The following article features coverage from the ASCO Genitourinary Cancers Symposium 2022. Click here to read more of MPR‘s conference coverage.

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.

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.