Opdivo + Yervoy combination fails to meet primary endpoint in CHECKMATE 451 trial to treat small cell lung cancer.- BMS

Bristol-Myers Squibb Company announced that the Phase III CheckMate -451 study did not meet its primary endpoint of overall survival (OS) with Opdivo (nivolumab) 1 mg/kg in combination with Yervoy (ipilimumab) 3 mg/kg versus placebo as a maintenance therapy for patients with extensive-stage small cell lung cancer (SCLC) without disease progression after completion of first-line platinum-based chemotherapy. No new safety signals were observed with Opdivo 1 mg/kg plus Yervoy 3 mg/kg in this study. The Company will work with study investigators on the future publication of these results.

CheckMate-451 is a global, double-blind, randomized Phase III study evaluating Opdivo in combination with Yervoy and Opdivo monotherapy versus placebo as a maintenance therapy in patients with extensive-stage small cell lung cancer without disease progression after completion of first-line platinum-based chemotherapy. The primary endpoint of the study is overall survival (OS) with Opdivo plus Yervoy versus placebo. The secondary endpoint is OS with Opdivo monotherapy versus placebo.

Comment: Small cell lung cancer (SCLC) is one of two main types of lung cancer and accounts for about 10% to 15% of all lung cancers. SCLC is an aggressive disease and symptoms often are not detected until the cancer is at an advanced stage. Chemotherapy has been the standard of care in the frontline setting, with or without radiation therapy. Despite responding to initial treatment, the majority of patients experience relapse within one year (the return of disease after a period of improvement)..