Merck announced that the Phase 3 KEYNOTE-394 trial investigating KEYTRUDA 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.
“Frequently diagnosed at an advanced stage, hepatocellular carcinoma has one of the highest mortality rates of solid cancers. Despite recent progress, there remains an unmet need for anti-PD-1 monotherapy after sorafenib, where KEYTRUDA is an established treatment option for patients,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “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.”
KEYTRUDA was granted accelerated approval in November 2018 for the treatment of 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. This accelerated approval for KEYTRUDA was discussed during the FDA’s Oncologic Drugs Advisory Committee (ODAC) meeting on April 29, 2021 that voted 8-0 in favor of maintaining accelerated approval of KEYTRUDA for this indication.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox! Sign up now!