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Merck and Gilead Halt Phase 3 NSCLC Trial of Trodelvy with Keytruda After DMC Review
business1 month ago

Merck and Gilead Halt Phase 3 NSCLC Trial of Trodelvy with Keytruda After DMC Review

Merck and Gilead announced the discontinuation of the Phase 3 KEYNOTE-D46/EVOKE-03 trial evaluating Trodelvy in combination with Keytruda for previously untreated metastatic NSCLC with PD-L1 TPS ≥50% after the external Data Monitoring Committee reviewed the final PFS data and interim OS analysis. While progression-free survival improved numerically, it did not reach statistical significance, and the likelihood of a statistically significant overall survival result at the planned final analysis is low. Safety was consistent with the known profiles of both drugs. Regulators were informed, investigators and patients advised to discuss treatment with physicians, and there are no changes to ongoing Trodelvy or Merck studies. Data will be presented at a future medical meeting.

via Merck.com|
#business#gilead#keytruda
Merck’s IDVYNSO earns FDA nod as a once-daily, two-drug HIV regimen
health2 months ago

Merck’s IDVYNSO earns FDA nod as a once-daily, two-drug HIV regimen

FDA approved IDVYNSO, a once-daily two-drug regimen (doravirine/islatravir) for adults with virologically suppressed HIV-1, intended to replace their current antiretroviral therapy. It is the first non-INSTI, tenofovir-free two-drug therapy to demonstrate non-inferiority to a three-drug regimen in two Phase 3 trials (052 vs BIKTARVY and 051 vs baseline ART). The product will be available in pharmacies after May 11 and carries contraindications with strong CYP3A inducers and with lamivudine or emtricitabine, plus safety considerations including potential severe skin reactions and drug interactions. Trials enrolled 708 participants with diverse demographics, supporting another option in HIV treatment.

via Merck.com|
#fda-approval#health#hiv
Merck's PD-1xVEGF bispecific MK-2010 shows early NSCLC signals in China trial
business2 months ago

Merck's PD-1xVEGF bispecific MK-2010 shows early NSCLC signals in China trial

Merck reported first clinical data from its PD-1xVEGF bispecific MK-2010 in a Chinese phase 1/2 NSCLC trial, showing unconfirmed ORRs of 55% in treatment-naïve PD-L1-positive patients at 20 mg/kg every three weeks and 44% at 30 mg/kg, with lower responses in previously treated patients. Across backfill cohorts (n=72) the safety profile included dose-limiting toxicities like grade 3 proteinuria and hemoptysis, several bleeding events, and deaths in higher-dose arms, though the maximum tolerated dose has not been reached. Results are early, from small cohorts, and Merck has not disclosed phase 3 plans, as rivals advance multiple PD-(L)1xVEGF programs; more data are needed to define MK-2010's potential role.

via Fierce Biotech|
#business#clinical-trial#immunotherapy
Keytruda's fortress: Merck's patent-and-pricing empire under global scrutiny
business2 months ago

Keytruda's fortress: Merck's patent-and-pricing empire under global scrutiny

An ICIJ investigation shows Merck’s Keytruda has become one of the world’s best-selling drugs not just because of therapeutic value but due to an expansive patent portfolio (more than 1,200 filings in 53 countries), lobbying, and pricing tactics that raise costs for patients worldwide while governments and insurers struggle to fund access; the report details price disparities, secrecy, accelerated approvals, and strategic moves like drug-dosing and product hopping that help Merck extend monopoly into the 2030s, with patients in India, Guatemala, the U.S. and elsewhere paying vast out-of-pocket or facing restricted access.

via International Consortium of Investigative Journalists - ICIJ|
#access-to-medicine#business#drug-pricing
Merck to buy Terns to accelerate CML program with allosteric inhibitor TERN-701
business3 months ago

Merck to buy Terns to accelerate CML program with allosteric inhibitor TERN-701

Merck will acquire Terns Pharmaceuticals for about $6.7 billion in cash, expanding its hematology portfolio with TERN-701, an oral allosteric BCR-ABL1 inhibitor in Phase 1/2 for Philadelphia chromosome-positive chronic myeloid leukemia (CML). The transaction, approved by both boards, is expected to close in the second quarter of 2026 and will be accounted as an asset acquisition with an approximate $5.8 billion impact on 2026 GAAP/non-GAAP results. TERN-701 has shown encouraging early activity and carries FDA Orphan Drug Designation from 2024, underscoring its potential as a differentiated CML therapy.

via Merck.com|
#business#cml#hematology
Merck Restructures to Stand Up a Dedicated Oncology Unit Ahead of Keytruda's Patent Cliff
business4 months ago

Merck Restructures to Stand Up a Dedicated Oncology Unit Ahead of Keytruda's Patent Cliff

Merck is splitting its human health business into two divisions—a dedicated oncology unit to oversee cancer therapies (including Keytruda) and a separate specialty pharma and infectious diseases unit for non-cancer products and vaccines—part of a strategy to sharpen growth after Keytruda's looming patent cliff. The company cites expectations of continued leadership in oncology and potential multi-brand growth, highlighting leadership changes: Jannie Oosthuizen will run the oncology and international unit, while Brian Foard heads the new specialty/pharma/infectious diseases unit, with Chirfi Guindo in a policy/communications role. Merck aims to sustain long-term oncology leadership and push growth through its pipeline, with executives signaling potential of more than $70B in annual revenue mid-decade.

via Fierce Pharma|
#business#corporate-reorganization#keytruda
business4 months ago

Merck Restructures Human Health to Accelerate Launches Across a Diversified Portfolio

Merck is reorganizing its Human Health unit into two business units—Oncology and Specialty, Pharma & Infectious Diseases—to sharpen commercial execution for a broader portfolio. New leaders Jannie Oosthuizen (Oncology) and Brian Foard (Specialty, Pharma & Infectious Diseases) will report to CEO Robert Davis, while Chirfi Guindo leads Strategic Access, Policy & Communications. The move aims to better advance Merck’s widening pipeline, with about 80 Phase 3 trials and more than 20 growth drivers anticipated in the coming years.

via Merck.com|
#business#human-health#infectious-diseases
Merck reshapes structure to create dedicated cancer unit led by Keytruda
business4 months ago

Merck reshapes structure to create dedicated cancer unit led by Keytruda

Merck will split its human-health business into two units: a cancer-focused division led by Keytruda and a separate non-oncology medicines arm, as the company diversifies ahead of Keytruda’s looming loss of exclusivity. Keytruda remains the world’s top-selling drug, with more than $30 billion in revenue in 2025, accounting for about half of Merck’s total revenue. Shares rose about 1.4% in premarket trading. Merck has expanded its pipeline and made major acquisitions to bolster growth, and appointed Jannie Oosthuizen to lead the new cancer unit.

via CNBC|
#business#cancer#corporate-split
Merck walks away from Revolution Medicines deal over valuation gap
business5 months ago

Merck walks away from Revolution Medicines deal over valuation gap

Merck ended discussions to acquire Revolution Medicines due to a valuation disagreement, effectively halting the deal. Investor interest in Revolution’s cancer-drug pipeline remains buoyant ahead of several key clinical trial results later this year, with Mizuho Securities estimating Revolution’s pancreatic cancer drug could reach about $10 billion in annual global sales by 2035 if the trials prove successful and safe.

via Seeking Alpha|
#acquisition#biotech#business