Keytruda misses survival endpoints in Phase III HCC trial

Merck & Co. Inc. (NYSE:MRK) said Keytruda pembrolizumab missed the co-primary endpoints of improving overall survival (OS) and progression-free survival (PFS) in the Phase III KEYNOTE-240 trial to treat advanced hepatocellular carcinoma. Merck declined to disclose if KEYNOTE-240 was an FDA-required confirmatory trial which would enable Keytruda to keep its approval status for the indication.

In November 2018, FDA granted the anti-PD-1 mAb accelerated approval to treat HCC in patients previously treated with Nexavar sorafenib based on the Phase II KEYNOTE-224 trial. FDA said in its accelerated approval letter that Merck is to conduct one or more randomized trials that demonstrate an improvement in OS or a "large improvement" in PFS in patients with locally advanced, unresectable or metastatic HCC, with a final report submission due to the agency by October...