FDA warning of deaths in KEYNOTE 361 and IMvigor 130 studies of patients with bladder cancer taking Keytruda or Tecentriq monotherapy. Merck Inc.and Genentech /Roche.
The FDA on 25 May warned oncologists and clinical trial investigators of early signs from two trials that some bladder cancer patients treated first with either Keytruda or Tecentriq alone were dying sooner than those given platinum-based chemotherapy. Reviews by data monitoring committees overseeing Merck's KEYNOTE-361 and Roche's IMvigor130 observed decreased survival in the monotherapy arm of each study among patients whose tumors expressed low levels of PD-L1, a biomarker associated with response to immunotherapy. In an emailed statement, Merck said it had halted enrollment into the monotherapy arm of patients with low PD-L1 expression, but noted the study remains ongoing and no new safety concerns have yet been raised. Roche did not return a request for comment before publication.
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