Bristol-Myers Squibb Release: Two Pivotal Opdivo (Nivolumab) Trials Show Three-Year Survival Benefit In Patients With Previously Treated Advanced Non-Small Cell Lung Cancer

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced three-year overall survival (OS) data from CheckMate -017 and CheckMate -057, two pivotal Phase 3 randomized studies evaluating Opdivo versus docetaxel in patients with previously treated metastatic non-small cell lung cancer (NSCLC). In CheckMate -017, a trial in previously treated squamous NSCLC, 16% of patients treated with Opdivo were alive at three years (21/135) versus 6% of those treated with docetaxel (8/137) (HR 0.62; 95% CI: 0.48 to 0.80). In CheckMate -057, a trial in previously treated non-squamous NSCLC, 18% of patients treated with Opdivo were alive at three years (49/292) versus 9% of those treated with docetaxel (26/290) (HR 0.73; 95% CI: 0.62 to 0.88). Similar to prior reports, an OS benefit was observed across histologies, and three-year survivors included patients whose tumors expressed PD-L1 and those that did not. With three years’ minimum follow-up, no new safety signals were identified for Opdivo, and the safety profile across both trials was consistent with prior reports.

Enriqueta Felip, M.D., head of the Thoracic Tumors Group, Vall d’Hebron Institute of Oncology, Barcelona, Spain, commented, “Opdivo is already a standard of care in previously treated non-small cell lung cancer across histologies, demonstrating durable, long-term survival in two pivotal Phase 3 studies. Data from CheckMate -017 and CheckMate -057 continue to reinforce the compelling and sustained survival benefit demonstrated with Opdivo for these patients even after three years. These results are important for the clinical community and represent the longest follow-up data reported for a PD-1 inhibitor versus chemotherapy in second-line NSCLC.”