The Phase III KEYNOTE-240 trial evaluating Keytruda for advanced hepatocellular carcinoma (liver cancer)did not meet its co-primary endpoints.Merck Inc,.

Merck Inc., announced that the pivotal Phase III KEYNOTE-240 trial evaluating Keytruda, Merck�s anti-PD-1 therapy, plus best supportive care, for the treatment of patients with advanced hepatocellular carcinoma (HCC) who were previously treated with systemic therapy, did not meet its co-primary endpoints of overall survival (OS) and progression-free survival (PFS) compared with placebo plus best supportive care.

In the final analysis of the study, there was an improvement in OS for patients treated with Keytruda compared to placebo, however these OS results did not meet statistical significance per the pre-specified statistical plan (HR=0.78 [95% CI, 0.611-0.998]; p=0.0238). Results for PFS were also directionally favorable in the Keytruda arm compared with placebo but did not reach statistical significance (HR=0.78 [95% CI, 0.61-0.99]; p=0.0209). The key secondary endpoint of objective response rate (ORR) was not formally tested, since superiority was not reached for OS or PFS. The safety profile of Keytruda in this trial was consistent with that observed in previously reported studies. Results will be presented at an upcoming medical meeting and have been shared with the FDA for discussion.

Keytruda is being studied across multiple settings and lines of therapy for HCC through a broad clinical program that includes 10 clinical trials sponsored by Merck or in collaborations. As monotherapy in second-line HCC, in addition to KEYNOTE-240 and KEYNOTE-224, Keytruda is being investigated in the ongoing Phase III, KEYNOTE-394 trial, a randomized, double-blind trial evaluating Keytruda in combination with best supportive care, compared to placebo in combination with best supportive care, in Asian patients with advanced HCC who were previously treated with systemic therapy. In addition, there are several ongoing trials investigating Keytruda in combination with other treatments, including therapies through our collaborations..