Sacituzumab govitecan can produce responses in patients with metastatic urothelial carcinoma who are ineligible for platinum-based therapies and whose disease progressed after checkpoint inhibitor therapy, a phase 2 study suggests.

Results from this study were presented at the 2023 ASCO Genitourinary Cancers Symposium by Daniel P. Petrylak, MD, of Yale School of Medicine in New Haven, Connecticut.

Dr Petrylak presented results from cohort 2 of the phase 2 TROPHY-U-01 trial ( Identifier: NCT03547973). This cohort included 38 patients with metastatic urothelial carcinoma who were ineligible for platinum-based chemotherapy and had disease progression after checkpoint inhibitor therapy.

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At baseline, the patients’ median age was 73 (range, 41-87) years, 61% were men, and 66% had distant metastasis. The patients had received a median of 2 (range, 1-5) prior cancer therapies. Prior systemic therapy produced a complete response in 3% of patients and a partial response in 16%.

Patients received sacituzumab govitecan at 10 mg/kg on days 1 and 8 every 21 days until disease progression or unacceptable toxicity.

The objective response rate was 32%. All responses were partial responses. The median duration of response was 5.6 months, and 2 patients had an ongoing response at the data cutoff.

The rate of stable disease was 34%. Four patients maintained stable disease for at least 6 months. The overall clinical benefit rate was 42%.

For the 13 patients who were naïve to platinum-based chemotherapy or enfortumab vedotin, the objective response rate was 53.8%.

In the overall cohort, the median follow-up was 9.3 months. The median progression-free survival was 5.6 months, and the median overall survival was 13.5 months.

Treatment-related adverse events (TRAEs) of any grade occurred in 63% of patients, and grade 3 or higher TRAEs occurred in 16%. The most common grade 3 or higher TRAEs were neutropenia (34%), anemia (21%), leukopenia (18%), fatigue (18%), and diarrhea (16%). There were no fatal TRAEs.

“These data support the further evaluation of sacituzumab govitecan, alone or in combination, for patients with metastatic urothelial carcinoma who progressed after checkpoints,” Dr Petrylak said.

He noted that cohorts 4, 5, and 6 of the TROPHY-U-01 trial are currently enrolling patients.

Disclosures: This research was supported by Gilead Sciences, Inc. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.


Petrylak DP, Tagawa ST, Jain RK, et al. Primary analysis of TROPHY-U-01 cohort 2, a phase 2 study of sacituzumab govitecan (SG) in platinum (PT)-ineligible patients (pts) with metastatic urothelial cancer (mUC) that progressed after prior checkpoint inhibitor (CPI) therapy. ASCO GU 2023. February 16-18, 2023. Abstract 520.

This article originally appeared on Cancer Therapy Advisor