Nivolumab plus ipilimumab combo to treat renal cancer in EU

March 7, 2019 0 By FM

T he European Commission has approved the combination of nivolumab (Opdivo) 3 mg/kg plus low dose ipilimumab (Yervoy) 1 mg/kg 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 EU, Bristol-Myers Squibb Company announced.

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 nivolumab plus low-dose ipilimumab demonstrated a significant increase in overall survival, with a 37% decreased risk of death in intermediate- and poor-risk patients compared to a current standard of care, sunitinib.

Nivolumab plus low-dose ipilimumab also demonstrated a higher objective response rate of 41.6% versus 26.5% for sunitinib and a complete response rate of 9.4% for the nivolumab plus low-dose ipilimumab cohort versus 1.2% for the sunitinib arm.

CheckMate -214 is a Phase 3, randomized, open-label study evaluating the combination of nivolumab 3 mg/kg plus ipilimumab 1 mg/kg versus sunitinib in patients with previously untreated advanced RCC. In the intermediate- and poor-risk study population, 425 patients received nivolumab 3 mg/kg plus ipilimumab 1 mg/kg every three weeks for four doses, followed by nivolumab 3 mg/kg every two weeks, and 422 patients received sunitinib 50 mg once daily for four weeks, followed by two weeks off every cycle.

Patients were included regardless of their PD-L1 status.