The EMA accepted BMS’ type II variation application for Opdivo + cisplatin-based CT as 1L treatment of adult patients with unresectable/metastatic urothelial carcinoma based on the results from the P-III (CheckMate-901) study
The P-III (CheckMate-901) clinical trial evaluates the safety & efficacy of Opdivo (360mg, Q3W) + cisplatin-based CT followed by Opdivo monotx. (480mg, Q4W) vs SoC CT in patients (n=608) with urothelial carcinoma. The company is currently evaluating Opdivo + Yervoy vs SoC CT for the same indication
The P-III efficacy results, presented at ESMO’23, showed improved OS and PFS as evaluated by BICR. Safety profiles were tolerable and consistent
Ref: BMS | Image: BMS
Related News:- BMS Reports Three-Year Follow-Up Results from Exploratory Analyses of P-III Trial (CheckMate -816) for Opdivo to Treat Resectable Non-Small Cell Lung Cancer
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