Dr McGregor on the DAD-IO Trial of Sacituzumab Govitecan and EV in Metastatic Urothelial Carcinoma

“We’re looking to enroll [approximately] 42 patients with treatment-naive metastatic urothelial carcinoma ontothe phase 2 [portion of] the trial. [Patients will be] treated with enforrumab vedotin at 1.25 mg/kg and sacituzumab govitecan at 7.5 mg/kg on days 1 and 8, every 21 days.”

Bradley McGregor, MD, the Director of Clinical Research for the Lank Center of Genitourinary Oncology, an institute physician, and the Marra Lochiatto Investigator at Dana-Farber Cancer Institute, as well as an assistant professor of medicine at Harvard Medical School, discussed the background and key study features of the phase 1/2 DAD-IO trial (NCT04724018) evaluating sacituzumab govitecan-hziy (Trodelvy) in combination with enfortumab vedotin-ejfv (Padcev) in patients with metastatic urothelial carcinoma.

Antibody-drug conjugates (ADCs) have become a standard of care in bladder cancer and have revolutionized the treatment of patients with this disease, McGregor began. However, although ADCs have existed for some time, they had never been explored in combination i with each other for urothelial carcinoma until the phase 1 DAD trial (NCT04724018), which examined sacituzumab govitecan plus enfortumab vedotin in patients with metastatic urothelial carcinoma, he added.

Findings from DAD demonstrated that patients with metastatic urothelial carcinoma who experienced disease progression on platinum-based therapy and/or immunotherapy who received the combination (n = 23) achieved an overall response rate of 70% (95% CI, 47%-87%), McGregor said. Sacituzumab govitecan plus enfortumab vedotin also displayed a tolerable safety profile, he noted.

Data from DAD formed the rationale for initiating the DAD-IO trial, McGregor said. The study will enroll patients with treatment-naive metastatic urothelial carcinoma, he explained. The phase 2 portion of the study will enroll approximately 42 patients who will then receive enfortumab vedotin at 1.25 mg/kg and sacituzumab govitecan at 7.5 mg/kg on days 1 and 8, every 21 days, in addition to pembrolizumab (Keytruda), he added. During the expansion phase of the study, granulocyte colony-stimulating factor support will be strongly mandated per American Society of Clinical Oncology Guidelines, he concluded.