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TROPION-Urothelial04 Phase 3 Trial of Datroway® Initiated as Adjuvant Therapy in Patients with High-Risk Muscle Invasive Urothelial Cancer

TYO:4568AZN
  • The first patient has been dosed in the TROPION-Urothelial04 phase 3 trial evaluating Datroway plus rilvegostomig or Datroway monotherapy versus standard of care (durvalumab, nivolumab, or enfortumab vedotin plus pembrolizumab) as adjuvant treatment for high-risk muscle invasive urothelial cancer (MIUC).
  • Datroway is a TROP2-directed antibody-drug conjugate jointly developed by Daiichi Sankyo and AstraZeneca, while rilvegostomig is AstraZeneca's anti-PD-1/TIGIT dual checkpoint inhibitor bispecific antibody.
  • TROPION-Urothelial04 is a global, multicenter, three-arm open-label trial that will enroll approximately 915 patients across Asia, Europe, North America, Oceania, and South America in a 2:1:2 randomization ratio.
  • The primary endpoint of the trial is disease-free survival (DFS) assessed by the investigator for the combination of Datroway and rilvegostomig versus standard of care.
  • Key secondary endpoints include DFS by blinded independent central review, disease-specific survival, recurrence-free survival, distant metastasis-free survival, patient-reported outcomes, overall survival, and safety.
  • No TROP2-directed medicines are currently approved for the treatment of urothelial cancer, despite MIUC representing approximately 30% of all urothelial cancer cases with high recurrence risks after surgery.
  • Datroway is already approved in over 30 countries for triple-negative breast cancer, in over 45 countries for HR-positive/HER2-negative breast cancer, and in Brazil, Russia, Singapore, and the U.S. for EGFR-mutated non-small cell lung cancer.
  • Warnings for Datroway include severe, life-threatening, or fatal interstitial lung disease/pneumonitis, ocular adverse reactions such as keratitis, stomatitis, and embryo-fetal toxicity due to the DXd payload.
  • A separate TROPION-Urothelial03 phase 2/3 trial is evaluating Datroway plus platinum-based chemotherapy versus gemcitabine and platinum-based chemotherapy in patients with metastatic urothelial carcinoma who progressed after enfortumab vedotin plus pembrolizumab.
  • The TIGIT component of rilvegostomig is derived from the clinical-stage anti-TIGIT antibody COM902 developed by Compugen Ltd.
  • Daiichi Sankyo and AstraZeneca entered a global collaboration in July 2020 to jointly develop and commercialize Datroway, except in Japan where Daiichi Sankyo holds exclusive rights.