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

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 analysts on the firm's Oct. 26 earnings call were keen to understand whether Bristol could use the emerging tumor mutation burden biomarker to help find responders. Bristol execs declined to comment on whether the statistical plan for CheckMate 227 has been altered