European Commission approves Bavencio + axitinib combination for first line treatment of patients with advanced renal cell carcinoma.- Merck KGaA + Pfizer.

Merck KGaA and Pfizer Inc announced that the European Commission (EC) has approved Bavencio (avelumab) in combination with axitinib for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

The approval was based on positive interim results from the Phase III JAVELIN Renal 101 study, which demonstrated that Bavencio in combination with axitinib significantly lowered risk of disease progression or death by 31% (HR: 0.69 [95% CI: 0.574�0.825; p<0.0001]) and nearly doubled objective response rate orr 52.5 95 ci: 47.7-57.2 vs. 27.3 95 ci: 23.2-31.6 compared with sunitinib in patients with advanced rcc regardless of pd-l1 status. the study included patients across international metastatic renal cell carcinoma database consortium imdc prognostic risk groups.>

Improvement in progression-free survival (PFS) was observed across pre-specified subgroups in patients receiving the treatment combination. Merck and Pfizer have a global strategic alliance to jointly develop and commercialize Bavencio.