Bristol-Myers Squibb Release: Opdivo (Nivolumab) Demonstrates Superior Recurrence-Free Survival Versus Yervoy (Ipilimumab) For Patients With Resected High-Risk Melanoma In Phase III Checkmate -238 Study
Published: Sep 11, 2017
Opdivo decreased the risk of disease recurrence by 35% compared to Yervoy
Opdivo is the first anti-PD-1 to improve RFS and only I-O therapy to demonstrate superiority versus an active control in this patient population
Adjuvant treatment with Opdivo was well tolerated, with 14% of patients experiencing grade 3/4 adverse events and 10% discontinuing due to toxicity
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) announced today that treatment with Opdivo (nivolumab) 3 mg/kg resulted in a significant improvement in recurrence-free survival (RFS) compared to Yervoy (ipilimumab) 10 mg/kg in patients with stage IIIb/c or stage IV melanoma following complete surgical resection. Following the July 5 announcement of topline results, detailed findings from the phase 3 CheckMate -238 study will be highlighted on September 11 during the European Society for Medical Oncology (ESMO) 2017 Congress in Madrid, Spain as part of the press program at 8:15 a.m. CEST and in Presidential Symposium 3 (LBA8) at 4:30 p.m. CEST. The results are also being published simultaneously in the New England Journal of Medicine.
At this planned interim analysis, Opdivo met its primary endpoint, showing a statistically significant improvement of 35% in RFS (HR 0.65; 97.56% CI: 0.51 to 0.83; p <0.0001) compared to Yervoy. The 18-month RFS rates for the Opdivo and Yervoy groups, respectively, were 66.4% (95% CI: 61.8 to 70.6) and 52.7% (95% CI: 47.8 to 57.4). Median RFS had not yet been reached for either group at the time of this analysis. This benefit was consistent across key subgroups, including BRAF mutated and BRAF wildtype patients, and no new safety signals were identified in this trial.