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Thomas Flaig, MD
Thomas Flaig, MD
Posted: Monday, February 20, 2023
In April 2021, the U.S. Food and Drug Administration granted accelerated approval to the Trop2-directed antibody-drug conjugate sacituzumab govitecan-hziy for patients with metastatic urothelial cancer whose disease progressed after platinum-containing and checkpoint inhibitor therapies, based on data from cohort 1 of the phase II TROPHY-U-01 trial. The preliminary results from cohort 2 revealed an objective response rate of 28% with monotherapy in platinum-ineligible patients; Daniel P. Petrylak, MD, of Yale School of Medicine, New Haven, Connecticut, and colleagues reported the primary data during the 2023 American Society for Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium (Abstract 520).
“Sacituzumab govitecan monotherapy demonstrated a high response rate with an overall manageable safety profile,” the investigators remarked. “These data support further evaluation of sacituzumab govitecan in patients with metastatic urothelial cancer [who received prior] checkpoint inhibitor therapy.”
A total of 38 patients whose disease progressed after checkpoint inhibition were administered 10 mg/kg of sacituzumab govitecan on days 1 and 8 of 21-day cycles. Follow-up data were provided for a median of 9.3 months. Per central review, the objective response rate was 32%. The median duration of response was 5.6 months, and the median time to response was 1.4 months. The median durations of progression-free and overall survival were 5.6 and 13.5 months, respectively.
No new safety signals were observed, according to the investigators. Treatment-related adverse events of grade 3 or higher occurred in 68% of patients; neutropenia (34%), anemia (21%), leukopenia (18%), fatigue (18%), and diarrhea (16%) were reported most frequently. A total of 18% of patients discontinued treatment because of related adverse events. No treatment-related deaths were observed.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.
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