Real-world clinical outcomes of sacituzumab govitecan after prior exposure to enfortumab vedotin in patients with metastatic urothelial carcinoma Journal Article
| Authors: | Sternschuss, M.; Toumbacaris, N.; Das, J. P.; Powles, T.; Kotecha, R. R.; Laccetti, A. L.; Xiao, H.; Feld, E.; McHugh, D. J.; Keegan, N. M.; Bajorin, D. F.; Funt, S. A.; Shah, N. J.; Iyer, G.; Aggen, D. H.; Teo, M. Y.; Ostrovnaya, I.; Rosenberg, J. E. |
| Article Title: | Real-world clinical outcomes of sacituzumab govitecan after prior exposure to enfortumab vedotin in patients with metastatic urothelial carcinoma |
| Abstract: | Background: Sacituzumab govitecan (SG) is an antibody–drug conjugate associated with clinically meaningful responses as advanced-line treatment of metastatic urothelial carcinoma (mUC). Practically, SG has been most commonly used in the post-enfortumab vedotin (EV) setting, but data are scarce regarding the efficacy in this population, including the negative phase III study that enrolled mostly EV-naive patients. Patients and methods: This was a single-center retrospective cohort of patients with mUC treated with SG after prior exposure to EV between April 2021 and November 2023. Clinical data were collected by chart review. Response to SG [complete response (CR), partial response (PR) and stable disease (SD)] was the primary endpoint and confirmed by radiologist evaluation using RECIST v1.1. Progression-free survival (PFS) and overall survival (OS) were calculated using the Kaplan–Meier method. Results: A total of 82 patients were identified. Median age was 71 years, 70% were male, 37% had upper tract primaries and 93% had visceral disease. The median number of prior treatment lines was 3 (range 1-8), and 68% received SG directly after EV. The observed response rate (ORR) was 11% [95% confidence interval (CI) 5.2% to 20%], with no CRs; median PFS was 2.1 months (95% CI 1.9-2.5 months), and median OS was 6.0 months (95% CI 4.5-6.9 months). There was no association between response to EV and outcomes with SG. Sequencing SG directly after EV was associated with improved ORR (P = 0.024) and PFS (hazard ratio 0.46, P = 0.019) but not OS. Primary prophylactic granulocyte colony-stimulating factor was administered in 70% of patients and was not associated with lower risk of neutropenia. G3-4 neutropenia and anemia each occurred in 36% of patients. Adverse events leading to SG discontinuation occurred in 5% of patients; there were no treatment-related deaths. Conclusions: SG resulted in limited clinical efficacy in our large cohort of real-world advanced mUC patients with prior exposure to EV. © 2025 The Authors |
| Keywords: | controlled study; treatment response; aged; major clinical study; overall survival; fatigue; neutropenia; squamous cell carcinoma; diarrhea; drug dose reduction; drug efficacy; drug withdrawal; monotherapy; systemic therapy; bone metastasis; chemotherapy; follow up; lymph node metastasis; progression free survival; antineoplastic metal complex; anemia; bone marrow suppression; blood toxicity; thrombocytopenia; cohort analysis; medical record review; retrospective study; fibroblast growth factor receptor 3; histology; febrile neutropenia; liver metastasis; lung metastasis; prophylaxis; brain metastasis; liver function test; dna topoisomerase inhibitor; disease control; transitional cell carcinoma; granulocyte colony stimulating factor; disease exacerbation; metastatic urothelial carcinoma; phase 3 clinical trial (topic); clinical outcome; septic shock; immune checkpoint inhibitor; response evaluation criteria in solid tumors; human; male; female; article; pembrolizumab; erdafitinib; non st segment elevation myocardial infarction; ecog performance status; microwave thermotherapy; antibody drug conjugate; enfortumab vedotin; sacituzumab govitecan; trastuzumab deruxtecan; antibody–drug conjugate; evidence gap |
| Journal Title: | ESMO Open |
| Volume: | 10 |
| Issue: | 6 |
| ISSN: | 2059-7029 |
| Publisher: | European Society for Medical Oncology |
| Date Published: | 2025-06-01 |
| Start Page: | 105305 |
| Language: | English |
| DOI: | 10.1016/j.esmoop.2025.105305 |
| PROVIDER: | scopus |
| PMCID: | PMC12173038 |
| PUBMED: | 40479863 |
| DOI/URL: | |
| Notes: | Article -- MSK Cancer Center Support Grant (P30 CA008748) acknowledged in PDF -- MSK corresponding author is Jonathan Rosenberg -- Source: Scopus |
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