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Thomas Flaig, MD


ASCO GU 2022: Interim Trial Results With Pembrolizumab Plus Sacituzumab Govitecan-hziy in Urothelial Cancer

By: Lauren Harrison, MS
Posted: Monday, March 7, 2022

Many patients with metastatic urothelial cancer responded to treatment with sacituzumab govitecan-hziy plus pembrolizumab, with reportedly manageable side effects. Sacituzumab govitecan is an antibody-drug conjugate made up of an antitrophoblast cell-surface antigen 2 antibody coupled to a topoisomerase-I inhibitor. Petros Grivas, MD, PhD, of the University of Washington, presented results from Cohort 3 of the TROPHY-U-01 trial at the 2022 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium (Abstract 434).

This cohort of the trial consisted of 41 patients with metastatic urothelial cancer who had experienced disease progression after one to three prior lines of platinum-based chemotherapy. These patients had not received prior checkpoint inhibitor treatment, and all had measurable disease. The recommended phase II dose of sacituzumab govitecan was 10 mg/kg, which was determined during a 10-patient safety lead-in. The rest of the patients were enrolled at the phase II dose.

The investigator-assessed objective response rate was 34% after a median follow-up of 5.8 months. One patient had a complete response to therapy, and 13 had a partial response. The clinical benefit rate was 44%, and the 6-month progression-free survival rate was 47%. The median time to response was 2 months.

The treatment-emergent adverse events reported most often included diarrhea (76%), nausea (56%), anemia (56%), neutropenia (44%), and asthenia (41%). Grade 3 adverse events were noted in 59% of patients, with the most common being diarrhea (24%), anemia (20%), febrile neutropenia (10%), fatigue (7%), and asthenia (5%). Two patients discontinued therapy due to treatment-related adverse events; however, no patients died as a result of the treatment.

Disclosure: For a full list of authors’ disclosures, visit

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