Phase III KEYNOTE-394 trial of Keytruda meets primary endpoint in hepatocellular carcinoma – Merck Inc

Merck Inc announced that the Phase III KEYNOTE-394 trial investigating Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in Asian patients with advanced hepatocellular carcinoma (HCC) previously treated with sorafenib met its primary endpoint of overall survival (OS).

The study found that treatment with Keytruda plus best supportive care resulted in a 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.

KEYNOTE-394 is a randomized, double-blind, Phase III trial (ClinicalTrials.gov, NCT03062358) evaluating Keytruda plus best supportive care versus placebo plus best supportive care in Asian patients with advanced HCC previously treated with sorafenib or oxaliplatin chemotherapy. The primary endpoint is OS and secondary endpoints include PFS, ORR, duration of response and disease control rate. The study enrolled 453 patients who were randomized to receive either Keytruda (intravenously every three weeks for up to 35 cycles of treatment [up to approximately two years]) plus best supportive care (including pain management and management of other potential complications including ascites per local standards of care) or placebo plus best supportive care.