Matthew Galsky, MD, shares 5-year data from CheckMate 274 in MIUC

Five-year follow-up data from the phase 3 CheckMate 274 study (NCT02632409) continue to support adjuvant nivolumab (Opdivo) as a standard of care for patients with high-risk muscle-invasive urothelial carcinoma (MIUC).

The data were presented at the 2025 European Society for Medical Oncology Congress in Berlin, Germany.¹ During the meeting, presenting author Matthew D. Galsky, MD, joined Urology Times^® to outline the background and key findings from the study.

“With extended follow-up, 5 years of follow-up, there is a sustained benefit of adjuvant nivolumab vs placebo for disease-free survival in both the all randomized patient population and in patients with tumors with high levels of PD-L1 expression,” Galsky explained.

Specifically, 5-year data from the study showed a median disease-free survival of 21.9 months (95% CI, 18.8 to 36.9) in the nivolumab arm vs 11.0 months (95% CI, 8.3 to 16.6) in the placebo arm (HR, 0.74; 95% CI, 0.61 to 0.90). In patients with a PD-L1 expression of 1% or higher, the median disease-free survival was 55.5 months (95% CI, 25.8 to 66.5) in the nivolumab arm vs 8.4 months (95% CI, 5.6 to 20.0) in the placebo arm (HR, 0.58; 95% CI, 0.42 to 0.79).

In an exploratory analysis, the investigators also found that the benefit of adjuvant nivolumab may be more pronounced in patients with detectable ctDNA after surgery.

Galsky noted, “Even though now we know that adjuvant therapy benefit is enriched in patients with detectable ctDNA, and at ESMO this year, we'll see prospective validation of that concept in the IMvigor011 study, what we don't know yet is if we shouldn't treat patients in the adjuvant setting who have undetectable ctDNA. That's a separate question that has not been answered prospectively yet.”

DISCLOSURES: Galsky noted consulting/advisory associations with AbbVie, Alligator Bioscience, Analog Devices, ARS Pharmaceuticals, Asieris Pharmaceuticals, AstraZeneca, Basilea Pharmaceuticals, Bicycle Therapeutics, Bristol Myers Squibb, Curis, Daiichi Sankyo, Dragonfly Therapeutics, EMD Serono, Fujifilm, Genentech, Gilead Sciences, GlaxoSmithKline, Janssen, Merck, Numab Therapeutics, Pfizer, Rappta Therapeutics, Seagen, UroGen Pharma, and Veracyte.

REFERENCE

1. Galsky MD, Gschwend J, Milowsky M, et al. Adjuvant nivolumab vs placebo for high-risk muscle-invasive urothelial carcinoma: 5-year efficacy and ctDNA results from CheckMate 274. Presented at: 2025 European Society for Medical Oncology Congress. October 17-21, 2025. Berlin, Germany. Abstract 3068O