DATROWAY (datopotamab deruxtecan) plus rilvegostomig - (TROPION-Urothelial04)

August 25, 2026: Daiichi Sankyo (TSE: 4568) and AstraZeneca (NYSE: AZN) announced the first patient was dosed in TROPION-Urothelial04, a global Phase 3 trial of Datroway (datopotamab deruxtecan) plus rilvegostomig, or Datroway alone, versus standard of care as adjuvant treatment after surgery for patients with high-risk muscle-invasive urothelial cancer following radical resection, with or without prior neoadjuvant therapy.

The three-arm, open-label study will randomize about 915 patients 2:1:2 across Asia, Europe, North America, Oceania, and South America. The primary endpoint is investigator-assessed disease-free survival for the Datroway plus rilvegostomig arm versus standard of care. Key secondary endpoints include blinded independent central review-assessed disease-free survival, disease-specific survival, non-urothelial tract recurrence-free survival, distant metastasis-free survival, patient-reported outcomes, overall survival, and safety.

The companies said this is their second pivotal Datroway trial in urothelial cancer. They also noted the ongoing TROPION-Urothelial03 Phase 2/3 trial, which is evaluating Datroway plus platinum-based chemotherapy versus gemcitabine plus platinum-based chemotherapy in metastatic urothelial carcinoma after progression on enfortumab vedotin plus pembrolizumab.