Category: 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 announces Week 96 data from Phase 2b study evaluating Islatravir in combination with Doravirine in adults with HIV-1 infection

Treatment With Islatravir and Doravirine Maintained Viral Suppression and No Viral Resistance was Identified

Company Also Presenting Phase 1/1b Results for MK-8507, a New Investigational Once-Weekly Oral HIV Agent; Company Advances MK-8507 to Phase 2

KENILWORTH, N.J.–(BUSINESS WIRE)–$MRK #MRK–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced Week 96 data from the Phase 2b trial (NCT03272347) evaluating the efficacy and safety of islatravir, the company’s investigational oral nucleoside reverse transcriptase translocation inhibitor (NRTTI), in combination with doravirine (PIFELTRO™), in treatment-naïve adults with HIV-1 infection. Week 96 findings demonstrated that the combination of islatravir and doravirine maintained virologic suppression (as measured by the number of study participants achieving HIV-1 RNA levels <50 copies/mL, similar to DELSTRIGO™ (doravirine/lamivudine/tenofovir disoproxil fumarate)), and the findings were consistent with Week 48 results. Additional Week 96 data from the study show low rates of participants meeting the definition of protocol-defined virologic failure (PDVF) in both the islatravir plus doravirine and the DELSTRIGO treatment arms, and no participants in either arm met the criteria for resistance testing. Merck also announced results from Phase 1/1b studies for MK-8507, the company’s investigational once-weekly oral non-nucleoside reverse transcriptase inhibitor (NNRTI), which showed that the antiviral potency and pharmacokinetics of MK-8507 support further investigation for once-weekly oral administration as part of combination antiretroviral therapy. These analyses were presented as oral and poster presentations at the virtual 2020 International Congress on Drug Therapy in HIV Infection (HIV Glasgow 2020).

“Our commitment to medical advances in HIV can be seen in the important data we are presenting at HIV Glasgow 2020, including islatravir’s potential for use in combination with doravirine as a once-daily, two-drug treatment. In addition, we are presenting data on MK-8507, which is advancing to Phase 2 investigations in combination with islatravir as a once-weekly oral regimen,” said Dr. Joan Butterton, vice president, infectious diseases, Global Clinical Development, Merck Research Laboratories. “We continue to pursue new methods for treating HIV, as shown by our growing body of clinical research, and we look forward to sharing new data from our ongoing, global Phase 3 clinical trials for islatravir with doravirine in the future.”

PIFELTRO (doravirine, 100 mg) is indicated in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in adult patients with no prior ARV treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable ARV regimen with no history of treatment failure and no known substitutions associated with resistance to doravirine.

DELSTRIGO (doravirine 100 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg) is indicated as a complete regimen for the treatment of HIV-1 infection in adult patients with no prior ARV treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable ARV regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of DELSTRIGO. DELSTRIGO contains a boxed warning regarding post-treatment acute exacerbations of hepatitis B (HBV) infection. See Selected Safety Information below.

Week 96 Efficacy and Safety Results from Phase 2b Study of Investigational 2-Drug Regimen of Islatravir with Doravirine

In this international, multicenter clinical trial, treatment-naïve adult participants with HIV-1 infection were randomly assigned (1:1:1:1) to one of four once-daily oral treatment groups: islatravir 0.25 mg (n=29), 0.75 mg (n=30), or 2.25 mg (n=31) in combination with doravirine (100 mg) and 3TC (300 mg) compared to DELSTRIGO (n=31). After a minimum of 24 weeks of treatment, participants in the islatravir treatment groups with HIV-1 RNA less than 50 copies/mL who had not met protocol-defined virologic failure (PDVF) criteria were transitioned to a two-drug regimen consisting of the same dose of islatravir plus doravirine (100 mg), without 3TC. At Week 96, at all dose levels, the combination of islatravir and doravirine maintained virologic suppression as measured by the number of study participants achieving HIV-1 RNA levels <50 copies/mL. At Week 96, 86.2% (25/29), 90.0% (27/30), and 67.7% (21/31) of participants maintained HIV-1 RNA <50 copies/mL in the 0.25 mg, 0.75mg, and 2.25 mg islatravir groups, respectively, with 81.1% (73/90) of the combined islatravir groups, as compared to 80.6% (25/31) of the DELSTRIGO group. The numerically lower response rate for the 2.25 mg islatravir group was largely driven by discontinuations through Week 48.

A lower rate of drug-related adverse events (AEs) occurred in the islatravir groups (7.8%) compared with the DELSTRIGO group (22.6%) at Week 96. No additional drug-related serious adverse events were reported in any group between Week 48 and Week 96. Based on these results, the 0.75 mg dose of islatravir will be used for further clinical development.

Week 96 Protocol-Defined Virologic Failure (PDVF) Analysis from Phase 2b Study of Investigational 2-Drug Regimen of Islatravir with Doravirine

A Week 96 analysis of the study showed rates of PDVF were low, and all participants who discontinued due to PDVF had HIV-1 RNA levels <80 copies/mL, below the clinically significant level of 200 copies/mL. No participants met the criteria for resistance testing (HIV-1 RNA >400 copies/mL). PDVF was defined as rebound with confirmed HIV-1 RNA greater than or equal to 50 copies/mL after suppression or non-response with confirmed HIV-1 RNA greater than or equal to 50 copies/mL.

At Week 96, a total of seven participants met the definition of PDVF and discontinued from the trial. As previously reported, at Week 48, PDVF was confirmed in six participants, 5.6% (5/90; 4 rebound, 1 non-response) of the islatravir treatment groups combined and 3.2% (1/31; rebound) of the DELSTRIGO group. Only one additional participant in the 2.25 mg islatravir group discontinued with PDVF (rebound). None of the participants in any treatment group met criteria for resistance testing as all confirmed HIV-1 RNA for participants that met the definition of PDVF were <80 copies/mL. During the 42-day follow-up period, three out of seven participants who discontinued due to PDVF continued to have low-level viremia after switching to a new regimen.

Week 96 Renal Safety Analysis from Phase 2b Study of Investigational 2-Drug Regimen of Islatravir with Doravirine

A Week 96 exploratory analysis showed no renal safety concerns. Serum creatinine was measured at each study visit, including Day 1, Week 48, and Week 96. Estimated glomerular filtration rate (eGFR) was calculated by the Modification of Diet in Renal Disease (MDRD) formula.

Median changes in serum creatinine and eGFR were minimal in all treatment groups at Week 48 and Week 96. Two participants in the 0.25 mg islatravir group had isolated instances of ≥0.5 mg/dL increase from baseline in serum creatinine that resolved by the next study visit: at Week 16 (1.7 mg/dL) in one participant; at Week 60 (1.7 mg/dL) and Week 84 (1.9 mg/dL) in the other. No participants had ≥1.0 mg/dL increase or doubling of serum creatinine. eGFR reductions greater than 30% from baseline occurred in 12% (11/90) of islatravir-treated participants and 16% (5/31) of DELSTRIGO-treated participants and were transient in most cases. eGFR <60 mL/min/1.73 m² occurred in 4% (4/90) of islatravir-treated participants and were transient in three (the fourth had eGFR <60 mL/min/1.73 m² from baseline through Week 96). No clinically meaningful changes were observed in renal biomarkers, including urine albumin, albumin/creatinine ratio, beta-2 microglobulin/creatinine ratio, or retinol-binding protein/creatinine ratio. No dose-response relationship was observed for renal effects of islatravir in combination with doravirine, and no participant discontinued treatment due to a renal adverse event.

Phase 1/1b Results for MK-8507

Two randomized, double-blind, placebo-controlled Phase 1 clinical trials were conducted to evaluate the safety, tolerability and pharmacokinetics of single and multiple oral doses of MK-8507 and potential for drug-drug interaction with midazolam, a CYP3A substrate, in healthy adult participants. In Study 1, participants (n=16 males) received single doses of MK-8507 or placebo from 2 mg to 400 mg. In Study 2, participants (n=24 males and females) received single doses of MK-8507 or placebo from 400 mg to 1200 mg, and multiple doses of MK-8507 or placebo (once-weekly for three weeks) from 100 mg to 400 mg. At the 400 mg once-weekly dose level, participants also received 2 mg of midazolam prior to MK-8507 dosing and co-administered with the third once-weekly dose.

The pharmacokinetics of MK-8507 support once-weekly administration for the treatment of HIV-1 infection. MK-8507 had a T_max (time to maximum concentration) of two to seven hours and a mean terminal half-life (t_½) of approximately 58-84 hours. Pharmacokinetics were approximately dose-proportional from 2 mg to 1200 mg. Adverse events reported for MK-8507 were non-serious and mild in intensity. There were no trends in vital signs, electrocardiograms or safety laboratory tests. The most common adverse events were headache, cough, and rhinorrhea.

A Phase 1b open-label, proof of concept study was also conducted to evaluate the antiviral efficacy, pharmacokinetics, safety, and tolerability of single doses of 40 mg, 80 mg, and 600 mg of MK-8507 over seven to 14 days in 18 HIV-1 infected, antiretroviral-naïve adult males (six participants per dosing arm). Single doses of MK-8507 resulted in a reduction in viral load at seven days, comparable to other NNRTIs dosed daily for the same timeframe. At seven days post-dose, a mean (95% CI) viral load reduction of 1.22 (1.52, 0.91) log₁₀copies/mL at 40 mg, 1.50 (1.80, 1.19) log₁₀ copies/mL at 80 mg, and 1.53 (1.84, 1.23) log₁₀ copies/mL at 600 mg was observed among participants. The pharmacokinetics were similar to that observed in uninfected participants, with mean concentrations at seven days post-dose of 78.1, 214, and 1400 nM at the 40, 80 and 600 mg doses, respectively. Beginning at day 10, following a 600 mg dose, one participant experienced viral rebound with F227C, a NNRTI-associated resistant variant. All doses showed low rates of adverse events, and the most common adverse events (AEs) were nasopharyngitis (n=3) and headache (n=3). One serious AE of diffuse large B-cell lymphoma, not considered to be related to study drug, was reported.

The antiviral potency and human pharmacokinetics of MK-8507 are favorable to advancing MK-8507 to Phase 2 studies of once-weekly administration as part of combination antiretroviral therapy.

Selected Safety Information about PIFELTRO and DELSTRIGO

Warning: Posttreatment Acute Exacerbation of Hepatitis B (HBV)

All patients with HIV-1 should be tested for the presence of HBV before initiating ARV therapy. Severe acute exacerbations of HBV have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing lamivudine or tenofovir disoproxil fumarate (TDF), which are components of DELSTRIGO. Patients coinfected with HIV-1 and HBV who discontinue DELSTRIGO should be monitored with both clinical and laboratory follow-up for at least several months after stopping DELSTRIGO. If appropriate, initiation of anti-HBV therapy may be warranted.

PIFELTRO and DELSTRIGO are contraindicated when co-administered with drugs that are strong cytochrome P450 (CYP)3A enzyme inducers (including the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, and phenytoin; the androgen receptor inhibitor enzalutamide; the antimycobacterials rifampin and rifapentine; the cytotoxic agent mitotane; and the herbal product St. John’s wort (Hypericum perforatum)), as significant decreases in doravirine plasma concentrations may occur, which may decrease the effectiveness of DELSTRIGO and PIFELTRO.

DELSTRIGO is contraindicated in patients with a previous hypersensitivity reaction to lamivudine.

Renal impairment, including cases of acute renal failure and Fanconi syndrome, have been reported with the use of TDF. DELSTRIGO should be avoided with concurrent or recent use of a nephrotoxic agent (eg, high-dose or multiple NSAIDs). Cases of acute renal failure after initiation of high-dose or multiple NSAIDs have been reported in patients with risk factors for renal dysfunction who appeared stable on TDF.

Prior to or when initiating DELSTRIGO, and during treatment, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus. Discontinue DELSTRIGO in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Discontinue DELSTRIGO if estimated creatinine clearance declines below 50 mL/min.

In clinical trials in HIV-1 infected adults, TDF was associated with slightly greater decreases in bone mineral density (BMD) and increases in biochemical markers of bone metabolism. Serum parathyroid hormone levels and 1,25 Vitamin D levels were also higher. Cases of osteomalacia associated with proximal renal tubulopathy have been reported with the use of TDF.

Immune reconstitution syndrome can occur, including the occurrence of autoimmune disorders with variable time to onset, which may necessitate further evaluation and treatment.

Because DELSTRIGO is a complete regimen, co-administration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended.

Co-administration of PIFELTRO with efavirenz, etravirine, or nevirapine is not recommended.

If DELSTRIGO is co-administered with rifabutin, take one tablet of DELSTRIGO once daily, followed by one tablet of doravirine (PIFELTRO) approximately 12 hours after the dose of DELSTRIGO.

If PIFELTRO is co-administered with rifabutin, increase PIFELTRO dosage to one tablet twice daily (approximately 12 hours apart).

Consult the full Prescribing Information prior to and during treatment for more information on potential drug-drug interactions.

Because DELSTRIGO is a fixed-dose combination tablet and the dosage of lamivudine and TDF cannot be adjusted, DELSTRIGO is not recommended in patients with estimated creatinine clearance less than 50 mL/min.

The most common adverse reactions with DELSTRIGO (incidence ≥5%, all intensities) were dizziness (7%), nausea (5%), and abnormal dreams (5%). The most common adverse reactions with PIFELTRO (incidence ≥5%, all intensities) were nausea (7%), dizziness (7%), headache (6%), fatigue (6%), diarrhea (6%), abdominal pain (5%), and abnormal dreams (5%).

By Week 96 in DRIVE-FORWARD, 2% of adult subjects in the PIFELTRO group and 3% in the DRV+r group had adverse events leading to discontinuation of study medication.

By Week 96 in DRIVE-AHEAD, 3% of adult subjects in the DELSTRIGO group and 7% in the EFV/FTC/TDF group had adverse events leading to discontinuation of study medication.

In DRIVE-FORWARD, mean changes from baseline at Week 48 in LDL-cholesterol (LDL-C) and non-HDL-cholesterol (non-HDL-C) were pre-specified. LDL-C: -4.6 mg/dL in the PIFELTRO group vs 9.5 mg/dL in the DRV+r group. Non-HDL-C: -5.4 mg/dL in the PIFELTRO group vs 13.7 mg/dL in the DRV+r group. The clinical benefits of these findings have not been demonstrated.

In DRIVE-AHEAD, mean changes from baseline at Week 48 in LDL-cholesterol (LDL-C) and non-HDL-cholesterol (non-HDL-C) were pre-specified. LDL-C: -2.1 mg/dL in the DELSTRIGO group vs 8.3 mg/dL in the EFV/FTC/TDF group. Non-HDL-C: -4.1 mg/dL in the DELSTRIGO group vs 12.7 mg/dL in the EFV/FTC/TDF group. The clinical benefits of these findings have not been demonstrated.

In DRIVE-SHIFT, mean changes from baseline at Week 48 in LDL-cholesterol (LDL-C) and non-HDL-cholesterol (non-HDL-C) were pre-specified. LDL-C: -16.3 mg/dL in the DELSTRIGO group vs -2.6 mg/dL in the PI + ritonavir group. Non-HDL-C: -24.8 mg/dL DELSTRIGO group vs -2.1 mg/dL in the PI + ritonavir group. The clinical benefits of these findings have not been demonstrated.

In DRIVE-AHEAD, neuropsychiatric adverse events were reported in the three pre-specified categories of sleep disorders and disturbances, dizziness, and altered sensorium. Twelve percent of adult subjects in the DELSTRIGO group and 26% in the EFV/FTC/TDF group reported neuropsychiatric adverse events of sleep disorders and disturbances; 9% in the DELSTRIGO group and 37% in the EFV/FTC/TDF group reported dizziness; and 4% in the DELSTRIGO group and 8% in the EFV/FTC/TDF group reported altered sensorium.

The safety of DELSTRIGO in virologically-suppressed adults was based on Week 48 data from subjects in the DRIVE-SHIFT trial. Overall, the safety profile in virologically-suppressed adult subjects was similar to that in subjects with no ARV treatment history.

Serum ALT and AST Elevations: In the DRIVE-SHIFT trial, 22% and 16% of subjects in the immediate switch group experienced ALT and AST elevations greater than 1.25 X ULN, respectively, through 48 weeks on DELSTRIGO. For these ALT and AST elevations, no apparent patterns with regard to time to onset relative to switch were observed. One percent of subjects had ALT or AST elevations greater than 5 X ULN through 48 weeks on DELSTRIGO. The ALT and AST elevations were generally asymptomatic, and not associated with bilirubin elevations. In comparison, 4% and 4% of subjects in the delayed switch group experienced ALT and AST elevations of greater than 1.25 X ULN through 24 weeks on their baseline regimen.

Mothers infected with HIV-1 should be instructed not to breastfeed if they are receiving PIFELTRO or DELSTRIGO due to the potential for HIV-1 transmission.

About Islatravir (MK-8591)

Islatravir (formerly MK-8591) is Merck’s investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI) currently being evaluated in clinical trials for the treatment of HIV-1 infection in combination with other antiretrovirals, as well as for pre-exposure prophylaxis (PrEP) of HIV-1 infection as a single investigational agent, across a variety of formulations.

Our Commitment to HIV

For more than 30 years, Merck has been committed to scientific research and discovery in HIV, and we continue to be driven by the conviction that more medical advances are still to come. Our focus is on pursuing research that addresses unmet medical needs and helps people living with HIV and their communities. We remain committed to working hand-in-hand with our partners in the global HIV community to address the complex challenges that hinder continued progress.

Our Commitment to Infectious Diseases

For more than 100 years, Merck has contributed to the discovery and development of novel medicines and vaccines to combat infectious diseases. In addition to a combined portfolio of vaccines and antibacterial, antiviral and antifungal medicines, Merck has multiple programs that span discovery through late-stage development. To learn more about Merck’s infectious diseases pipeline, visit www.merck.com.

About Merck

For more than 125 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2019 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (https://www.sec.gov/).

Please see Prescribing Information for PIFELTRO (doravirine) at: https://www.merck.com/product/usa/pi_circulars/p/pifeltro/pifeltro_pi.pdf; and Patient Information for PIFELTRO (doravirine) at: https://www.merck.com/product/usa/pi_circulars/p/pifeltro/pifeltro_ppi.pdf

Please see Prescribing Information for DELSTRIGO (doravirine/3TC/TDF) at: https://www.merck.com/product/usa/pi_circulars/d/delstrigo/delstrigo_pi.pdf and Patient Information for DELSTRIGO (doravirine/3TC/TDF) at: https://www.merck.com/product/usa/pi_circulars/d/delstrigo/delstrigo_ppi.

Contacts

Media:

Pamela Eisele

(267) 305-3558

Sarra S. Herzog

(201) 669-6570

Investors:

Peter Dannenbaum

(908) 740-1037

Michael DeCarbo

(908) 740-1807

Read full story here

October 8, 2020

Tags #HIV-1, #Phase2b, #Virologic, #Week96, Doravirine, Islatravir, Merck, Merck#HIV-1

Healthcare

Opdivo (nivolumab) plus chemotherapy show statistically significant improvement in pathologic complete response as neoadjuvant treatment of resectable non-small cell lung cancer in phase 3 CheckMate-816 trial

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CheckMate –816 met a primary endpoint of improved pathologic complete response in patients who received Opdivo plus chemotherapy before surgery

Positive results mark the first time an immune checkpoint inhibitor-based combination has demonstrated superior efficacy versus chemotherapy as neoadjuvant therapy in a Phase 3 trial in resectable non-small cell lung cancer

Opdivo-based treatments have now shown benefit in four Phase 3 clinical trials in early-stage cancers, including lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma

PRINCETON, N.J.–(BUSINESS WIRE)–$BMY #BMS—Bristol Myers Squibb (NYSE: BMY) today announced that the Phase 3 CheckMate -816 trial met a primary endpoint of pathologic complete response (pCR) in resectable non-small cell lung cancer (NSCLC). In the trial, significantly more patients treated with Opdivo (nivolumab) plus chemotherapy before surgery showed no evidence of cancer cells in their resected tissue compared to those treated with chemotherapy alone. CheckMate -816 is the first and only Phase 3 trial to demonstrate a benefit with an immune checkpoint inhibitor in combination with chemotherapy as a neoadjuvant treatment in non-metastatic NSCLC.

Patients in the experimental arm of the trial received up to three doses of Opdivo plus chemotherapy prior to surgery, a standard number of cycles of therapy in the neoadjuvant setting. The safety profile of Opdivo plus chemotherapy was consistent with previously reported studies in NSCLC.

“Up to half of patients who undergo surgery for non-metastatic lung cancer will experience disease recurrence,” said Mark Awad, M.D., Ph.D., clinical director, Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute. “Nivolumab has shown benefit as an adjuvant, or post-surgical, treatment option in other cancer types, and the positive results from CheckMate -816 speak to its potential in the neoadjuvant setting of resectable non-small cell lung cancer. We look forward to following patients in this trial of nivolumab plus chemotherapy as a new way of treating resectable non-small cell lung cancer, with the potential that an improvement in pathologic complete response will lead to extended event-free survival and, ultimately, overall survival.”

“The CheckMate -816 results build on Bristol Myers Squibb’s heritage in the treatment of thoracic cancers, where Opdivo-based regimens have demonstrated superior overall survival in patients with metastatic non-small cell lung cancer and unresectable malignant pleural mesothelioma,” said Abderrahim Oukessou, M.D., vice president, thoracic cancers development lead, Bristol Myers Squibb. “In addition, these data add to our growing scientific understanding of the potential of immunotherapy approaches to transform outcomes in earlier stages of different cancer types, when the immune system may be more responsive. We’re grateful to the patients and investigators who participated in the CheckMate -816 trial.”

The company will complete a full evaluation of the available CheckMate -816 data, work with investigators to present the results at an upcoming medical conference and discuss potential regulatory options with health authorities. The CheckMate -816 trial is currently ongoing to assess the other primary endpoint of event-free survival (EFS), to which the company remains blinded, as well as key secondary endpoints.

In non-metastatic NSCLC, Bristol Myers Squibb and collaborators are exploring the use of immunotherapy in the neoadjuvant, adjuvant and peri-operative settings, as well as in association with chemoradiation. To date, Opdivo has shown improved efficacy in the neoadjuvant or adjuvant treatment of four tumor types: lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma.

About CheckMate -816

CheckMate -816 is a Phase 3 randomized, open label, multi-center trial evaluating Opdivo plus chemotherapy compared to chemotherapy alone as neoadjuvant treatment in patients with resectable non-small cell lung cancer. For the primary analysis, 358 patients were randomized to receive either Opdivo 360 mg plus histology-based platinum doublet chemotherapy every three weeks for up to three doses, or platinum doublet chemotherapy every three weeks for up to three doses, followed by surgery. The primary endpoints of the trial are pathologic complete response (pCR) and event-free survival. Key secondary endpoints include overall survival (OS), major pathologic response (MPR) and time to death or distant metastases.

About Lung Cancer

Lung cancer is the leading cause of cancer deaths globally. The two main types of lung cancer are non-small cell and small cell. Non-small cell lung cancer (NSCLC) is one of the most common types of lung cancer, representing up to 84% of diagnoses. Non-metastatic cases account for the majority of NSCLC diagnoses (approximately 60%). While many non-metastatic NSCLC patients are cured by surgery, 30% to 55% develop recurrence and die of their disease despite resection, contributing to a need for treatment options administered before surgery (neoadjuvant) and/or after surgery (adjuvant) to improve long-term outcomes.

Bristol Myers Squibb: Advancing Cancer Research

At Bristol Myers Squibb, patients are at the center of everything we do. The goal of our cancer research is to increase patients’ quality of life, long-term survival and make cure a possibility. We harness our deep scientific experience, cutting-edge technologies and discovery platforms to discover, develop and deliver novel treatments for patients.

Building upon our transformative work and legacy in hematology and Immuno-Oncology that has changed survival expectations for many cancers, our researchers are advancing a deep and diverse pipeline across multiple modalities. In the field of immune cell therapy, this includes registrational CAR T cell agents for numerous diseases, and a growing early-stage pipeline that expands cell and gene therapy targets, and technologies. We are developing cancer treatments directed at key biological pathways using our protein homeostasis platform, a research capability that has been the basis of our approved therapies for multiple myeloma and several promising compounds in early- to mid-stage development. Our scientists are targeting different immune system pathways to address interactions between tumors, the microenvironment and the immune system to further expand upon the progress we have made and help more patients respond to treatment. Combining these approaches is key to delivering potential new options for the treatment of cancer and addressing the growing issue of resistance to immunotherapy. We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines a reality for patients.

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.

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) is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with progression after platinum-based chemotherapy and at least one other line of therapy. 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 first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).

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

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

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. 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.

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) 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), 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.

IMPORTANT SAFETY INFORMATION

Severe and Fatal Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions listed herein may not be inclusive of 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 at any time after starting or discontinuing YERVOY. Early identification and management are essential to ensure safe use of 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 before each dose. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue YERVOY depending on severity. In general, if YERVOY requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less followed by corticosteroid taper for at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reaction is not controlled with corticosteroid therapy. Institute hormone replacement therapy for endocrinopathies as warranted.

Immune-Mediated Pneumonitis

OPDIVO can cause immune-mediated pneumonitis. Fatal cases have been reported. Monitor patients for signs with radiographic imaging and for symptoms of pneumonitis. Administer corticosteroids for Grade 2 or more severe pneumonitis. Permanently discontinue for Grade 3 or 4 and withhold until resolution for Grade 2. In patients receiving OPDIVO monotherapy, fatal cases of immune-mediated pneumonitis have occurred. Immune-mediated pneumonitis occurred in 3.1% (61/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated pneumonitis occurred in 6% (25/407) of patients. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated pneumonitis occurred in 10% (5/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated pneumonitis occurred in 4.4% (24/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated pneumonitis occurred in 1.7% (2/119) of patients. In NSCLC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated pneumonitis occurred in 9% (50/576) of patients, including Grade 4 (0.5%), Grade 3 (3.5%), and Grade 2 (4.0%) immune-mediated pneumonitis. Four patients (0.7%) died due to pneumonitis. The incidence and severity of immune-mediated pneumonitis in patients with NSCLC treated with OPDIVO 360 mg every 3 weeks in combination with YERVOY 1 mg/kg every 6 weeks and 2 cycles of platinum-doublet chemotherapy were comparable to treatment with OPDIVO in combination with YERVOY only. The incidence and severity of immune-mediated pneumonitis in patients with malignant pleural mesothelioma treated with OPDIVO 3 mg/kg every 2 weeks with YERVOY 1 mg/kg every 6 weeks were similar to those occurring in NSCLC.

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: Grade 3 (n=1) and Grade 2 (n=12).

Immune-Mediated Colitis

OPDIVO can cause immune-mediated colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 (of more than 5 days duration), 3, or 4 colitis. Withhold OPDIVO monotherapy for Grade 2 or 3 and permanently discontinue for Grade 4 or recurrent colitis upon re-initiation of OPDIVO. When administered with YERVOY, withhold OPDIVO and YERVOY for Grade 2 and permanently discontinue for Grade 3 or 4 or recurrent colitis. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated colitis occurred in 26% (107/407) of patients including three fatal cases. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated colitis occurred in 10% (5/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated colitis occurred in 10% (52/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated colitis occurred in 7% (8/119) of patients.

In a separate Phase 3 trial of YERVOY 3 mg/kg, immune-mediated diarrhea/colitis occurred in 12% (62/511) of patients, including Grade 3-5 (7%).

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. Addition of an alternative immunosuppressive agent to the corticosteroid therapy, or replacement of the corticosteroid therapy, should be considered in corticosteroid-refractory immune-mediated colitis if other causes are excluded.

Immune-Mediated Hepatitis

OPDIVO can cause immune-mediated hepatitis. Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater transaminase elevations. For patients without HCC, withhold OPDIVO for Grade 2 and permanently discontinue OPDIVO for Grade 3 or 4. For patients with HCC, withhold OPDIVO and administer corticosteroids if AST/ALT is within normal limits at baseline and increases to >3 and up to 5 times the upper limit of normal (ULN), if AST/ALT is >1 and up to 3 times ULN at baseline and increases to >5 and up to 10 times the ULN, and if AST/ALT is >3 and up to 5 times ULN at baseline and increases to >8 and up to 10 times the ULN. Permanently discontinue OPDIVO and administer corticosteroids if AST or ALT increases to >10 times the ULN or total bilirubin increases >3 times the ULN. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated hepatitis occurred in 13% (51/407) of patients. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated hepatitis occurred in 20% (10/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated hepatitis occurred in 7% (38/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated hepatitis occurred in 8% (10/119) of patients.

In Checkmate 040, immune-mediated hepatitis requiring systemic corticosteroids occurred in 5% (8/154) of patients receiving OPDIVO.

In a separate Phase 3 trial of YERVOY 3 mg/kg, immune-mediated hepatitis occurred in 4.1% (21/511) of patients, including Grade 3-5 (1.6%).

Immune-Mediated Endocrinopathies

OPDIVO can cause immune-mediated hypophysitis, immune-mediated adrenal insufficiency, autoimmune thyroid disorders, and Type 1 diabetes mellitus. Monitor patients for signs and symptoms of hypophysitis, signs and symptoms of adrenal insufficiency, thyroid function prior to and periodically during treatment, and hyperglycemia. Withhold for Grades 2, 3, or 4 endocrinopathies if not clinically stable. Administer hormone replacement as clinically indicated and corticosteroids for Grade 2 or greater hypophysitis. Withhold for Grade 2 or 3 and permanently discontinue for Grade 4 hypophysitis. Administer corticosteroids for Grade 3 or 4 adrenal insufficiency. Withhold for Grade 2 and permanently discontinue for Grade 3 or 4 adrenal insufficiency. Administer hormone-replacement therapy for hypothyroidism. Initiate medical management for control of hyperthyroidism. Withhold OPDIVO for Grade 3 and permanently discontinue for Grade 4 hyperglycemia.

In patients receiving OPDIVO monotherapy, hypophysitis occurred in 0.6% (12/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, hypophysitis occurred in 9% (36/407) of patients. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, hypophysitis occurred in 4% (2/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, hypophysitis occurred in 4.6% (25/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated hypophysitis occurred in 3.4% (4/119) of patients. In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, adrenal insufficiency occurred in 5% (21/407) of patients. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, adrenal insufficiency occurred in 18% (9/49) of patients.

Contacts

Bristol Myers Squibb
Media Inquiries:
Media@BMS.com
609-252-3345

Investors:
Tim Power

609-252-7509

timothy.power@bms.com

Read full story here

October 7, 2020

Tags Cancer, Chemotherapy, Lung, Nivolumab, Opdivo, patients, patientsCancer

Healthcare

Topcon achieves #1 market position in OCT devices

Post author By Michelle Dryden
Post date October 6, 2020
No Comments on Topcon achieves #1 market position in OCT devices

Leads the OCT Market with Innovative Multimodal Technology

OAKLAND, N.J.–(BUSINESS WIRE)–#OCT–Topcon Healthcare, a leading provider of medical devices and software solutions for the global eye care community, announced today that it has achieved the #1 position in the global OCT market, as reported by Market Scope’s 2020 Ophthalmic Diagnostic Equipment Market Report.

Topcon leads the global market in the OCT segment with a 27.9 percent share. Its lineup of instruments includes the versatile Maestro2 Robotic OCT and the Triton Swept Source OCT. Both devices combine fundus and OCT functionality in an easy-to-use platform.

“The Maestro2 and the Triton are engineered to help ECP’s answer complex clinical questions quickly, easily, and confidently. By delivering multiple images and data points with one click of a button in a format that is easy to understand and interpret, the Maestro2 and Triton meet the demands of today’s busy practitioners. We are thrilled at the way the market has embraced this technology,” stated Greg Hoffmeyer, Director of OCT Clinical Sales for Topcon Healthcare.

“We are very pleased to have achieved the #1 market position in OCT devices. Our team has been hard at work leveraging the latest technology to develop versatile OCT devices that enhance practice workflow and provide exceptional clinical utility. The Market Scope recognition is confirmation that our devices are being well received by ECPs and are meeting their clinical needs,” summarized John Trefethen, Global VP of Marketing & Product Design for Topcon Healthcare.

About Topcon Healthcare

Topcon Healthcare sees eye health differently. Our vision is to empower providers with smart and efficient technologies for enhanced patient care. Keeping pace with the ever-changing landscape of the healthcare industry, we offer the latest integrated solutions, including advanced multimodal imaging, vendor-neutral data management, and ground-breaking remote diagnostic technology.

A globally-oriented business, Topcon is focused on developing solutions towards solving societal challenges in the mega-domains of healthcare, agriculture, and infrastructure. In healthcare, these challenges include increasing eye disease, rising medical costs, access to healthcare, and physician shortages. By investing in value-driven innovations, Topcon works to enable people to enjoy good health and high quality of life.

Contacts

John Trefethen, MFA

Global Vice President, Marketing & Product Design Topcon Healthcare

E-mail: jtrefethen@topcon.com

, , {item content}, October 6, 2020

Tags #Eyecare, #OCT, #Optical, devices, Topcon, Topcon#Eyecare

Healthcare

Dr. Reddy’s Laboratories announces the launch of a generic version of Sapropterin Dihydrochloride tablets for oral use in the U.S. Market

“We are pleased to launch this generic version of Sapropterin Dihydrochloride Tablets, for Oral Use, illustrating our continued commitment to bring affordable generic medicines to market for patients,” says Marc Kikuchi, Chief Executive Officer, North America Generics, Dr. Reddy’s Laboratories. “At the same time, this product demonstrates that we are actively expanding the breadth of our portfolio with a treatment for a rare disease. We are pleased to provide financial support to patients by offering a co-pay card program for eligible patients, details will be available on our website.”

Dr. Reddy’s Sapropterin Dihydrochloride Tablets, 100 mg are available in bottle count sizes of 120.

Please see full prescribing information.

https://www.drreddys.com/pi/sapropterin-tabs.pdf

RDY-0920-317

About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses – Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddy’s operates in markets across the globe. Our major markets include – USA, India, Russia & CIS countries, and Europe. For more information, log on to: www.drreddys.com

Disclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management’s current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words “may”, “will”, “should”, “expects”, “plans”, “intends”, “anticipates”, “believes”, “estimates”, “predicts”, “potential”, or “continue” and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults, currency exchange rates, interest rates, persistency levels and frequency / severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization, including related integration issues, and (vi) the susceptibility of our industry and the markets addressed by our, and our customers’, products and services to economic downturns as a result of natural disasters, epidemics, pandemics or other widespread illness, including coronavirus (or COVID-19), and (vii) other risks and uncertainties identified in our public filings with the Securities and Exchange Commission, including those listed under the “Risk Factors” and “Forward-Looking Statements” sections of our Annual Report on Form 20-F for the year ended March 31, 2020. The company assumes no obligation to update any information contained herein.”

Contacts

INVESTOR RELATIONS
AMIT AGARWAL

amita@drreddys.com
(PH: +91-40-49002135)

MEDIA RELATIONS
APARNA TEKURI

aparnatekuri@drreddys.com
(PH: +91-40-49002446)

, , {item content}, October 3, 2020

Tags #Launch, #Oral, #Sapropterin Dihydrochloride Tablets, Dr. Reddy Laboratories, Generic, patients, Product, Product#Launch

Healthcare

Merck to present new data from the company’s diverse HIV portfolio and pipeline at HIV Glasgow 2020

Post author By Michelle Dryden
Post date October 1, 2020
No Comments on Merck to present new data from the company’s diverse HIV portfolio and pipeline at HIV Glasgow 2020

Researchers Will Present Week 96 Data from Phase 2b Study Evaluating Islatravir in Combination with Doravirine, and Phase 1/1b Data for MK-8507, an Investigational NNRTI for the Treatment of HIV-1 Infection

Company Plans to Advance MK-8507 into Phase 2 Evaluating its Efficacy and Safety in Combination with Islatravir as a Once-Weekly Oral Regimen

KENILWORTH, N.J.–(BUSINESS WIRE)–$MRK #MRK–Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that nine abstracts from the company’s diverse HIV portfolio and pipeline will be presented at the 2020 International Congress on Drug Therapy in HIV Infection (HIV Glasgow 2020, October 5-8, 2020). During the congress, researchers will present new data from Merck’s HIV development program, including 96-week results from efficacy and safety analyses from the Phase 2b study of islatravir (Merck’s investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI)) in combination with doravirine (PIFELTRO™) in adults with HIV-1 infection who had not previously received antiretroviral treatment. Additionally, Merck will share results from Phase 1/1b studies of MK-8507, an investigational oral non-nucleoside reverse transcriptase inhibitor (NNRTI) under development for once-weekly oral administration in combination with islatravir. These and other data, including 144-week results from the Phase 3 DRIVE-SHIFT study evaluating the effect of switching from a stable antiretroviral therapy (ART) regimen to DELSTRIGO™ (doravirine/lamivudine/tenofovir disoproxil fumarate), will be shared via oral and poster presentations during the virtual congress.

“Merck remains at the forefront of research to develop new medicines for people living with HIV. The new data we will present at HIV Glasgow 2020 from our HIV research programs – for doravirine, islatravir, and now MK-8507 – demonstrate our sustained innovation and unwavering commitment to help address the global burden of HIV,” said Dr. Joan Butterton, vice president, infectious diseases, Global Clinical Development, Merck Research Laboratories. “Our plans to evaluate MK-8507 as a potential partner with islatravir, as well as the ongoing clinical trials of islatravir and doravirine, illustrate the diversity of candidates in our HIV pipeline and our quest to transform the way HIV is treated.”

Select abstracts in the HIV Glasgow 2020 program include:

Islatravir in combination with doravirine maintains HIV-1 viral suppression through 96 weeks. Oral Presentation O415. Abstract 4913173. J.M. Molina et al.
Renal safety through 96 weeks from a phase 2 trial (P011) of islatravir and doravirine in treatment-naïve adults with HIV-1. Poster Presentation P048. Abstract 4919993. F. Post et al.
Analysis of protocol defined virologic failure through 96 weeks from a phase 2 trial (P011) of islatravir and doravirine in treatment-naïve adults with HIV-1. Poster Presentation P047. Abstract 4913025. C. Orkin et al.
Long-term treatment safety and efficacy following switch to doravirine/lamivudine/tenofovir disoproxil fumarate (DOR/3TC/TDF): Week 144 results of the DRIVE-SHIFT trial. Poster Presentation P037. Abstract 4922614. P. Kumar et al.
Single doses of MK-8507, a novel HIV-1 NNRTI, reduced HIV viral load for at least a week. Oral Presentation O416. W. Ankrom et al.
Safety, tolerability and pharmacokinetics following single- and multiple-dose administration of the novel NNRTI MK-8507 with a midazolam interaction arm. Poster Presentation P099. Abstract 4913210. W. Ankrom et al.
Islatravir Selects for HIV-1 Variants in MT4-GFP cells that Profoundly Reduce Replicative Capacity in PBMCs and Reduce Susceptibility to Islatravir but not NRTIs. Poster Presentation P120. Abstract 4920686. T. Diamond et al.

For more information, including details around the virtual programming, please visit the HIV Glasgow 2020 website.

Indications and Usage for PIFELTRO and DELSTRIGO

PIFELTRO is indicated in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in adult patients with no prior ARV treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable ARV regimen with no history of treatment failure and no known substitutions associated with resistance to doravirine.

DELSTRIGO is indicated as a complete regimen for the treatment of HIV-1 infection in adult patients with no prior ARV treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable ARV regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of DELSTRIGO.

Selected Safety Information about PIFELTRO and DELSTRIGO

Warning: Posttreatment Acute Exacerbation of Hepatitis B (HBV)

DELSTRIGO is contraindicated in patients with a previous hypersensitivity reaction to lamivudine.

Renal impairment, including cases of acute renal failure and Fanconi syndrome, have been reported with the use of TDF. DELSTRIGO should be avoided with concurrent or recent use of a nephrotoxic agent (e.g., high-dose or multiple NSAIDs). Cases of acute renal failure after initiation of high-dose or multiple NSAIDs have been reported in patients with risk factors for renal dysfunction who appeared stable on TDF.