Merck and Pfizer’s Bavencio approved for renal cell carcinoma

Merck KGaA and Pfizer’s immunotherapy Bavencio (avelumab) has been approved by the FDA in combination with Pfizer’s Inlyta (axitinib) for the first-line treatment of patients with advanced renal cell carcinoma (RCC). The accelerated approval was based on positive results from the Phase III JAVELIN Renal 101 study, which showed the combination significantly lowered risk of disease progression or death by 31% and extended progression-free survival by 5.4 months for patients with advanced RCC compared with sunitinib. This is good news for a drug that has faced some challenges recently. In March, Merck and Pfizer discontinued an ovarian cancer trial for Bavencio. The decision was based on several emerging factors since the trial’s initiation, including interim results from the separate JAVELIN Ovarian 100 trial announced in December showing that Bavencio was unable to improve progression-free survival when used as a maintenance therapy. That failure came just a few weeks after Merck and Pfizer conceded defeat in another phase III study of Bavencio, the JAVELIN Ovarian 200 trial in platinum-resistant or platinum-refractory ovarian cancer.