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Merck Stresses Overall Survival In Keytruda/Chemo '189 Trial Revamp

 
• By Emily Hayes

Merck is changing the statistical analysis of combination study in first-line lung cancer to include dual endpoints of progression-free-survival and overall survival, and has withdrawn a filing for the combination in Europe based on mid-stage data.

Malignant effusion: Pleural fluid cytology of lung (pulmonary) adenocarcinoma, a type of non small cell carcinoma.

Any change to the design of the immuno-oncology combination trials in lung cancer attracts enormous attention. Just one day after Bristol-Myers Squibb Co. was grilled over the CheckMate 227 study of its PD-1 inhibitor Opdivo (nivolumab) with the CTLA-4 inhibitor Yervoy in non-small cell lung cancer, Merck & Co. Inc. came under fierce questioning as it announced a delay and endpoint change to the eagerly awaited KEYNOTE-189 study of its PD-1 inhibitor Keytruda (pembrolizumab) with chemotherapy in first-line NSCLC.

For Bristol, CheckMate 227 is its final big shot at the first-line non-small cell lung cancer market, and investors and...

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More from Immuno-oncology

Zydus Looks To Ride gIbrance Exclusivity Wave; GLP-1 Battle-Ready With Differentiated Pen

 
• By Vibha Ravi

Ibrance is losing share to other drugs, but Zydus looks forward to a late 2027/early 2028 launch of its generic in the US where partner Synthon might have 180-day exclusivity. In India, as Lilly launches Mounjaro KwikPen, it hopes for a GLP-1 edge with a differentiated device and formulation.

Pfizer/Astellas’s Padcev Scores First Big Win In Bladder Cancer Study

 
• By Alaric DeArment

The drug, combined with Merck’s Keytruda, was successful among certain chemotherapy-ineligible MIBC patients, with another Phase III readout expected by March 2026.

Genmab/AbbVie’s Epkinly Likely To See Label Expansion After Phase III Win

 
• By Alaric DeArment

The FDA is expected to rule on the anti-CD20xCD3 bispecific combined with rituximab/lenalidomide in second-line follicular lymphoma in November.

Aurigene Oncology CEO On Biotech Valuations, CAR-Ts And Reimbursement Models

 
• By Anju Ghangurde

Aurigene Oncology CEO talks in this audio interview about the tough biotech funding environment, pipeline assets including a CAR-T therapy in Phase II, "hybrid" manufacturing, outcome-based reimbursement and the promise of bispecifics and multispecifics, including Akeso's PD-1/VEGF bispecific.

More from Anticancer

Boehringer Scores First Approval For Targeted Oral Drug In HER2-Mutant NSCLC

 
• By Alaric DeArment

The US FDA approved Hernexeos for previously treated HER2-mutant NSCLC, making it the first oral option in a setting where drugs like AstraZeneca/Daiichi Sankyo’s Enhertu dominate.

Genmab/AbbVie’s Epkinly Likely To See Label Expansion After Phase III Win

 
• By Alaric DeArment

The FDA is expected to rule on the anti-CD20xCD3 bispecific combined with rituximab/lenalidomide in second-line follicular lymphoma in November.

Sanofi’s Sarclisa Wins Another EU Multiple Myeloma Nod In Its Unequal Battle With J&J’s Darzalex

 
• By Sushmita Panda

The French drugmaker's anti-CD38 antibody has racked up another approval in first-line multiple myeloma, but it marks a small victory while the company develops a subcutaneous version to help level the field with J&J’s Darzalex.