Merck's Keytruda Tops Placebo On Overall Survival Endpoint In Liver Cancer Patients

Merck & Co Inc 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.