Bristol-Myers Squibb's Opdivo (nivolumab) plus Yervoy (ipilimumab) combo was approved by the U.S. Food and Drug Administration as the first Immuno-Oncology combination therapy for previously untreated patients with intermediate- and poor-risk advanced renal cell carcinoma (RCC).
In the Phase 3 CheckMate -214 clinical trial, the combination demonstrated a significant increase in overall survival in the patient population compared to a current standard of care, sunitinib. An OS benefit was observed regardless of PD-L1 expression level. In the CheckMate -214 trial, which used dosing optimized for advanced renal cell carcinoma, Opdivo + Yervoy was associated with fewer overall Grade 3 or 4 adverse reactions than sunitinib.
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