Dr. Sonpavde on Fixed-Dose Durvalumab and Tremelimumab Study in Urothelial Carcinoma

Guru Sonpavde, MD, director of Bladder Cancer at Dana-Farber Cancer Institute, discusses the phase IIIb safety study of fixed-dose durvalumab (Imfinzi) and tremelimumab in patients with advanced urothelial carcinoma during the 2018 Genitourinary Cancers Symposium.

The open-label, multicenter STRONG study is enrolling approximately 1200 patients with advanced disease in patients during or following nonplatinum or platinum-based therapy. What is novel about this study, Sonpavde says, is that patients receive durvalumab at a fixed-dosing schedule. In the study that led to durvalumab's May 2017 FDA approval in urothelial carcinoma, the single-arm phase I/II Study 1108, patients were treated with a weight-based dosing regimen of 10 mg/kg every 2 weeks.

This study includes separate cohorts of patients with durvalumab alone at a fixed-dose schedule of 1500 mg every 4 weeks. This is a flat dosing regardless of weight, he adds, which was seen in earlier studies to provide the same pharmacokinetics as weight-based dosing.

Once the durvalumab monotherapy cohort is established, investigators will study this fixed dose of durvalumab in combination with tremelimumab, which will also be given at a fixed dose every 4 weeks.