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

 
• By Emily Hayes
  
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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study in first-line lung cancer to include dual endpoints of progression-free-survival and overall survival, and has withdrawn a filing for the combination in Europe based on mid-stage data.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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