Adjuvant nivolumab (NIVO) vs placebo (PBO) for high-risk muscle-invasive urothelial carcinoma (MIUC): Additional efficacy outcomes including overall survival (OS) in patients (pts) with muscle-invasive bladder cancer (MIBC) from CheckMate 274.

• DOI: 10.1200/jco.2025.43.5_suppl.658
• Publication Date: 2025-02-18T14:32:12Z
• Authors: Matthew I. Milowsky; Matthew D. Galsky; Johannes Alfred W...; Jürgen E. Gschwend; Michael Schenker; Begona Perez Vald...; Yoshihiko Tomita; Aristotelis Bamias; Thierry Lebret; Shahrokh F. Shariat; Se Hoon Park; Mads Agerbaek; Gautam Gopalji Jha; Frank Stenner; Dingwei Ye; Fabio Giudici; Jessica Connors; Joshua Zhang; Dean F. Bajorin
• Keywords: Urothelial cancer

658 Background: In the phase 3, randomized, double-blind CheckMate 274 trial, adjuvant NIVO demonstrated statistically significant and clinically meaningful disease-free survival (DFS) benefit vs PBO in pts with high-risk MIUC after radical surgery (RS) ± prior neoadjuvant cisplatin-based chemotherapy (NAC). With extended 3-y median follow-up, continued improvements DFS were seen primary efficacy populations (intent-to-treat [ITT], tumor programmed death ligand 1 [PD-L1] expression ≥ 1%) MIBC. Early trends interim OS favored ITT PD-L1 1% pts. Here we report additional outcomes for Methods: Pts randomized 1:1 to 240 mg every 2 wk or ≤ y of treatment, stratified by expression, nodal status, NAC. Primary endpoints was a secondary endpoint. Analysis MIBC exploratory. data are from preplanned analyses follow-up is ongoing as prespecified statistical boundaries significance not crossed at time these analyses. Results: Of 709 (ITT), 560 (79%) had (NIVO, n = 279; PBO, 281); 284 (51%) 36.1 mo improvement consistent between all (hazard ratio [HR] 0.63) those (HR 0.58) without NAC 0.69; Table). For OS, HRs 0.70) subgroup 0.48), well 0.74) 0.67). Safety previous pts; no new safety signals identified. Conclusions: benefit observed across subgroups. The HR pts, 1%, regardless status. These results continue support standard care MIBC, potentially providing an opportunity curative outcome. Clinical trial information: NCT02632409 . NIVOn NIVOMedian(95% CI), PBOn PBOMedian(95% (95% CI) All 279 25.6 (19.2–41.8) 281 8.5 (7.3–13.7) 0.63 (0.51–0.78) 142 19.6 (15.6–48.2) 8.3 (5.6–11.2) 0.58 (0.43–0.79) No 137 25.9 (19.2–51.5) 139 13.7 (7.8–22.1) 0.69 (0.50–0.94) NR (45.0–NE) 39.9 (29.8–52.1) 0.70 (0.55–0.90) 113 (NE–NE) 117 37.6 (26.9–NE) 0.48 (0.29–0.77) 55.2 (41.8–NE) 40.2 (28.8–53.7) 0.74 (0.53–1.03) (40.7–NE) 37.7 (28.7–65.2) 0.67 (0.47–0.95) NE, estimable; NR, reached.