CheckMate -057 is an open-label study that randomized 582 patients to receive either nivolumab or docetaxel. The primary endpoint is overall survival. Patients who were receiving Opdivo demonstrated superior overall survival compared to the control arm. Based on these results, an independent Data Monitoring Committee determined that the CheckMate-057 trial should be stopped early because the primary endpoint was met.
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is already approved as monotherapy for the treatment of patients with metastatic squamous NSCLC with progression on or after platinum-based chemotherapy and for the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor.
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