The first patient has been dosed in the TROPION-Urothelial04 phase 3 trial evaluating Datroway® (datopotamab deruxtecan) plus rilvegostomig or Datroway monotherapy versus current standard of care (durvalumab monotherapy or nivolumab monotherapy or enfortumab vedotin plus pembrolizumab) as an adjuvant treatment (after surgery) in patients with muscle invasive urothelial cancer (MIUC) at high risk of recurrence following radical surgical resection with or without prior neoadjuvant therapy.

Datroway is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (NYSE:AZN). Rilvegostomig is AstraZeneca’s anti-PD-1/TIGIT dual checkpoint inhibitor bispecific antibody.

MIUC is a highly progressive disease, representing approximately 30% of all urothelial cancer cases. While adjuvant immunotherapy remains standard of care in the muscle invasive setting, many patients still face a high risk for disease recurrence after surgery, underscoring the need for new treatments that can further improve long-term outcomes. There are currently no TROP2 directed medicines approved for the treatment of urothelial cancer.