Daiichi Sankyo starts Datroway phase 3 cancer trial

• Daiichi Sankyo and AstraZeneca (NYSE:AZN) dosed the first patient in the TROPION-Urothelial04 phase 3 trial evaluating Datroway in muscle invasive urothelial cancer.
• The trial will compare Datroway combinations and monotherapy against current standard treatments in approximately 915 patients.
• The companies are evaluating Datroway and rilvegostomig as potential earlier-line treatments for patients at high risk of recurrence after surgery.

Daiichi Sankyo and AstraZeneca (NYSE:AZN) dosed the first patient in the phase 3 TROPION-Urothelial04 trial evaluating Datroway plus rilvegostomig or Datroway monotherapy in patients with high-risk muscle invasive urothelial cancer.

The trial will compare the treatments against current standard care options, including durvalumab monotherapy, nivolumab monotherapy, or enfortumab vedotin plus pembrolizumab, following surgical resection.

“Following the encouraging results in the urothelial cancer cohorts of the TROPION-PanTumor03 and TROPION-PanTumor01 trials, we are now evaluating the combination of Datroway and rilvegostomig in earlier lines of treatment for this disease,” said Abderrahmane Laadem, MD, Head, Therapeutic Area Oncology Development, Daiichi Sankyo.

The global phase 3 study will enroll approximately 915 patients and evaluate disease-free survival as the primary endpoint for Datroway plus rilvegostomig compared with standard care.

Datroway is a TROP2-directed DXd antibody drug conjugate discovered by Daiichi Sankyo and jointly developed and commercialized with AstraZeneca, while rilvegostomig is AstraZeneca’s anti-PD-1/TIGIT dual checkpoint inhibitor bispecific antibody.

Daiichi Sankyo and AstraZeneca are also evaluating Datroway in the phase 2/3 TROPION-Urothelial03 trial for patients with metastatic urothelial carcinoma after progression following enfortumab vedotin plus pembrolizumab treatment.