EU approves Bavencio for locally advanced or metastatic urothelial carcinoma.- Merck KGaA + Pfizer

Merck KGaA and Pfizer Inc. announced that the European Commission has approved Bavencio (avelumab) as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum-based chemotherapy.In the pivotal JAVELIN Bladder 100 trial, Bavencio plus best supportive care (BSC) as first-line maintenance demonstrated a significant improvement in median overall survival (OS) vs BSC alone at the prespecified interim analysis (data cut-off date Oct. 21, 2019): 21.4 months (95% CI: 18.9 to 26.1) vs 14.3 months (95% CI: 12.9 to 17.8) in the coprimary population of all randomized patients (HR 0.69; 95% CI: 0.56 to 0.86). In the coprimary population of patients with PD-L1+ tumors (n=358), OS was also significantly longer with Bavencio plus BSC (median not reached; 95% CI: 20.3, not reached) vs BSC alone (17.1 months; 95% CI: 13.5, 23.7; HR 0.56; 95% CI, 0.40 to 0.79). Based on these data, the Bavencio first-line maintenance regimen was added to the recently updated ESMO Clinical Practice Guidelines for bladder cancer.Updated OS results with a data cut-off of Jan. 19, 2020 also showed Bavencio significantly extended OS among all randomized patients vs BSC alone (HR 0.70; 95% CI, 0.56 to 0.86; two-sided P=0.0008), with median OS of 22.1 months (95% CI, 19.0 to 26.1) vs 14.6 months (95% CI, 12.8 to 17.8), respectively.