US regulators have expanded the use of MSD’s anti-PD-1 therapy Keytruda to include treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
The indication was approved under the accelerated approval process based on tumor response rate and durability of response, and so continued clearance may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Approval was issued on the back of data from the KEYNOTE-224 study, a single-arm, open-label, multicenter trial evaluating Keytruda (pembrolizumab) in 104 patients with HCC who had disease progression on or after sorafenib or were intolerant to sorafenib.
Results showed an objective response rate of 17%, with a complete response rate of 1% and a partial response rate of 16%. Among the responding patients (n=18), 89% experienced a duration of response (DOR) for six months or longer and 56% experienced a DOR for 12 months or longer.
“Hepatocellular carcinoma is the most common type of liver cancer in adults, and while we have seen recent therapeutic advancements, there are still limited treatment options for advanced recurrent disease,” said Dr Andrew X. Zhu, lead investigator and director of liver cancer research at Massachusetts General Hospital and professor of medicine at Harvard Medical School.
The approval of Keytruda “is important, as it provides a new treatment option for patients with hepatocellular carcinoma who have been previously treated with sorafenib.”