Dr. Powles on Design and Findings of the BISCAY Trial in Platinum-Refractory Urothelial Cancer

Thomas Powles, MD, MBBS, MRCP, professor, Genitourinary Oncology, lead for Solid Tumour Research, and director, Barts Cancer Institute, discusses the design and findings of the phase Ib BISCAY trial in advanced, platinum-refractory urothelial cancer.

In the BISCAY trial, investigators evaluated personalized combination therapy with durvalumab (Imfinzi) in patients with platinum-refractory urothelial cancer. Investigators used FoundationOne CDx analysis to identify patients with FGFR alterations, BRCA1/2, ATM, homologous recombination repair gene alterations, and TSC1/2 and RICTOR gene alterations.

Patients were then enrolled into one of the following cohorts according to their gene profile: durvalumab plus the FGFR inhibitor AZD4547 (FGFR alterations), durvalumab plus olaparib (Lynparza; BRCA1/2, ATM, and homologous recombination repair gene alterations and unselected patients), durvalumab plus the dual mTORC1/2 inhibitor vistusertib (TSC1/2 and RICTOR gene alterations), durvalumab monotherapy, or durvalumab plus danvatirsen (no gene alterations).

The objective response rates (ORR) in these arms ranged from 27.6% to 35.7%. Although no one arm met the prespecified endpoint of a 50% ORR, Powles is hopeful that it sets a precedent for novel clinical trial designs.