Early FDA nod for Bavencio combo as RCC treatment

The US Food and Drug Administration has approved Bavencio(avelumab) in combination with axitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC; kidney cancer), said Germany’s Merck KGaA (MRK: DE) and its partner US pharma giant Pfizer (NYSE: PFE).

Coming earlier than the agency’s expected action date in June, this is the first FDA approval for an anti-PD-L1 therapy as part of a combination regimen for patients with advanced RCC, the companies noted.

The approval of Bavencio in combination with axitinib (marketed by Pfizer as Inlyta) 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%).1