This prospective, phase 2, single-arm study enrolled patients with good PS (ECOG 0-1) who have advanced urothelial carcinoma or variant histologies who have failed platinum-based chemotherapy to combination DURVA and CABO. The primary endpoint was overall survival. The authors present an interim analysis of 15 enrolled patients as of June 2020. Treatment-related adverse events (AEs) occurred in 13 patients (87%). However, no patients discontinued durvalumab treatment and cabozantinib discontinuation was only necessary in 1 patient. At a median follow-up of 5 months, 1 patient had a complete radiographic response and 4 patients exhibited partial responses according to RECIST criteria. The figure (below) depicts a patient with high-volume bony metastases who exhibited promising FDG PET response as well as a reduction in circulating tumor DNA after combination treatment. The authors conclude that combination durvalumab and cabozantinib demonstrate encouraging clinical activity with a manageable safety profile in patients with advanced urothelial carcinoma at this interim analysis.
Presented by: Laura Marandino, MD, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy
Written by: Dr. Patrick Hensley, Urologic Oncology Fellow at MD Anderson Cancer Center, Twitter: @pjhensley11, with Ashish Kamat, MD, MBBS, President of The International Bladder Cancer Network (IBCN), The International Bladder Cancer Group (IBCG), and Professor of the Department of Urology, Division of Surgery, The University of Texas MD Anderson Cancer Center, Houston, Texas, Twitter: @UroDocAsh, at the International Bladder Cancer Network (IBCN) Annual Meeting, #IBCN2020, October 17, 2020.