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# BMS Reports Opdivo Positive Data in Urothelial Carcinoma
- URL: https://www.fdaweb.com/bms-reports-opdivo-positive-data-in-urothelial-carcinoma/
- Published: 2020-09-25T12:00:00.000Z
- Updated: 2026-09-14T16:30:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147735

Bristol Myers Squibb (BMS) says CheckMate-274, a pivotal Phase 3 trial evaluating Opdivo (nivolumab) after surgery in patients with high-risk, muscle-invasive urothelial carcinoma, met its primary endpoints of improving disease-free survival versus placebo in both all randomized patients and in patients whose tumor cells express PD-L1 (programmed death-ligand 1) greater than or equal to 1%. CheckMate-274 is the only Phase 3 trial in which immunotherapy has reduced the risk of relapse in the adjuvant setting for these patients, the [company says](https://www.businesswire.com/news/home/20200924005649/en/Opdivo-nivolumab-Significantly-Improves-Disease-Free-Survival-vs.-Placebo-as-Adjuvant-Therapy-for-Patients-with-High-Risk-Muscle-Invasive-Urothelial-Carcinoma-in-Phase-3-CheckMate--274-Trial?ref=fdaweb.com). Opdivo’s safety profile was consistent with previously reported studies in solid tumors, it adds.

BMS says it plans to complete a full evaluation of the data to present the results at an upcoming medical conference, and submit data to health authorities. “The CheckMate-274 trial will continue as planned to allow for future analyses of secondary endpoints, including overall survival and disease-specific survival,” it says