At the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, Petros Grivas, MD, PhD, Fred Hutchinson Cancer Institute, Seattle, Washington, discussed sacituzumab govitecan with Michael Serzan, MD, Dana-Farber Cancer Institute, Boston, Massachusetts.
Sacituzumab govitecan, an antibody-drug conjugate against Trop-2, previously received FDA Accelerated Approval based on phase 2 data. However, the approval was voluntarily withdrawn after the phase 3 TROPiCS-03 trial did not meet its primary endpoint for patients with metastatic urothelial cancer.
“One of the major drawbacks [of TROPiCS-03] was low utilization of growth factor as primary prophylaxis, and there were many neutropenic events, grade 5 events, that happened in the sacituzumab arm,” Dr. Grivas said.
Despite the withdrawal, data from the SURE-02 and JAVELIN Bladder Medley trials presented at ASCO support the anticancer activity of sacituzumab govitecan, and the National Comprehensive Cancer Network guidelines still include it as a treatment option for metastatic urothelial cancer.
Dr. Grivas suggested he might use sacituzumab govitecan with growth factor support in carefully selected patients after exhausting other life-prolonging therapies. “Of course, it merits a discussion with the patient about pros and cons and benefits and risks in the context of this data we discussed today,” he added.
Additional trials are being considered for combinations of sacituzumab govitecan and immunotherapies in metastatic urothelial cancer, Dr. Grivas explained.
Sacituzumab govitecan has been FDA approved for several breast cancer indications.
