Merck said topline Phase 3 results show an injectable version of Keytruda met the main goal of non-inferiority compared to the intravenously infused formulation that is the pharma giant’s top-selling product. Injectable Keytruda could help Merck compete against coming competition from biosimilars.
In a media briefing during the J.P. Morgan Healthcare Conference in San Francisco, Paul Hudson said unlike Sanofi, large pharma companies with top-selling drugs have a portfolio akin to a leaky bathtub because in a few years, they will have to replace much of that revenue as drug patents expire.
The future looks bright for the integrated specialty pharmacy model – for health systems, providers, and most importantly, for patients.
FDA approval of a therapy that pairs drugs from Eisai and Merck allows the combination to become a first-line treatment for renal cell carcinoma. It’s the latest approval for the partners, which have been working together since 2018.
The deal will broaden Merck's oncology portfolio as it picks up an antibody-drug conjugate, a class of biological drugs that target tumor cells even as the pharma giant jettisons other parts of its business
The FDA approved Keytruda as a single agent for patients with first-line metastatic or unresectable colorectal cancer that carries the biomarker MSI-H or dMMR. The drug was the first to win a biomarker-based, tumor-agnostic label, in 2017.
The company said Imfinzi and chemotherapy, with or without tremelimumab, extended progression-free survival in first-line non-small cell lung cancer versus chemotherapy, setting up Imfinzi as a potential competitor to Merck's Keytruda. Overall survival data are expected next year.
Closing cancer health equity gaps require medical breakthroughs made possible by new funding approaches.
Drug regulators in the U.S., Canada and Australia simultaneously approved Merck's Keytruda and Eisai's Lenvima for advanced endometrial carcinoma following a collaborative review under a program called Project Orbis.
The study, by Personal Genome Diagnostics and academic researchers, was able to predict responses to checkpoint inhibitor therapy in patients with MSI-H and high tumor mutational burden.
The company also advanced a therapy, a personalized cancer vaccine in melanoma, into a Phase II study as the first patient in the trial consented.
The study, by US and Korean researchers, found Guardant360's detection of MSI-H/dMMR "highly concordant" with that of standard tissue biopsy, including in a subset of gastric cancer patients who responded to immunotherapy.
Hear executives from Quantum Health, Surescripts, EY, Clinical Architecture and Personify Health share their views on digital transformation in healthcare.
The KEYNOTE-119 study failed to show a survival benefit in TNBC patients. The news comes two months after the FDA gave accelerated approval to a rival, Roche's Tecentriq.
The company said it had shared data from the Phase III study with the FDA. However, per FDA regulations, there is a risk that the accelerated approval for hepatocellular carcinoma could be withdrawn.
Two drugs - Pfizer and Merck KGaA's Bavencio and AstraZeneca's Imfinzi - saw Phase III trials fail, while anticipated negative results prompted Roche to withdraw Tecentriq from regulatory review.
Kyoto University's Tasuku Honjo and MD Anderson's James Allison will share the prize for work that led to immunotherapy drugs like Keytruda and Yervoy.
Merck's Keytruda marks the second label expansion, after Novartis' Kisqali, under Real-Time Oncology Review program.