Almost three years after whiffing in a confirmatory study, Merck touts new data for Keytruda in HCC

Keytruda’s accelerated approval in a common form of liver cancer looked shaky after the drug failed on two survival measures in a confirmatory study almost three years ago. Now Merck’s touting what could be a confirmatory win — but will three patient deaths mar its chances?

A regimen of Keytruda plus best standard-of-care reduced patients’ risk of death by 21% compared to placebo plus standard of care (p=0.0180), meeting the primary endpoint in the Phase III KEYNOTE-394 study, Merck announced on Tuesday. The trial enrolled 453 Asian patients with advanced hepatocellular carcinoma (HCC), who had previously been treated with sorafenib or oxaliplatin-based chemotherapy.