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Matthew Galsky, MD, discusses long-term data from the phase 3 CheckMate 274 trial evaluating adjuvant nivolumab vs placebo in patients with high-risk, muscle-invasive urothelial cancer.
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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.
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