Phase III CheckMate -214 trial of Yervoy + Opdivo shows sustained benefits and four year survival rate in advanced renal cell carcinoma.- BMS

BMS announced that more than half of advanced renal cell carcinoma (RCC) patients treated with the Opdivo(nivolumab)plus Yervoy(ipilimumab)combination were alive after four years across the entire study population of the Phase III CheckMate -214 clinical trial. With the longest follow-up for an immunotherapy-based combination in previously untreated advanced RCC, Opdivo plus Yervoy continued to show superior, long-term overall survival (OS) and durable responses compared to sunitinib. These sustained benefits were observed across both the primary patient population, those with intermediate- and poor-risk prognostic factors, and in the intention-to-treat (ITT, i.e. all randomized) patient population. In intermediate- and poor-risk patients (n=847), Opdivo plus Yervoy maintained improvements in OS and overall response rate (ORR), two of the trial’s co-primary endpoints, as well as in exploratory endpoints such as complete response (CR) and median duration of response (mDOR): OS: The median OS was 48.1 months for intermediate- and poor-risk patients treated with Opdivo plus Yervoy versus 26.6 months for sunitinib (Hazard Ratio [HR] 0.65; 95% Confidence Interval [CI]: 0.54 to 0.78). The dual immunotherapy combination demonstrated a four-year OS rate of 50.0%, compared to 35.8% with sunitinib. ORR: Opdivo plus Yervoy continued to show a numerically higher ORR, with more ongoing responses compared to sunitinib (65% vs. 50%). CR: Consistent with the 42-month analysis, 10% of patients treated with Opdivo plus Yervoy achieved a CR, compared to 1% of patients treated with sunitinib. mDOR: With Opdivo plus Yervoy, mDOR was not reached, while it was 19.7 months with sunitinib. An analysis of the ITT patient population (n=1,096) with 48 months of follow-up showed: OS: Median OS was not reached for all randomized patients in the Opdivo plus Yervoy arm, compared to 38.4 months in the sunitinib arm (HR 0.69; [95% CI: 0.59 to 0.81]). Four-year OS rates were 53.4% and 43.3%, respectively. ORR: Opdivo plus Yervoy continued to show a numerically higher ORR, with more ongoing responses compared to sunitinib (65% vs. 52%). CR: As previously reported, 11% of patients who received Opdivo plus Yervoy achieved a CR, compared to 3% with sunitinib. mDOR: For patients treated with Opdivo plus Yervoy