Dr Michiel Simon van der Heijden talks to ecancer about data he presented at ASCO 2025 from the phase 3 CheckMate 901 trial.

This evaluated nivolumab plus ipilimumab (NIVO+IPI) versus gemcitabine-carboplatin chemotherapy in cisplatin-ineligible patients with previously untreated unresectable or metastatic urothelial carcinoma (mUC).

While the NIVO+IPI regimen showed a numerically longer median overall survival (19.1 vs 13.2 months; HR 0.79), it did not meet the prespecified threshold for statistical significance.

Despite this, the immunotherapy combination demonstrated durable responses and a favourable safety profile compared to chemotherapy, with fewer high-grade adverse events. These findings highlight the potential of a finite-duration, chemotherapy-free option for this challenging patient population, although further evidence is needed to support its widespread adoption as standard first-line treatment.