Treatment with sacituzumab govitecan in combination with pembrolizumab appears to be beneficial for patients with metastatic urothelial cancer who have progressed after platinum-based regimens, according to interim findings from cohort 3 of the TROPHY-U-01 trial presented at the 2022 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium.

Cohort 3 of the phase 2, open-label TROPHY-U-01 trial (ClinicalTrials.gov Identifier: NCT03547973) evaluated the efficacy and safety of sacituzumab govitecan, a Trop-2 directed antibody and topoisomerase inhibitor conjugate, plus pembrolizumab, a programmed death receptor-1 (PD-1)-blocking antibody, in checkpoint inhibitor-naive adults with metastatic urothelial cancer who progressed after platinum-based chemotherapy.

Patients received sacituzumab govitecan 10mg/kg intravenously (IV) on days 1 and 8 of a 21-day cycle and pembrolizumab 200mg IV only on day 1 of a 21-day cycle. The primary endpoint was overall response rate (ORR), as assessed by blinded independent central review per RECIST 1.1.


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At a median follow-up of 5.8 months, the ORR was 34% (95% CI, 20.1-50.6); 1 patient achieved complete response and 13 achieved partial response. The clinical benefit rate, defined as complete response + partial response + stable disease for at least 6 months, was 44% (95% CI, 28.5-60.3), while the 6-month progression-free survival rate was 47%. The median time to response was reported to be 2 months (95% CI, 1.3-2.8).

As for safety, the most common adverse events related to treatment included diarrhea (76%), nausea (59%), anemia (56%), neutropenia (44%), and asthenia (41%). Fifty-nine percent of patients reported grade 3 or greater treatment-emergent adverse events (eg, diarrhea, anemia, febrile neutropenia, fatigue, asthenia).

Study authors concluded that “[sacituzumab govitecan] in combination with [pembrolizumab] demonstrated encouraging ORR and CBR, with an overall manageable safety profile with no new safety signal in [checkpoint inhibitor]-naive [patients] who progressed after prior [platinum]-based chemotherapy.”

Study limitations included small sample size, short follow-up and lack of randomization.

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

Reference

Grivas P, Pouessel D, Park CH, et al. TROPHY-U-01 Cohort 3: Sacituzumab govitecan (SG) in combination with pembrolizumab (pembro) in patients (pts) with metastatic urothelial cancer (mUC) who progressed after platinum (PLT)-based regimens. Presented at: ASCO-GU 2022; February 17-19, 2022; Abstract 434.

This article originally appeared on MPR