Dr. Galsky on Updated CheckMate 274 Data With Adjuvant Nivolumab in Urothelial Carcinoma

Matthew Galsky, MD, professor of medicine (Hematology and Medical Oncology), director of genitourinary medical oncology, Icahn School of Medicine at Mount Sinai; codirector of the Center of Excellence for Bladder Cancer, and associate director for Translational Research at The Tisch Cancer Institute, discusses long-term data from the phase 3 CheckMate 274 trial (NCT02632409) evaluating adjuvant nivolumab (Opdivo) vs placebo in patients with high-risk, muscle-invasive urothelial cancer.

Prior data from the trial showed that at a minimum follow-up of 5.9 months, adjuvant nivolumab improved disease-free survival (DFS) vs placebo in the intent-to-treat population (HR 0.70; 98.22% CI, 0.55-0.90; P < .001), and in the subset of patients with a PD-L1 expression of at least 1% (HR 0.55; 98.72% CI, 0.35-0.85; P < .001), according to Galsky.

The long-term follow-up data presented during the 2022 American Urological Association Annual Meeting showed that at a minimum follow-up of 11 months, nivolumab maintained its DFS benefit over placebo, Galsky says. In the ITT population, treatment with nivolumab resulted in a median DFS of 22.0 months (95% CI, 17.7-36.9) compared with 10.9 months (95% CI, 8.3-14.0) with placebo; the HR was 0.70 (95% CI, 0.57-0.85), Galsky adds.

Adjuvant nivolumab also continued to improve DFS over placebo in patients with a PD-L1 expression of at least 1%, with a median DFS that had not yet been reached (95% CI, 22.1–not estimable) compared with 8.4 months (95% CI, 5.6-20.0) with placebo; in this subset, the HR was 0.53 (95% CI, 0.38-0.75), Galsky concludes.