Faculty Collaboration Database

Efficacy of sacituzumab govitecan after enfortumab vedotin in advanced urothelial carcinoma: Analysis of the UNITE study. Urol Oncol 2026 Jan;44(1):65.e1-65.e11

Date

10/29/2025

Pubmed ID

41152111

DOI

10.1016/j.urolonc.2025.09.025

Scopus ID

2-s2.0-105024203120 (requires institutional sign-in at Scopus site)

Abstract

BACKGROUND: Sacituzumab govitecan (SG) is an antibody-drug conjugate used for advanced urothelial carcinoma (aUC) refractory to platinum-based chemotherapy and immune checkpoint inhibitors (ICI). Real-world data are needed to better define SG outcomes, particularly following treatment with enfortumab vedotin (EV). In this analysis, we aim to evaluate efficacy of SG after EV and assess putative biomarkers associated with outcomes.

METHODS: In the UNITE retrospective study, we identified patients who received ≥1 SG cycle after therapy with EV. Observed response rate (ORR) was assessed in evaluable patients and correlated with baseline clinical characteristics and biomarkers. ORRs were compared using logistic regression, while progression free survival (PFS) and overall survival (OS) from SG start were estimated via Kaplan-Meier and Cox proportional hazard (PH) model. Biomarkers of response were evaluated in multivariate Cox PH models after accounting for relevant clinical variables.

RESULTS: Among 107 patients treated with SG after EV, 97 (91%) had NGS data. Median age was 69 years, 73% were male, 33% had ≥4 prior lines of therapy, and 42% received G-CSF. ORR was 18% (95% CI: 10%-26%), median PFS 3.2 months, and median OS 6.0 months. In patients with disease control on EV, ORR was 22% compared to 8% in primary progressors on EV. No significant associations were found between molecular biomarkers and SG outcomes in the multivariate analysis.

CONCLUSION: SG showed modest activity after EV in heavily pretreated patients with aUC. ORR with SG after EV was lower than reported in phase 2 and phase 3 clinical trials for SG in the postplatinum/ICI setting.

Author List

Jindal T, Jiang CY, Alhalabi O, Davidsohn M, Freeman D, Epstein IY, Bakaloudi DR, Talukder R, Nizam A, Nguyen CB, Oh E, Tsung I, Glover MJ, Khaki AR, Taylor AK, Jaime-Casas S, Jang A, Lemke E, Pywell C, Evans ST, Shin D, Bilen MA, Basu A, Kilari D, Tripathi A, Brown J, Emamekhoo H, Davis NB, Shah S, Gupta S, Grivas P, Bellmunt J, Alva A, Campbell MT, Koshkin VS

Author

Deepak Kilari MD Associate Professor in the Medicine department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Aged
Aged, 80 and over
Antibodies, Monoclonal
Antibodies, Monoclonal, Humanized
Antineoplastic Combined Chemotherapy Protocols
Camptothecin
Carcinoma, Transitional Cell
Female
Humans
Immunoconjugates
Male
Middle Aged
Retrospective Studies
Treatment Outcome
Urinary Bladder Neoplasms
Urologic Neoplasms