FDA backs Opdivo combo with Yervoy as first-line RCC therapy

The combination of Opdivo (nivolumab) 3mg/kg plus Yervoy (ipilimumab) 1mg/kg (injections for intravenous use) has received priority approval from the US 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), according the Bristol-Myers Squibb (NYSE: BMY), the developer of both compounds.

In the Phase III CheckMate -214 clinical trial, the Opdivo + Yervoy combination demonstrated a significant and unprecedented increase in overall survival (OS) in this patient population compared to a current standard of care, sunitinib. An OS benefit was observed regardless of PD-L1 expression level. Opdivo + Yervoy also delivered durable responses, with a higher objective response rate (ORR) compared to sunitinib. Patients in the CheckMate -214 trial received four cycles of the Opdivo + low-dose Yervoy combination, followed by Opdivo maintenance therapy. In the combination arm of the trial, 79% of patients received all four doses of Opdivo + Yervoy and went on to the Opdivo monotherapy phase. Flexible dosing options are available during the Opdivo maintenance phase (480mg infused every four weeks or 240mg infused every two weeks).

Bristol-Myers has already gained approval for the Opdivo and Yervoy combination in melanoma, which is also being tested in several other tumor types including non-small cell lung cancer.