: connecting claims and clinical systems, enabling data-driven collaboration between payers and providers, and streamlining care coordination across the healthcare landscape. Organizations are empowered with comprehensive analytics and integrated, role-based tools that translate insights into strategies, address care gaps, and improve quality metrics. To learn more, visit us at www.HealthEC.com, Twitter, LinkedIn and Facebook.

About LabCorp

LabCorp (NYSE: LH), an S&P 500 company, is a leading global life sciences company that is deeply integrated in guiding patient care, providing comprehensive clinical laboratory and end-to-end drug development services. With a mission to improve health and improve lives, LabCorp delivers world-class diagnostics solutions, brings innovative medicines to patients faster, and uses technology to improve the delivery of care. LabCorp reported revenue of more than $11.5 billion in 2019.

To learn more about LabCorp, visit www.LabCorp.com, and to learn more about LabCorp’s drug development business, Covance, visit www.Covance.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements, including but not limited to statements with respect to scientific collaborations, customer contracts and relationships, the anticipated benefits of such collaboration and relationships, and the expected impact that the various collaborations and customer relationships may have on the Company’s financial results. Each of the forward-looking statements is subject to change based on various important factors, many of which are beyond the Company’s control, including without limitation, the Company’s ability to establish and maintain strategic partnerships and other scientific collaborations, competitive actions in the marketplace, and other unforeseen changes and general uncertainties in the marketplace, changes in government regulations, including healthcare reform, customer purchasing decisions, including changes in payer regulations or policies, adverse actions of governmental and other third-party payers, patient safety issues, changes in testing guidelines or recommendations. These factors, in some cases, have affected and in the future (together with other factors) could affect the Company’s ability to implement the Company’s business strategy and actual results could differ materially from those suggested by these forward-looking statements. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. The Company has no obligation to provide any updates to these forward-looking statements even if its expectations change. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Further information on potential factors, risks and uncertainties that could affect operating and financial results is included in the Company’s most recent Annual Report on Form 10-K and subsequent Forms 10-Q, including in each case under the heading RISK FACTORS, and in the Company’s other filings with the SEC.

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Contacts

LabCorp Contacts:
Media: Donald Von Hagen — 336-436-8263

Media@LabCorp.com

Investors: Clarissa Willett — 336-436-5076

Investor@LabCorp.com

HealthEC Contact:
Laura Porto — 732-652-1519

Laura.Porto@HealthEC.com

October 9, 2020

Tags HealthEC, LabCorp, Oncology, OncologyHealthEC

Healthcare

Merck presents promising new data for three investigational medicines from diverse and expansive oncology pipeline at ESMO Virtual Congress 2020

Researchers Share New Data for Vibostolimab (MK-7684), Merck’s Anti-TIGIT Therapy, as Monotherapy and in Combination With KEYTRUDA^® (pembrolizumab); First-Time Results for First-in-Class MK-4830 (Anti-ILT4 Therapy); and Late-Breaking Data for MK-6482 (HIF-2α Inhibitor)

Merck to Initiate Phase 3 Study of Vibostolimab in Non-Small Cell Lung Cancer in First Half of 2021

KENILWORTH, N.J.–(BUSINESS WIRE)–$MRK #MRK–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of new data for three investigational medicines in Merck’s diverse and expansive oncology pipeline: vibostolimab (MK-7684), an anti-TIGIT therapy; MK-4830, a first-in-class anti-ILT4 therapy; and MK-6482, an oral HIF-2α inhibitor. Data from cohort expansions of a Phase 1b trial evaluating vibostolimab, as monotherapy and in combination with KEYTRUDA, Merck’s anti-PD-1 therapy, in patients with metastatic non-small cell lung cancer (NSCLC; Abstract #1410P and Abstract #1400P), and first-time Phase 1 data for MK-4830 in patients with advanced solid tumors (Abstract #524O), demonstrated acceptable safety profiles for these two investigational medicines and early signals of anti-tumor activity. Additionally, late-breaking Phase 2 data for MK-6482 showed anti-tumor responses in von Hippel-Lindau (VHL) disease patients with clear cell renal cell carcinoma (RCC) and other tumors (Abstract #LBA26).

“The new data for these three investigational medicines are encouraging and highlight continued momentum in our rapidly expanding oncology pipeline,” Dr. Eric H. Rubin, senior vice president, early-stage development, clinical oncology, Merck Research Laboratories. “Over the past five years, KEYTRUDA has become foundational in the treatment of certain advanced cancers. Our broad oncology portfolio and promising pipeline candidates are a testament to our commitment to bring forward innovative new medicines to address unmet medical needs in cancer care.”

Vibostolimab (Anti-TIGIT Therapy): Early Findings in Metastatic NSCLC (Abstract #1410P and Abstract #1400P)

Vibostolimab in combination with KEYTRUDA was evaluated in patients with metastatic NSCLC who had not previously received anti–PD-1/PD-L1 therapy, but the majority of whom had received >1 prior lines of therapy (73%, n=30/41) in Abstract #1410P. In Part B of the first-in-human, open-label, Phase 1 trial (NCT02964013) all patients received vibostolimab (200 or 210 mg) in combination with KEYTRUDA (200 mg) on Day 1 of each three-week cycle for up to 35 cycles. The primary endpoints of the study were safety and tolerability. Secondary endpoints included objective response rate (ORR), duration of response (DOR) and progression-free survival (PFS) based on investigator review per RECIST v1.1. In this anti-PD-1/PD-L1 naïve study, vibostolimab in combination with KEYTRUDA had a manageable safety profile and demonstrated promising anti-tumor activity. Treatment-related adverse events (TRAEs) with vibostolimab in combination with KEYTRUDA occurred in 34 patients (83%). The most frequent TRAEs (≥20%) were pruritus (34%), hypoalbuminemia (29%) and pyrexia (20%). Grade 3-5 TRAEs occurred in six patients (15%). No deaths due to TRAEs occurred. Across all patients enrolled, treatment with vibostolimab in combination with KEYTRUDA demonstrated an ORR of 29% (95% CI, 16-46) and median PFS was 5.4 months (95% CI, 2.1-8.2). The median DOR was not reached (range, 4 to 17+ months). Among patients whose tumors express PD-L1 (tumor proportion score [TPS] ≥1%) (n=13), the ORR was 46% (95% CI, 19-75) and median PFS was 8.4 months (95% CI, 3.9-10.2). Among patients whose tumors express PD-L1 (TPS <1%) (n=12), the ORR was 25% (95% CI, 6-57), and median PFS was 4.1 months (95% CI, 1.9-not reached [NR]). PD-L1 status was not available for 16 patients. Median follow-up for the study was 11 months (range, 7 to 18).

Additional data from a separate cohort of the same Phase 1b trial evaluated vibostolimab as monotherapy (n=41) and in combination with KEYTRUDA (n=38) in patients with metastatic NSCLC whose disease progressed on prior anti-PD-1/PD-L1 therapy (Abstract #1400P). In the study, 78% of patients had received >2 lines of prior therapy. In the study, patients received vibostolimab monotherapy (200 or 210 mg) or vibostolimab (200 or 210 mg) in combination with KEYTRUDA (200 mg) on Day 1 of each three-week cycle for up to 35 cycles. The primary endpoints of the study were safety and tolerability. Secondary endpoints included ORR and DOR. Vibostolimab as monotherapy or in combination with KEYTRUDA had a manageable safety profile and demonstrated modest anti-tumor activity in patients whose disease was refractory to PD-1/PD-L1 inhibition, most of whom had previously received several lines of therapy for advanced disease prior to enrollment. Grade 3-5 TRAEs occurred in 15% of patients receiving vibostolimab monotherapy and 13% of patients receiving vibostolimab in combination with KEYTRUDA. The most common TRAEs (≥10% in either arm) were pruritus, fatigue, rash, arthralgia and decreased appetite. One patient died due to treatment-related pneumonitis in the vibostolimab and KEYTRUDA combination arm. The ORR was 7% (95% CI, 2-20) with vibostolimab monotherapy and 5% (95% CI, <1-18) with vibostolimab in combination with KEYTRUDA. The median DOR was 9 months (range, 9 to 9) with vibostolimab monotherapy and 13 months (range, 4+ to 13) with vibostolimab in combination with KEYTRUDA.

Data from these cohort expansion studies are encouraging and support the continued development of vibostolimab, which is being evaluated alone and in combination with KEYTRUDA across multiple solid tumors, including NSCLC and melanoma. In the ongoing Phase 2 KEYNOTE-U01 umbrella study (NCT04165798), substudy KEYNOTE-01A (NCT04165070) is evaluating vibostolimab in combination with KEYTRUDA plus chemotherapy for the first-line treatment of patients with advanced NSCLC who had not received prior treatment with an anti-PD-1/PD-L1. Merck plans to initiate a Phase 3 study of vibostolimab in NSCLC in the first half of 2021. Ongoing trials in melanoma include the Phase 1/2 KEYNOTE-U02 umbrella study comprised of three substudies evaluating vibostolimab in combination with KEYTRUDA across treatment settings (substudy 02A: NCT04305041, substudy 02B: NCT04305054 and substudy 02C: NCT04303169).

MK-4830 (Anti-ILT4 Therapy): Initial Results in Advanced Solid Tumors (Abstract #524O)

In this first-in-human Phase 1, open-label, multi-arm, multi-center, dose escalation study (NCT03564691), MK-4830, Merck’s first-in-class anti-ILT4 therapy, was evaluated as monotherapy (n=50) and in combination with KEYTRUDA (n=34) in patients with advanced solid tumors. The majority of patients enrolled in the study (51%) had received three or more prior lines of therapy. MK-4830 was administered intravenously at escalating doses every three weeks alone or in combination with KEYTRUDA (200 mg every three weeks). The primary endpoints of the dose escalation part of the study were safety and tolerability; Pharmacokinetics was a secondary endpoint, and exploratory objectives included ORR per RECIST v1.1, evaluation of receptor occupancy and immune correlates of response in blood and tumor.

Findings showed that MK-4830 as monotherapy and in combination with KEYTRUDA had an acceptable safety profile and demonstrated dose-related evidence of target engagement in patients with advanced solid tumors. No dose-limiting toxicities were observed; the maximum-tolerated dose was not reached. Any-grade adverse events were consistent with those associated with KEYTRUDA. Treatment-related AEs occurred in 54% (n=28/52) of patients who received MK-4830 in combination with KEYTRUDA and 48% (n=24/50) of patients who received MK-4830 monotherapy; the majority were Grade 1 and 2. Preliminary efficacy data showed an ORR of 24% (n=8/34) in patients who received MK-4830 in combination with KEYTRUDA. All responses occurred in heavily pretreated patients, including five who had progressed on prior anti-PD-1 therapy (n=5/11). Some patients received more than one year of treatment, and treatment is ongoing in several patients.

These early data support the continued development of MK-4830 in combination with KEYTRUDA in patients with advanced solid tumors. Expansion cohorts of this study include pancreatic adenocarcinoma, glioblastoma, head and neck squamous cell carcinoma (recurrent or metastatic; PD-L1 positive), advanced NSCLC and gastric cancer.

MK-6482 (HIF-2α Inhibitor): Results in VHL-Associated RCC and Non-RCC Tumors (Abstract #LBA26)

In this Phase 2, open-label, single-arm trial, MK-6482 was evaluated for the treatment of VHL-associated RCC (NCT03401788). New data include findings for MK-6482 in VHL patients with non-RCC tumors and updated data in VHL patients with RCC. First-time data in VHL-associated RCC were presented in the virtual scientific program of the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting. The study enrolled adult patients with a pathogenic germline VHL variation, measurable localized or non-metastatic RCC, no prior systemic anti-cancer therapy, and Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. Patients received MK-6482 120 mg orally once daily until disease progression, unacceptable toxicity, or investigator’s or patient’s decision to withdraw. The primary endpoint was ORR of VHL-associated RCC tumors per RECIST v1.1 by independent radiology review. Secondary endpoints included DOR, time to response, PFS, efficacy in non-RCC tumors, and safety and tolerability.

Promising clinical activity continues to be observed with MK-6482 in treatment-naïve patients with VHL-associated RCC. Among 61 patients, results showed a confirmed ORR of 36.1% (95% CI, 24.2-49.4); all responses were partial responses, and 38% of patients had stable disease. The median time to response was 31.1 weeks (range, 11.9 to 62.3), and median DOR was not yet reached (range, 11.9 to 62.3 weeks). Additionally, 91.8% (n=56) of patients had a decrease in size of target lesions. Median PFS has not been reached, and the PFS rate at 52 weeks was 98.3%. Median duration of treatment was 68.7 weeks (range, 18.3 to 104.7), and 91.8% of patients were still on therapy after a minimum follow-up of 60 weeks.

In patients with non-RCC tumors, results in those with pancreatic lesions (n=61) showed a confirmed ORR of 63.9% (95% CI, 50.6-75.8), with four complete responses and 35 partial responses. Additionally, 34.4% had stable disease. In those with central nervous system (CNS) hemangioblastoma (n=43), results showed a confirmed ORR of 30.2% (95% CI, 17.2-46.1), with five complete responses and eight partial responses. Additionally, 65.1% had stable disease. In patients with retinal lesions (n=16), 93.8% of patients had improved or stable response.

In this Phase 2 study, TRAEs occurred in 98.4% of patients, and there were no Grade 4-5 TRAEs. The most common all-cause adverse events (≥20%) were anemia (90.2%), fatigue (60.7%), headache (37.7%), dizziness (36.1%) and nausea (31.1%). Grade 3 all-cause adverse events included anemia (6.6%), fatigue (4.9%) and dyspnea (1.6%). One patient discontinued treatment due to a TRAE (Grade 1 dizziness).

As announced, data spanning more than 15 types of cancer will be presented from Merck’s broad oncology portfolio and investigational pipeline at the congress. A compendium of presentations and posters of Merck-led studies is available here. Follow Merck on Twitter via @Merck and keep up to date with ESMO news and updates by using the hashtag #ESMO20.

About Vibostolimab

Vibostolimab is an anti-TIGIT therapy discovered and developed by Merck. Vibostolimab binds to TIGIT and blocks the interaction between TIGIT and its ligands (CD112 and CD155), thereby activating T lymphocytes which help to destroy tumor cells. The effect of combining KEYTRUDA with vibostolimab – blocking both the TIGIT and PD-1 pathways simultaneously – is currently being evaluated across multiple solid tumors, including NSCLC and melanoma.

About MK-4830

MK-4830 is a novel antibody directed against the inhibitory immune checkpoint receptor immunoglobulin-like transcript 4 (ILT4). Unlike current T cell-targeted antibodies (e.g., anti-PD1, anti-CTLA-4), anti-ILT4 is believed to attenuate immunosuppression imposed by tolerogenic myeloid cells in the tumor microenvironment. MK-4830 is currently being evaluated alone and in combination with KEYTRUDA across multiple solid tumors as part of ongoing Phase 1 and 2 trials.

About MK-6482

MK-6482 is an investigational, novel, potent, selective, oral HIF-2α inhibitor that is currently being evaluated in a Phase 3 trial in advanced RCC (NCT04195750), a Phase 2 trial in VHL-associated RCC (NCT03401788), and a Phase 1/2 dose-escalation and dose-expansion trial in advanced solid tumors, including advanced RCC (NCT02974738). Proteins known as hypoxia-inducible factors, including HIF-2α, can accumulate in patients when VHL, a tumor-suppressor protein, is inactivated. The accumulation of HIF-2α can lead to the formation of both benign and malignant tumors. This inactivation of VHL has been observed in more than 90% of RCC tumors. Research into VHL biology that led to the discovery of HIF-2α was awarded the Nobel Prize in Physiology or Medicine in 2019.

About KEYTRUDA^® (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-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 1,200 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

Melanoma

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

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) 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.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. 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 confirmatory trials.

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 head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy. 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.

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. 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 confirmatory trials. 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 cisplatin-containing chemotherapy and whose tumors express PD-L1 [combined positive score (CPS) ≥10], as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

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

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) 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, or
colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan.

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 first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. 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 recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

KEYTRUDA 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. 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.

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 patients with advanced renal cell carcinoma (RCC).

Tumor Mutational Burden-High

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] 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.

Contacts

Media Contacts:

Pamela Eisele

(267) 305-3558

Justine Moore

(908) 740-6449

Investor Contacts:

Peter Dannenbaum

(908) 740-1037

Courtney Ronaldo

(908) 740-6132

Read full story here

Tags #ESMO, Data, medicines, Merck, Oncology, Phase 3, Pipeline, Virtual Congress, Virtual Congress#ESMO

Healthcare

OncLive® names the 2020 class of Giants of Cancer Care®

Post author By Michelle Dryden
Post date September 17, 2020
No Comments on OncLive® names the 2020 class of Giants of Cancer Care®

Annual recognition program will honor 15 world-renowned leaders who have achieved landmark success within the global field of oncology

CRANBURY, N.J.–(BUSINESS WIRE)–#Breast–OncLive^®, the nation’s leading multimedia resource focused on providing oncology professionals with relevant, insightful information on patient care, is pleased to announce the Eighth Annual Giants of Cancer Care^® class of inductees. The virtual awards ceremony will be held on Nov. 5^th at 7.30 pm EST and will be available on-demand at www.giantsofcancercare.com after the conclusion of the event.

“The members of the 2020 class of Giants of Cancer Care^® are oncology legends who have made remarkable differences in the cancer care landscape,” said Mike Hennessy Jr., president and CEO of MJH Life Sciences^™, the parent company of OncLive^®. “Each inductee has worked tirelessly to advance the field of oncology with their contributions in research and clinical practice, and we look forward to recognizing these respected health care professionals at this year’s Giants of Cancer Care^® virtual celebration in November.”

This year’s Giants of Cancer Care^® inductees by award category are:

Breast Cancer — Martine J. Piccart, M.D., Ph.D., Université Libre de Bruxelles and Jules Bordet Institute.
Cancer Diagnostics — Laura J. van ’t Veer, Ph.D., Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco.
Community Outreach/Cancer Policy — Clifford A. Hudis, M.D., American Society of Clinical Oncology.
Education — Hope S. Rugo, M.D., FASCO, Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco.
Gastrointestinal Cancer — Margaret A. Tempero, M.D., Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco.
Genitourinary Cancer — Dean F. Bajorin, M.D., Memorial Sloan Kettering Cancer Center and Weill Medical College of Cornell University.
Gynecologic Malignancies — Robert L. Coleman, M.D., The US Oncology Network.
Leukemia — Susan M. O’Brien, M.D., Chao Family Comprehensive Cancer Center, University of California, Irvine.
Lung Cancer — Tony S.K. Mok, M.D., The Chinese University of Hong Kong.
Lymphoma — George P. Canellos, M.D., Dana-Farber Cancer Institute and Harvard Medical School.
Melanoma & Other Skin Cancers — Keith T. Flaherty, M.D., Massachusetts General Hospital Cancer Center and Harvard Medical School.
Myeloma — Sagar Lonial, M.D., Winship Cancer Institute of Emory University.
Prevention/Genetics — Olufunmilayo Falusi Olopade, M.D., University of Chicago Medicine.
Supportive, Palliative, and/or Geriatric Care — Richard J. Gralla, M.D., Albert Einstein College of Medicine and Jacobi Medical Center.
Translational Science — Maura L. Gillison, M.D., Ph.D., The University of Texas MD Anderson Cancer Center.

The Giants of Cancer Care^® program has celebrated more than 98 oncology legends since 2013 for their groundbreaking achievements in oncology research and clinical practice. Individuals named Giants of Cancer Care^®have reached landmark successes within the global field of oncology and their work has significantly impacted patient care and research. Out of 818 nominations, only 15 oncologists were selected to the prestigious 2020 class of Giants of Cancer Care^®.

The Giants of Cancer Care^® Steering Committee selects semifinalists from nominations submitted each year and the Selection Committee—comprised of more than 120 eminent oncologists, clinicians and researchers—then votes on the finalists in each category.

For more information and to register to attend the virtual awards ceremony, click here.

Supporters of the 2020 program include Athenex, Incyte, and Pfizer.

About OncLive^®

OncLive^® is a digital platform of resources offering oncology professionals the information they need to provide the best patient care. OncLive^® is a brand of MJH Life Sciences^™, the largest privately held, independent, full-service medical media company in North America dedicated to delivering trusted health care news across multiple channels.

About Giants of Cancer Care^®

Giants of Cancer Care^® celebrates the achievements of leading researchers and educators whose discoveries have helped propel the field of oncology forward and established the building blocks for future advances. Every year, a selection committee of more than 120 eminent oncologists, researchers and clinicians chooses honorees from several types of tumor and specialty categories.

Contacts

OncLive^® Media

John Patricolo, 609-325-4630

jpatricolo@mjhlifesciences.com

Tags #Breast, #OncLive, Giants of Cancer Care, Inductees, Oncology, Patient, Patient#Breast

Healthcare

Legend Biotech reports second quarter 2020 financial results

Post author By Michelle Dryden
Post date August 29, 2020
No Comments on Legend Biotech reports second quarter 2020 financial results

SOMERSET, N.J.–(BUSINESS WIRE)–Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, today reported financial results for the quarter ended June 30, 2020.

“Legend Biotech continues to execute on our corporate strategy, advancing the development of our lead product candidate, ciltacabtagene autoleucel (cilta-cel), in collaboration with Janssen Biotech, Inc. as well as our other pipeline programs,” said Frank Zhang, Ph.D., Chief Executive Officer and Chairman of the Board of Legend Biotech. “We look forward to presenting data from the CARTITUDE-1 study at a major medical conference in the second half of 2020.”

Second Quarter 2020 & Recent Highlights

Collaborative Research and License Agreement with Noile-Immune Biotech. On April 27, 2020, Legend Biotech entered into a collaborative research and license agreement with Noile-Immune Biotech Inc. pursuant to which Legend Biotech obtained a license to develop and commercialize next-generation CAR-T and/or TCR-T cell therapies incorporating Noile-Immune’s PRIME (proliferation-inducing and migration-enhancing) technology for up to two targets for all indications.
Updated Results from Janssen sponsored Phase 1b/2 CARTITUDE-1 study. On May 13, 2020, Legend Biotech announced positive follow up data (median of 11.5 months) from the Phase 1b portion of the CARTITUDE-1 study evaluating cilta-cel¹ (JNJ-4528) in heavily pretreated patients with relapsed or refractory multiple myeloma (RRMM).
Appointment of Three New Directors. In May 2020, Dr. Corazon (Corsee) Dating Sanders, Dr. Darren Ji, and Mr. Philip Yau joined Legend Biotech’s Board of Directors.
Successful Initial Public Offering. On June 9, 2020, Legend Biotech successfully completed its initial public offering for total gross proceeds of approximately $487.3 million.
Appointment of Dr. Frank Zhang as CEO. On August 1, 2020, the Board of Directors of Legend Biotech appointed Dr. Frank Zhang to serve as Chief Executive Officer, succeeding Dr. Yuan Xu upon her resignation.
First Breakthrough Therapy Designation from China CDE. On August 5, 2020, Legend Biotech announced that the China Center for Drug Evaluation (“CDE”), National Medical Products Administration recommended Breakthrough Therapy Designation (“BTD”) for cilta-cel for the treatment of adults with relapsed/refractory multiple myeloma. The designation was granted on August 13, 2020, making cilta-cel the first investigational product to obtain BTD in China.

Key Upcoming Milestones

Legend Biotech, in collaboration with Janssen Biotech, Inc., anticipates the presentation of data from the CARTITUDE-1 study at a major medical conference in the second half of 2020.
Janssen Biotech, Inc., Legend Biotech’s collaboration partner, expects to initiate the BLA filing for cilta-cel to the U.S. FDA by the end of 2020 and also expects that a marketing authorization application will be submitted to the European Medicines Agency (“EMA”) in early 2021.
Legend Biotech expects to use the data from CARTIFAN-1 in support of a regulatory submission for approval in China in 2021.
Legend Biotech intends to submit an IND application for LB1901 in relapsed or refractory T cell Lymphoma (“TCL”) in the second half of 2020.

The extent to which the COVID-19 may impact our business and clinical trials is highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration of the outbreak and social distancing regulations, travel restrictions, business closures or business disruptions and the effectiveness of actions taken in the United States and other countries to contain and treat the disease.

Financial Results for the Quarter Ended June 30, 2020

Cash and Cash Equivalents:

As of June 30, 2020, Legend Biotech had approximately $562.4 million of cash and cash equivalents and approximately $75.6 million in time deposits.

Revenue

Revenue for the three months ended June 30, 2020 was $11.6 million compared to $10.1 million for the three months ended June 30, 2019. This increase of $1.5 million was primarily due to additional milestone payments from Janssen Biotech, Inc. that were achieved in late 2019, which resulted in additional consideration being allocated to steering committee service for the three month ended June 30, 2020. Revenue for the three months ended June 30, 2020 and June 30, 2019 consisted of recognition of upfront and milestone payments allocated to steering committee service pursuant to the license and collaboration agreement with Janssen Biotech, Inc. Legend Biotech has not generated any revenue from product sales to date.

Research and Development Expenses

Research and development expenses for the three months ended June 30, 2020 were $53.6 million compared to $32.6 million for the three months ended June 30, 2019. This increase of $21.0 million was primarily due to a higher number of clinical trials, a higher number of patients enrolled in those trials and a higher number of research and development product candidates in the three months ended June 30, 2020.

Administrative Expenses

Administrative expenses for the three months ended June 30, 2020 were $4.5 million compared to $1.6 million for the three months ended June 30, 2019. This increase of $2.9 million was primarily due to Legend Biotech’s expansion of supporting administrative functions to aid continued research and development activities.

Selling and Distribution Expenses

Selling and distribution expenses for the three months ended June 30, 2020 were $9.6 million compared to $5.0 million for the three months ended June 30, 2019. This increase of $4.6 million was primarily due to increased costs associated with commercial preparation activities for cilta-cel.

Other Income and Gains

Other income and gains for the three months ended June 30, 2020 was $1.3 million compared to $1.2 million for the three months ended June 30, 2019.

Fair Value Loss of Convertible Redeemable Preferred Shares

For the three months ended June 30, 2020, Legend Biotech reported a one-time non-cash charge of $80.0 million caused by changes of fair value of Series A convertible redeemable preferred shares (Series A Preferred Shares). Upon listing on the Nasdaq Global Market, all outstanding Series A Preferred Shares were converted into ordinary shares of Legend Biotech and all accrued but unpaid dividends were settled in the form of ordinary shares of Legend Biotech.

Loss for the Period

For the three months ended June 30, 2020, net loss was $134.9 million, or $0.63 per share, compared to a net loss of $28.8 million, or $0.14 per share, for the three months ended June 30, 2019.

About Legend Biotech

Legend Biotech is a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications. Our team of over 700 employees across the United States, China and Europe, along with our differentiated technology, global development, and manufacturing strategies and expertise, provide us with the strong potential to discover, develop, and manufacture best-in-class cell therapies for patients in need.

We are engaged in a strategic collaboration with Janssen Biotech, Inc. to develop and commercialize our lead product candidate, ciltacabtagene autoleucel, an investigational BCMA-targeted CAR-T cell therapy for patients living with multiple myeloma. This candidate is currently being studied in registrational clinical trials.

Cautionary Note Regarding Forward-Looking Statements

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Legend Biotech’s strategies and objectives; the anticipated timing of, and ability to progress, clinical trials; the ability to make, and the timing of, regulatory submissions in the United States, Europe and Asia, including the BLA filing for cilta-cel to the U.S. FDA, the submission of a marketing authorization application for cilta-cel to the EMA, and the submission of an IND LB1901 in relapsed or refractory TCL; the ability to generate, analyze and present data from clinical trials; patient enrollment; and the potential benefits of our product candidates. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the factors discussed in the “Risk Factors” section of the prospectus filed with the Securities and Exchange Commission on June 8, 2020. Any forward-looking statements contained in this press release speak only as of the date hereof, and Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Readers should not rely upon the information on this page as current or accurate after its publication date.

LEGEND BIOTECH CORPORATION

UNAUDITED INTERIM CONDENSED

CONSOLIDATED STATEMENTS OF PROFIT OR LOSS

FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2020 AND 2019

	Three months ended June 30		Six months ended June 30
(in thousands, US$, except share and per share data)	2020 (unaudited)	2019 (unaudited)	2020 (unaudited)	2019 (unaudited)
(in thousands, US$, except share and per share data)	2020 (unaudited)	2019 (unaudited)	2020 (unaudited)	2019 (unaudited)
REVENUE	11,600	10,087	23,146	20,140
Other income and gains	1,265	1,221	3,796	4,073
Research and development expenses	(53,567)	(32,640)	(101,570)	(53,929)
Administrative expenses	(4,508)	(1,607)	(7,938)	(2,712)
Selling and distribution expenses	(9,557)	(5,030)	(16,102)	(7,786)
Other expenses	(37)	(478)	(82)	(625)
Fair value loss of convertible redeemable preferred shares	(79,984)	—	(79,984)	—
Finance costs	(88)	(19)	(4,079)	(57)


LOSS BEFORE TAX	(134,876)	(28,466)	(182,813)	(40,896)
Income tax (expense)/credit	—	(336)	3,709	(336)
LOSS FOR THE PERIOD	(134,876)	(28,802)	(179,104)	(41,232)
Attributable to:
Equity holders of the parent	(134,876)	(28,802)	(179,104)	(41,232)
LOSS PER SHARE ATTRIBUTABLE TO ORDINARY EQUITY HOLDERS OF THE PARENT
Ordinary shares—basic	(0.63)	(0.14)	(0.86)	(0.21)
Ordinary shares—diluted	(0.63)	(0.14)	(0.86)	(0.21)
Ordinary shares used in loss per share computation:
Ordinary shares—basic	215,551,887	200,000,000	207,775,944	200,000,000
Ordinary shares—diluted	215,551,887	200,000,000	207,775,944	200,000,000

LEGEND BIOTECH CORPORATION

UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION AS AT JUNE 30, 2020 AND DECEMBER 31, 2019

	June 30, 2020 (Unaudited)	December 31, 2019
(in thousands, US$)
NON-CURRENT ASSETS
Property, plant and equipment	88,589	70,079
Advance payments for property, plant and equipment	2,121	665
Right-of-use assets	7,786	9,348
Intangible assets	978	519
Total non-current assets	99,474	80,611
CURRENT ASSETS
Inventories	1,668	1,157
Trade receivables	—	29,991
Prepayments, other receivables and other assets	33,517	16,777
Pledged short-term deposits	256	256
Time deposits	75,559	75,559
Cash and cash equivalents	562,391	83,364
Total current assets	673,391	207,104
Total assets	772,865	287,715
CURRENT LIABILITIES
Trade and notes payables	6,976	9,586
Other payables and accruals	60,429	70,854
Lease liabilities	1,314	1,027
Contract liabilities	46,312	46,294
Total current liabilities	115,031	127,761
NON-CURRENT LIABILITIES
Contract liabilities	254,714	277,765
Lease liabilities	2,119	5,058
Total non-current liabilities	256,833	282,823
Total liabilities	371,864	410,584
EQUITY
Share capital	26	20
Reserves/(deficits)	400,975	(122,889)
Total ordinary shareholders’ equity/(deficit)	401,001	(122,869)
Total equity/(deficit)	401,001	(122,869)
Total liabilities and equity	772,865	287,715

LEGEND BIOTECH CORPORATION

UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2020 AND 2019

	Three months ended June 30		Six months ended June 30
(in thousands, US$)	2020 (Unaudited)	2019 (Unaudited)	2020 (Unaudited)	2019 (Unaudited)
LOSS BEFORE TAX	(134,876)	(28,466)	(182,813)	(40,896)
CASH FLOWS USED IN OPERATING ACTIVITIES	(56,885)	(38,766)	(102,681)	(43,025)
CASH FLOWS USED IN INVESTING ACTIVITIES	(9,212)	(36,031)	(26,711)	(150,909)
CASH FLOWS FROM/(USED IN) FINANCING ACTIVITIES	459,803	(7,177)	608,558	21,500
NET INCREASE/(DECREASE) IN CASH AND CASH EQUIVALENTS	393,706	(81,974)	479,166	(172,434)
Effect of foreign exchange rate changes, net	(112)	(16)	(139)	(11)
Cash and cash equivalents at beginning of the period	168,797	119,711	83,364	210,166
CASH AND CASH EQUIVALENTS AT END OF THE PERIOD.	562,391	37,721	562,391	37,721
ANALYSIS OF BALANCES OF CASH AND CASH EQUIVALENTS
Cash and bank balances	638,206	149,032	638,206	149,032
Less: Pledged short-term deposits	256	250	256	250
Time deposits	75,559	111,061	75,559	111,061
Cash and cash equivalents as stated in the statement of financial position	562,391	37,721	562,391	37,721
Cash and cash equivalents as stated in the statement of cash flows	562,391	37,721	562,391	37,721

¹tacabtagene autoleucel (cilta-cel) refers to both JNJ-4528 (the identifier for the investigational product being studied outside of China) and LCAR-B38M CAR-T cell (the identifier for the investigational product being studied in China), both of which identify the same CAR-T cell therapy.

Contacts

Media and Investor Relations:

Jessie Yeung, Head of Corporate Finance and Investor

Relations, Legend Biotech jessie.yeung@legendbiotech.com or

investor@legendbiotech.com

Tags #Results, Biopharmaceutical, Clinical, Financial, Global, Healthcare, Legend Biotech, Oncology, Second Quarter, Therapies, Therapies#Results

Healthcare

Merck’s KEYTRUDA® (pembrolizumab) receives two new approvals in Japan

Post author By Michelle Dryden
Post date August 24, 2020
No Comments on Merck’s KEYTRUDA® (pembrolizumab) receives two new approvals in Japan

KEYTRUDA Now Approved for Patients With PD-L1-Positive Esophageal Squamous Cell Carcinoma Who Have Progressed After Chemotherapy and for a Six-Week Dosing Schedule Across All Adult Indications

Six-Week Dosing Schedule for KEYTRUDA Now Approved in Japan, US and Europe

KENILWORTH, N.J.–(BUSINESS WIRE)–$MRK #MRK–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that KEYTRUDA, Merck’s anti-PD-1 therapy, has received two new approvals from the Japan Pharmaceuticals and Medical Devices Agency (PMDA). KEYTRUDA monotherapy is now approved for the treatment of patients whose tumors are PD-L1-positive, and have radically unresectable, advanced or recurrent esophageal squamous cell carcinoma (ESCC) who have progressed after chemotherapy. Additionally, KEYTRUDA was approved for use at an additional recommended dosage of 400 mg every six weeks (Q6W) administered as an intravenous infusion over 30 minutes across all adult indications, including KEYTRUDA monotherapy and combination therapy. This new dosage option will be available in addition to the current dose of 200 mg every three weeks (Q3W). With these approvals, KEYTRUDA has 13 indications across seven tumor types plus MSI-H tumors in Japan.

“We remain committed to improving outcomes for as many patients with cancer as possible, including those with esophageal squamous cell carcinoma, which is a leading cause of cancer-related death in Japan,” said Dr. Jonathan Cheng, vice president, oncology clinical research, Merck Research Laboratories. “With today’s approvals, specific patients with esophageal cancer can receive a much-needed new treatment option, and adult patients receiving KEYTRUDA will now have the option of a dosing schedule that reduces how often they are at the clinic for treatment.”

The approval for KEYTRUDA for the treatment of certain patients with ESCC is based on results from the global Phase 3 KEYNOTE-181 trial, in which an improvement in overall survival (OS) was observed for KEYTRUDA monotherapy compared with chemotherapy (paclitaxel, docetaxel or irinotecan) in patients with recurrent or metastatic ESCC whose tumors expressed PD-L1 (CPS ≥10) (HR=0.64 [95% CI, 0.46-0.90]). The median OS was 10.3 months (95% CI, 7.0-13.5) for KEYTRUDA compared with 6.7 months (95% CI, 4.8-8.6) for chemotherapy.

The approval of KEYTRUDA for a Q6W dosing regimen is based on pharmacokinetic modeling and exposure-response analyses. The pharmacokinetic modeling data was supported by an interim analysis of pharmacokinetic, efficacy and safety data from KEYNOTE-555 from a cohort of patients (Cohort B) treated with KEYTRUDA 400 mg Q6W.

“In Japan, more than 90% of esophageal cancers are squamous cell carcinomas. Patients with advanced disease face a poor prognosis and are in critical need of new treatment options,” said Jannie Oosthuizen, president, MSD Japan. “These approvals reinforce our commitment to innovative research that will continue to help more patients with cancer in Japan.”

About Esophageal Cancer in Japan

Esophageal cancer, a type of cancer that is particularly difficult to treat, begins in the inner layer (mucosa) of the esophagus and grows outward. There are two main types of esophageal cancer: squamous cell carcinoma and adenocarcinoma. In Japan, more than 90% of all esophageal cancers are squamous cell carcinomas. Globally, esophageal cancer is the seventh most commonly diagnosed cancer, and it is estimated there were more than 572,000 new esophageal cancer cases and nearly 509,000 deaths resulting from the disease in 2018.

About KEYTRUDA^® (pembrolizumab) Injection, 100 mg

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 patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

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.

Small Cell Lung Cancer

Head and Neck Squamous Cell Cancer

Classical Hodgkin Lymphoma

Primary Mediastinal Large B-Cell Lymphoma

Urothelial Carcinoma

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, or
colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

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

Gastric Cancer

Esophageal Cancer

Cervical Cancer

Hepatocellular Carcinoma

Merkel Cell Carcinoma

Renal Cell Carcinoma

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

Tumor Mutational Burden-High

Cutaneous Squamous Cell Carcinoma

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

Adult Indications: Additional Dosing Regimen of 400 mg Every 6 Weeks

KEYTRUDA is indicated for use at an additional recommended dosage of 400 mg every 6 weeks for all approved adult indications. This indication is approved under accelerated approval based on pharmacokinetic data, the relationship of exposure to efficacy, and the relationship of exposure to safety. Continued approval for this dosing may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Selected Important Safety Information for KEYTRUDA

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 3.4% (94/2799) of patients with various cancers receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%). Pneumonitis occurred in 8.2% (65/790) of NSCLC patients receiving KEYTRUDA as a single agent, including Grades 3-4 in 3.2% of patients, and occurred more frequently in patients with a history of prior thoracic radiation (17%) compared to those without (7.7%). Pneumonitis occurred in 6% (18/300) of HNSCC patients receiving KEYTRUDA as a single agent, including Grades 3-5 in 1.6% of patients, and occurred in 5.4% (15/276) of patients receiving KEYTRUDA in combination with platinum and FU as first-line therapy for advanced disease, including Grades 3-5 in 1.5% of patients.

Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%). Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Immune-Mediated Hepatitis (KEYTRUDA) and Hepatotoxicity (KEYTRUDA in Combination With Axitinib)

Immune-Mediated Hepatitis

KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%). Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hepatotoxicity in Combination With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA alone. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased ALT (20%) and increased AST (13%) were seen. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes 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.

Immune-Mediated Endocrinopathies

KEYTRUDA can cause adrenal insufficiency (primary and secondary), hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Adrenal insufficiency occurred in 0.8% (22/2799) of patients, including Grade 2 (0.3%), 3 (0.3%), and 4 (<0.1%). Hypophysitis occurred in 0.6% (17/2799) of patients, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%). Hypothyroidism occurred in 8.5% (237/2799) of patients, including Grade 2 (6.2%) and 3 (0.1%). The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC (16%) receiving KEYTRUDA, as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. Hyperthyroidism occurred in 3.4% (96/2799) of patients, including Grade 2 (0.8%) and 3 (0.1%), and thyroiditis occurred in 0.6% (16/2799) of patients, including Grade 2 (0.3%). Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 0.2% (6/2799) of patients.

Monitor patients for signs and symptoms of adrenal insufficiency, hypophysitis (including hypopituitarism), thyroid function (prior to and periodically during treatment), and hyperglycemia. For adrenal insufficiency or hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 adrenal insufficiency or hypophysitis and withhold or discontinue KEYTRUDA for Grade 3 or Grade 4 adrenal insufficiency or hypophysitis. Administer hormone replacement for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.

Immune-Mediated Nephritis and Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Nephritis occurred in 1.7% (7/405) of patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue for Grade 3 or 4 nephritis.

Immune-Mediated Skin Reactions

Immune-mediated rashes, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (some cases with fatal outcome), exfoliative dermatitis, and bullous pemphigoid, can occur. Monitor patients for suspected severe skin reactions and based on the severity of the adverse reaction, withhold or permanently discontinue KEYTRUDA and administer corticosteroids. For signs or symptoms of SJS or TEN, withhold KEYTRUDA and refer the patient for specialized care for assessment and treatment. If SJS or TEN is confirmed, permanently discontinue KEYTRUDA.

Other Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue in patients receiving KEYTRUDA and may also occur after discontinuation of treatment. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

The following clinically significant immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 2799 patients: arthritis (1.5%), uveitis, myositis, Guillain-Barré syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, sarcoidosis, and encephalitis. In addition, myelitis and myocarditis were reported in other clinical trials, including classical Hodgkin lymphoma, and postmarketing use.

Treatment with KEYTRUDA may increase the risk of rejection in solid organ transplant recipients. Consider the benefit of treatment vs the risk of possible organ rejection in these patients.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% (6/2799) of patients. Monitor patients for signs and symptoms of infusion-related reactions. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Immune-mediated complications, including fatal events, occurred in patients who underwent allogeneic HSCT after treatment with KEYTRUDA. Of 23 patients with cHL who proceeded to allogeneic HSCT after KEYTRUDA, 6 (26%) developed graft-versus-host disease (GVHD) (1 fatal case) and 2 (9%) developed severe hepatic veno-occlusive disease (VOD) after reduced-intensity conditioning (1 fatal case). Cases of fatal hyperacute GVHD after allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptor–blocking antibody before transplantation. Follow patients closely for early evidence of transplant-related complications such as hyperacute graft-versus-host disease (GVHD), Grade 3 to 4 acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease (VOD), and other immune-mediated adverse reactions.

In patients with a history of allogeneic HSCT, acute GVHD (including fatal GVHD) has been reported after treatment with KEYTRUDA. Patients who experienced GVHD after their transplant procedure may be at increased risk for GVHD after KEYTRUDA. Consider the benefit of KEYTRUDA vs the risk of GVHD in these patients.

Increased Mortality in Patients With Multiple Myeloma

In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality.

Contacts

Media:

Pamela Eisele

(267) 305-3558

Ayn Wisler

(908) 740-5590

Investors:

Peter Dannenbaum

(908) 740-1037

Courtney Ronaldo

(908) 740-6132

Read full story here

Tags #Canada, #Japan, #Therapy, Business, Healthcare, Keytruda, Merck, Oncology, Pembrolizumab, Tumors, Tumors#Canada

Healthcare

Bayer names Lori Moore as vice president, head of U.S. Pharmaceutical Communications

Post author By Michelle Dryden
Post date August 10, 2020
No Comments on Bayer names Lori Moore as vice president, head of U.S. Pharmaceutical Communications

WHIPPANY, N.J.–(BUSINESS WIRE)–Lori Moore, former Managing Director at Deloitte, will be joining Bayer as Vice President, Head of Pharmaceutical Communications in the United States, the company announced today.

Moore spent the last six years in senior communications roles at Deloitte, most recently as the Managing Director leading efforts to transform internal communications. Prior to joining Deloitte, Moore served in communications leadership positions at Novo Nordisk and Sanofi. In her new role at Bayer, Moore will be responsible for developing and executing external and internal communication strategies for the company’s pharmaceutical portfolio in the United States, with a specific emphasis on cardiology, oncology, women’s health, hematology and radiology.

Moore officially starts today and will be based in Whippany, N.J. She will report directly to Raymond F. Kerins, Jr., Senior Vice President of Corporate Affairs, and serve on the U.S. Corporate Affairs and Pharmaceutical Leadership Teams.

“I’m delighted to have Lori join the Bayer team as she brings more than 20 years of experience in the pharmaceutical industry,” Kerins said. “Her impressive knowledge and expertise will help us advance our communications about the company’s pharmaceutical business here in this country.”

Throughout her career, Moore has served in various positions leading marketing communications, corporate branding, internal communications and public relations. In her most recent role, she was responsible for transforming and implementing a new internal communications strategy to support the business needs at Deloitte. Earlier, she served as the head of communications for Deloitte’s audit and risk advisory business.

Prior to her time at Deloitte, Moore spent nine years at Novo Nordisk as the Executive Director for Communications and Public Affairs, where she oversaw all strategic communications, including brand and reputation management, crisis management and employee engagement in the United States. Earlier in her career, Moore managed the Global Product communications for Sanofi where she was responsible for the communications around product launches, programs and issues management.

“I’m honored to join the Bayer team at such a critical time of growth for the division,” Moore said. “Bringing innovative medicines to market is at the heart of what we do, and I look forward to communicating this important story with patients, physicians and providers throughout the United States.”

Moore holds a Master of Science degree in Communications from Northwestern University and a Bachelor of Arts in Journalism from Northern Illinois University.

About Bayer

Social Media Channels

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

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

Carolyn Nagle

Bayer U.S.

Email: carolyn.nagle@bayer.com
Mobile: 201-419-0337

Tags Bayer, Cardiology, Communications, Deloitte, Hematology, Lori Moore, Oncology, Pharmaceutical, U.S. Pharmaceutical Communications, U.S. Pharmaceutical CommunicationsBayer

Healthcare

Eagle Pharmaceuticals to discuss second quarter 2020 financial results on August 10, 2020

Post author By Michelle Dryden
Post date August 4, 2020
No Comments on Eagle Pharmaceuticals to discuss second quarter 2020 financial results on August 10, 2020

WOODCLIFF LAKE, N.J.–(BUSINESS WIRE)–Eagle Pharmaceuticals, Inc. (“Eagle” or the “Company”) (Nasdaq: EGRX) today announced that the Company will release its 2020 second quarter financial results on Monday, August 10, 2020, before the market opens.

Scott Tarriff, Chief Executive Officer, and Pete Meyers, Chief Financial Officer, will host a conference call to discuss the results as follows:

Date			Monday, August 10, 2020
Time			8:30 a.m. ET
Toll free (U.S.)			877-876-9173
International			785-424-1667
Webcast (live and replay)			www.eagleus.com, under the “Investor Relations” section

A replay of the conference call will be available for one week after the call’s completion by dialing 800-839-4014 (US) or 402-220-2983 (International) and entering conference call ID EGRXQ220. The webcast will be archived for 30 days at the aforementioned URL.

About Eagle Pharmaceuticals, Inc.

Eagle is a fully integrated pharmaceutical company with research and development, clinical, manufacturing and commercial expertise. Eagle is committed to developing innovative medicines that result in meaningful improvements in patients’ lives. Eagle’s commercialized products include RYANODEX^®, BENDEKA^®, BELRAPZO^®, and its oncology and CNS/metabolic critical care pipeline includes product candidates with the potential to address underserved therapeutic areas across multiple disease states. Additional information is available on Eagle’s website at www.eagleus.com.

Contacts

Investor Relations for Eagle Pharmaceuticals, Inc:
Lisa M. Wilson

T: 212-452-2793

E: lwilson@insitecony.com

Public Relations for Eagle Pharmaceuticals, Inc.:
Faith Pomeroy-Ward

T: 817-807-8044

E: faith@fpwservices.com

Tags #Investor, #Pharmaceuticals, #Results, #Second, Business, Clinical, Eagle, Oncology, patients, Pipeline, Quarter, Relations, Relations#Investor