FDA has approved an EMD Serono and Pfizer NDA for Bavencio (avelumab) in combination with Pfizer’s Inlyta (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 companies say. Approval was based on data from the Phase 3 JAVELIN Renal 101 study (NCT02684006), in which the combination significantly improved median progression-free survival compared with sunitinib by more than five months in the intent-to-treat patient population.
RCC is a type of cancer where PD-L1 expression may contribute to inhibition of the immune response against the tumor, the companies say. It is also a highly vascular tumor, in which vascular endothelial growth factor plays a key role.