FDA approves Bavencio + Inlyta to treat renal cell carcinoma

Merck and Pfizer Inc. announced that the FDA has approved Bavencio (avelumab) in combination with axitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC). This is the first FDA approval for an anti-PD-L1 therapy as part of a combination regimen for patients with advanced RCC.

The approval of Bavencio in combination with axitinib was based on positive results from the Phase III JAVELIN Renal 101 study (NCT02684006 ), in which the combination significantly improved median progression-free survival (PFS) compared with sunitinib by more than five months in the intent-to-treat (ITT) patient population (HR: 0.69 [95% CI: 0.56–0.84]; 2-sided p-value=0.0002; median PFS for Bavencio in combination with axitinib: 13.8 months [95% CI: 11.1-NE]; sunitinib: 8.4 months [95% CI: 6.9-11.1]). The ITT population included patients regardless of PD-L1 expression and across IMDC (International Metastatic Renal Cell Carcinoma Database) prognostic risk groups (favorable 21%, intermediate 62% and poor 16%).

There is a significant unmet need for first-line treatments that delay progression and have an acceptable safety profile. Approximately 20% to 30% of patients are first diagnosed with RCC at the advanced stage, and 30% of patients treated for an earlier stage go on to develop metastases. About half of patients living with advanced RCC do not go on to receive additional treatment after first-line therapy, for reasons that may include poor performance status or adverse events from their initial treatment.

The European Medicines Agency (EMA) validated the Type II variation application for Bavencio in combination with axitinib in advanced RCC in March 2019, and a supplemental application for Bavencio in combination with axitinib in unresectable or metastatic RCC was submitted in Japan in January 2019. The combination of Bavencio and axitinib is only approved for the first-line treatment of advanced RCC in the United States.