FDA details deaths that led to Keytruda MM trial holds

FDA released a public notice detailing mortality data that led the agency to place full clinical holds on two Phase III trials of Keytruda pembrolizumab plus immunomodulatory agents to treat multiple myeloma. In July, Merck & Co. Inc. (NYSE:MRK) announced FDA placed the KEYNOTE-183 and KEYNOTE-185 studies on hold following reports of a higher proportion of deaths in patients treated with the PD-1 inhibitor compared to controls. The drug is not approved for the indication.

KEYNOTE-183 is evaluating Keytruda plus dexamethasone and Pomalyst pomalidomide in a third-line setting, while KEYNOTE-185 is evaluating Keytruda plus dexamethasone and Revlimid lenalidomide as first-line treatment...