CHECKMATE 238 trial shows Opdivo superior to Yervoy for stage IIIB/C or stage IV high risk of recurrence melanoma.- BMS.

Bristol-Myers Squibb Company announced updated results from the Phase III CheckMate -238 trial evaluating Opdivo (nivolumab) versus Yervoy (ipilimumab) in patients with stage IIIB/C or stage IV melanoma who are at high risk of recurrence following complete surgical resection.

In updated results from the study, Opdivo continued to demonstrate statistically longer recurrence-free survival (RFS) of 62.6%, the primary endpoint of the study, versus 50.2% for Yervoy (HR: 0.66, P<0.0001) at a minimum follow-up of 24 months across key subgroups, including disease stages and BRAF mutation status. No new safety data were generated as part of the 24-month analysis.

As previously reported from the 18-month analysis, Opdivo demonstrated a significantly lower rate of adverse events (AEs) leading to discontinuation (9.7% of patients in the Opdivo arm compared to 42.6% of patients in the Yervoy arm) and treatment-related grade 3/4 AEs (14.4% of patients in the Opdivo arm compared to 45.9% in the Yervoy arm). Findings were presented on Monday, June 4 from 8:24-8:36 AM CDT during the Melanoma/Skin Cancers session at the American Society of Clinical Oncology (ASCO) Annual Meeting 2018 in Chicago (Abstract #9502).

Additional Data from CheckMate -238 at ASCO 2018: In the study, Opdivo demonstrated superior RFS versus Yervoy, regardless of disease stage, PD-L1 expression or BRAF mutation status, with RFS rates of 62.6% with Opdivo compared to 50.2% with Yervoy in the intent-to-treat patient population. In patients with stage IIIB melanoma, RFS rates at 24 months for Opdivo were 70.8% versus 60.7% with Yervoy; for patients with stage IIIC melanoma, RFS rates were 58.0% with Opdivo versus 45.4% with Yervoy; and for patients with stage IV melanoma, RFS rates for Opdivo were 58.0% versus 44.3% with Yervoy. In patients with BRAF mutant melanoma, RFS rates for Opdivo were 61.9% versus 51.7% with Yervoy; in patients with BRAF wild-type melanoma, Opdivo demonstrated a RFS of 63.5% versus 46.2% with Yervoy.