By Michael Dabaie


Merck & Co. Inc. said the Phase 3 Keynote-394 trial investigating Keytruda in Asian patients with advanced hepatocellular carcinoma, a form of liver cancer, met its primary objective of overall survival.

Hepatocellular carcinoma is the most common form of primary liver cancer, which is the sixth most frequently diagnosed cancer worldwide. Keynote-394 looked at patients previously treated with sorafenib.

The study found that treatment with Keytruda plus best supportive care resulted in a statistically significant improvement in overall survival compared with placebo plus best supportive care. The study also met its key secondary endpoints of progression-free survival and objective response rate, with statistically significant improvements for Keytruda compared with placebo.

"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 of clinical research for Merck Research Laboratories.

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 the Keynote-224 study. A subsequent study, Keynote-240, didn't meet its dual primary endpoints of OS and PFS.


Write to Michael Dabaie at


(END) Dow Jones Newswires

September 27, 2021 07:56 ET (11:56 GMT)

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