Datroway phase 3 TROPION-Urothelial04 trial initiated as adjuvant therapy for high-risk MIUC

CAR-T Digest - August 2020

26 August 2026: Datroway phase 3 TROPION-Urothelial04 trial initiated as adjuvant therapy for high-risk MIUC

Daiichi Sankyo and AstraZeneca announced the initiation of the phase 3 TROPION-Urothelial04 trial, with the first patient dosed, evaluating Datroway plus rilvegostomig or Datroway monotherapy versus standard of care as adjuvant treatment for patients with high-risk muscle-invasive urothelial cancer following surgery

The global phase 3 trial will evaluate Datroway plus rilvegostomig or Datroway monotherapy against current standard treatments, with disease-free survival as the primary endpoint; approximately 915 patients will be enrolled across Asia, Europe, North America, Oceania and South America
The study addresses a major unmet need in muscle-invasive urothelial cancer, where approximately 30% of urothelial cancer cases are muscle-invasive and many patients remain at high risk of recurrence despite adjuvant immunotherapy following surgery
Datroway is a TROP2-directed ADC comprising a humanized anti-TROP2 IgG1 antibody linked to multiple topoisomerase I inhibitor DXd payloads through tetrapeptide-based cleavable linkers, enabling targeted delivery to TROP2-expressing tumor cells
Strategically, initiation of TROPION-Urothelial04 expands Datroway’s development into the adjuvant urothelial cancer setting, strengthens its positioning beyond breast and lung cancers, and further broadens Daiichi Sankyo and AstraZeneca’s global ADC development footprint across multiple regions

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