Keytruda Meets Endpoints in KEYNOTE Trial, Treatment of Hepatocellular Carcinoma


The medication has met the criteria of overall survival for individuals with this type of liver cancer who were previously treated with sorafenib, Merck says.

The phase 3 KEYNOTE-394 trial of Keytruda (pembrolizumab, Merck), an anti-PD-1 therapy, met its primary endpoint of overall survival for Asian individuals with advanced hepatocellular carcinoma who were previously treated with sorafenib, Merck said in a statement.

“Frequently diagnosed at an advanced stage, hepatocellular carcinoma has 1 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,” Scot Ebbinghaus, MD, vice president of clinical research at Merck Research Laboratories, said in a statement.

“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,” he said.

Investigators found that treatment with pembrolizumab and supportive care significantly improved overall survival compared with the placebo and supportive care.

The phase 3 trial also met secondary endpoints of progression-free survival and objective response rate with significant improvements for pembrolizumab compared with the placebo.

Keytruda was granted accelerated approval in November 2018 for individuals with hepatocellular carcinoma who were previously treated with sorafenib, which was based on the objective response rate and durability from KEYNOTE-224.

In April 2021, the FDA’s Oncologic Drugs Advisory Committee voted to maintain the accelerate approval.

Merck announces KEYTRUDA (pembrolizumab) met primary endpoints of overall survival (OS) for patients with advance hepatocellular carcinoma previously treated with sorafenib. Merck. News release. September 27, 2021. Accessed September 28, 2021.

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