Merck: Phase 3 Trial With KEYTRUDA Meets Endpoint In Patients With Advanced Hepatocellular Carcinoma

Merck (MRK) said the phase 3 KEYNOTE-394 trial investigating KEYTRUDA in Asian patients with advanced hepatocellular carcinoma previously treated with sorafenib met its primary endpoint of overall survival. In the study, treatment with KEYTRUDA plus best supportive care resulted in a statistically significant improvement in overall survival compared with placebo plus best supportive care. No new safety signals were observed, the company said.

KEYTRUDA was granted accelerated approval in 2018 for the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib. KEYNOTE-394 was considered as a potential confirmatory trial that could verify the clinical benefit of KEYTRUDA for these patients.

Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories, said: "It is very encouraging that KEYTRUDA significantly improved overall survival in this study, and we look forward to engaging with regulatory authorities as quickly as possible."

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