Data from Pharmawand - Curated by EPG Health - Date added 29 October 2019

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.

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