CheckMate-057 trial of Opdivo (nivolumab) for NSCLC meets endpoint and is stopped early- BMS
BMS announced that an open-label, randomized Phase III study (CheckMate -057) evaluating Opdivo (nivolumab) versus docetaxel in previously treated patients with advanced non-squamous non-small cell lung cancer (NSCLC) was stopped early because an assessment conducted by the independent Data Monitoring Committee (DMC) concluded that the study met its endpoint, demonstrating superior overall survival in patients receiving Opdivo compared to the control arm. The company looks forward to sharing these data with health authorities soon.
CheckMate -057 is a Phase III, open-label, randomized study of Opdivo versus docetaxel in previously treated patients with advanced or metastatic non-squamous NSCLC. The trial randomized 582 patients to receive either nivolumab 3 mg/kg intravenously every two weeks or docetaxel 75 mg/m2 intravenously every three weeks. The primary endpoint is overall survival. Secondary endpoints include objective response rate and progression free survival.
Comment:The results of CheckMate -057 mark the second time Opdivo has demonstrated a survival advantage in lung cancer.
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