Phase III trial of Opdivo (nivolumab) in squamous cell carcinoma of the head and neck stopped early- BMS

Bristol-Myers Squibb announced that a randomized Phase III study evaluating Opdivo (nivolumab) versus investigator’s choice in patients with recurrent or metastatic platinum-refractory squamous cell carcinoma of the head and neck (SCCHN) was stopped early because an assessment conducted by the independent Data Monitoring Committee (DMC) concluded that the study met its primary endpoint, demonstrating superior overall survival (OS) in patients receiving Opdivo compared to the control arm. The company looks forward to sharing these data with health authorities soon.

CheckMate -141 is a Phase III, open-label, randomized study of Opdivo versus investigator’s choice of therapy in previously treated patients with SCCHN who have tumor progression on or within 6 months of platinum therapy in the primary, recurrent, or metastatic setting. The trial randomized 361 patients 2:1 to receive either Opdivo 3 mg/kg intravenously every two weeks or investigator’s choice (cetuximab/methotrexate/docetaxel) until documented disease progression or unacceptable toxicity. The primary endpoint is OS. Secondary endpoints include objective response rate and progression free survival.