Merck's Keytruda Tops Placebo On Overall Survival Endpoint In Liver Cancer Patients
- Merck & Co Inc (NYSE: MRK) has announced topline data from Phase 3 KEYNOTE-394 trial of Keytruda in Asian patients with advanced hepatocellular carcinoma (HCC).
- The trial included HCC patients previously treated with sorafenib.
- The study met its primary endpoint of overall survival (OS), and Keytruda plus best supportive care showed statistically significant improvement in OS compared with placebo plus best supportive care.
- KEYNOTE-394 also met its key secondary endpoints of progression-free survival (PFS) and objective response rate (ORR), with statistically significant improvements for Keytruda compared with placebo.
- No new safety signals were observed. These results will be presented at an upcoming medical meeting.
- Keytruda was granted accelerated approval in November 2018 for patients with HCC who have been previously treated with sorafenib, based on ORR and durability of response data from KEYNOTE-224.
- A subsequent study, KEYNOTE-240, did not meet its dual primary endpoints of OS and PFS.
- The FDA's Oncologic Drugs Advisory Committee (ODAC) meeting in April discussed the accelerated approval that voted 8-0 in favor of maintaining accelerated approval of Keytruda for this indication.
- Price Action: MRK stock is up 0.15% at $73.72 during the market session on the last check Monday.
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Posted-In: Briefs Hepatocellular Carcinoma Liver Cancer Phase 3 TrialBiotech News Health Care General
