Keytruda fails confirmatory trial, but Merck says FDA will not pull approval

26 July 2017

In a setback for the company’s blockbuster immuno-oncology therapy, America’s Merck & Co (NYSE: MRK) announced the pivotal KEYNOTE-040 Keytruda (pembrolizumab) trial did not meet its primary endpoint of overall survival.

It’s the second piece of bad news for the program this month, following the US FDA’s decision to place a clinical hold on three studies exploring the anti-PD-1 drug as a combination therapy in multiple myeloma.

Shares in the company fell about half a percentage point following the news.

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