Bristol-Myers Squibb Company announced that the European Commission has approved the combination of Opdivo (nivolumab) 3 mg/kg plus Yervoy (ipilimumab) 1 mg/kg (low-dose) for the first-line treatment of patients with intermediate- and poor-risk advanced renal cell carcinoma (RCC). This decision represents the first approval of an Immuno-Oncology (I-O) combination therapy for patients with this type of cancer in the European Union. The approval is based on results from the Phase 3 CheckMate -214 clinical trial, which was stopped early following a planned interim analysis that showed that the combination of Opdivo plus low-dose Yervoy demonstrated a significant increase in overall survival (OS), with a 37% decreased risk of death in intermediate- and poor-risk patients compared to a current standard of care, sunitinib (Hazard Ratio [HR] 0.63; 99.8% Confidence Interval [CI]: 0.44 to 0.89; p<0.0001). The OS benefit was observed regardless of PD-L1 expression level. Median OS in patients treated with Opdivo plus low-dose Yervoy was not yet reached (95% CI: 28.2 to not estimable [NE]), compared to 25.9 months for patients treated with sunitinib. Opdivo plus low-dose Yervoy also demonstrated a higher objective response rate of 41.6% (95% CI: 36.9 to 46.5; p<0.0001; n=177/425) versus 26.5% for sunitinib (95% CI: 22.4 to 31.0; n=112/422) and a complete response rate of 9.4% for the Opdivo plus low-dose Yervoy cohort versus 1.2% for the sunitinib arm. Among patients who responded, median duration of response in patients treated with Opdivo plus low-dose Yervoy was not yet reached (95% CI: 21.8 to NE) compared to 18.2 months for sunitinib (95% CI: 14.8 to NE). The combination of Opdivo plus low-dose Yervoy was also associated with fewer overall Grade 3 or 4 adverse events compared to sunitinib (65% versus 76%).