Plenary Session: Genitourinary Cancer—Kidney/Bladder[view all in session]
2026-04-03 · 18:15 CT · S100A · Sponsor: Bristol-Myers Squibb
Background: Despite the availability of immune checkpoint inhibitors, optimal first-line therapy for RCC remains an open question. Opdivo (undefined) is a anti-PD-1 mAb.
Methods: III-phase, randomized trial (CheckMate-354, NCT07610527). Patients with RCC were randomized to Opdivo or placebo + chemotherapy. Primary endpoint: overall survival.
Results: OS 35.5 months (HR 0.65, 95% CI 0.55-0.75, p0.03). PFS 21.2 months. ORR 59.2%.
Conclusions: Median OS 35.5 months. HR 0.65 (95% CI 0.55–0.75). Grade ≥3 AEs consistent with prior reports.
Clinical trial information: NCT07610527
▸ Author disclosures
H. Borghaei: Consulting/advisory — Bristol-Myers Squibb; Research funding (institution) — Bristol-Myers Squibb.