Phase III JAVELIN Bladder 100 study met its primary endpoint to treat urothelial carcinoma .- Merck KGaA + Pfizer

Merck and Pfizer Inc. announced the Phase III JAVELIN Bladder 100 study met its primary endpoint of overall survival (OS) at the planned interim analysis. In this study, patients with previously untreated locally advanced or metastatic urothelial carcinoma (UC) whose disease did not progress on induction chemotherapy and who were randomized to receive first-line maintenance therapy with Bavencio (avelumab) and best supportive care (BSC) lived significantly longer than those who received BSC only. A statistically significant improvement in OS was demonstrated in the Bavencio arm in each of the co-primary populations: all randomized patients and patients with PD-L1–positive tumors. The safety profile for Bavencio in the trial was consistent with that in the JAVELIN monotherapy clinical development program. The results of the study will be submitted for presentation at an upcoming medical congress and shared with the FDA and other health authorities. Comment:In 2017, the FDA approved Bavencio for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response and duration of response. JAVELIN Bladder 100 is the confirmatory study for the conversion to full approval.