Keytruda significantly improved PFS compared with brentuximab vedotin in relapsed or refractory classical Hodgkin lymphoma. - Merck Inc.

Merck Inc., announced that the Phase III KEYNOTE-204 trial evaluating Keytruda, Merck’s anti-PD-1 therapy, for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) met one of its dual primary endpoints of progression-free survival (PFS) . Based on an interim analysis conducted by an independent Data Monitoring Committee (DMC), Keytruda demonstrated a statistically significant and clinically meaningful improvement in PFS compared with brentuximab vedotin (BV) in this patient population. Per the pre-specified analysis plan, the other dual primary endpoint of overall survival (OS) was not formally tested at this interim analysis. The study will continue to evaluate OS. The safety profile of Keytruda in this trial was consistent with previously reported studies, and no new safety signals were identified. Results will be presented at an upcoming medical meeting and submitted to regulatory authorities. In March 2017, Keytruda was approved by the FDA for the treatment of adult and pediatric patients with refractory cHL, or who have relapsed after three or more prior lines of therapy. This accelerated approval was based on results of the Phase II KEYNOTE-087 trial; the Phase III KEYNOTE-204 trial is a confirmatory trial for Keytruda’s current indication in cHL..