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Adjuvant Treatment with Opdivo (nivolumab) Demonstrates Statistically Significant and Clinically Meaningful Improvement in Disease-Free Survival in Patients with Muscle-Invasive Urothelial Carcinoma in Phase 3 CheckMate -274 Trial

Published: 2021-02-08 22:00:00 ET
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Patients who received Opdivo after surgery lived nearly twice as long without disease recurrence compared to those who received placebo

With the positive results from CheckMate -274, Opdivo has shown benefit in Phase 3 trials across four different types of early resectable cancer

Data from CheckMate -274 to be presented for the first time at the 2021 Genitourinary Cancer Symposium

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced results from the Phase 3 CheckMate -274 trial, which showed that Opdivo (nivolumab) significantly improved disease-free survival (DFS) as an adjuvant treatment across all randomized patients with surgically resected, high-risk muscle-invasive urothelial carcinoma and in the subgroup of patients whose tumors express PD-L1 ≥1%, meeting both of the study’s primary endpoints. CheckMate -274 is the first positive Phase 3 trial evaluating an immunotherapy in the adjuvant setting of muscle-invasive urothelial carcinoma.

Across all randomized patients, Opdivo nearly doubled the average length of time patients lived without disease recurrence, demonstrating a median disease-free survival of 21.0 months compared to 10.9 months with placebo, a risk reduction of 30% (Hazard Ratio [HR] 0.70, 98.31% Confidence Interval [CI]: 0.54 – 0.89, p