Faculty Collaboration Database

Efficacy of erdafitinib before or after enfortumab vedotin in FGFR3-altered advanced urothelial cancer: analysis of the UNITE collaborative study. Oncologist 2025 Nov 11;30(11)

Date

10/07/2025

Pubmed ID

41056445

Pubmed Central ID

PMC12605803

DOI

10.1093/oncolo/oyaf342

Scopus ID

2-s2.0-105021481152 (requires institutional sign-in at Scopus site)

Abstract

BACKGROUND: Erdafitinib is approved for locally advanced/metastatic urothelial cancer (LA/mUC). As enfortumab vedotin (EV) plus pembrolizumab enters frontline management, outcomes with erdafitinib pre- and post-EV are clinically relevant but not specifically evaluated in clinical trials.

METHODS: UNITE is a multi-institutional retrospective study of patients with LA/mUC treated with novel targeted agents. All patients with FGFR3 alterations treated with EV only, erdafitinib then EV (Erda->EV), and EV then erdafitinib (EV->Erda) were included. Sequential treatment with EV and Erda was not required. Primary endpoints were observed response rates (ORR) and progression-free survival (PFS); secondary endpoint was overall survival (OS).

RESULTS: We identified 83 patients with FGFR3 alterations and separated them into three cohorts: EV only (n = 44), Erda->EV (n = 24), and EV->Erda (n = 15). Most (72%) received ≥2 lines of therapy before erdafitinib (checkpoint inhibitor [87%], platinum-based chemotherapy [64%]). Median PFS with erdafitinib for EV-naïve cohort was 7.5 months and in EV-treated cohort 4.0 months (HR 0.78; 95% CI 0.35-1.7). ORR with erdafitinib for EV-naïve was 33% and EV-treated 31% (OR 1.1; 95% CI 0.29-4.1). Median PFS with EV for patients who were erdafitinib-naïve was 6 months and in erdafitinib-treated 5.3 months (HR 0.61; 95% CI 0.34-1.09). ORR with EV was 54% in erdafitinib-naïve cohort and 32% in erdafitinib-treated cohort (OR 2.5; 95% CI 0.87-6.3).

CONCLUSION: In patients with FGFR3-altered LA/mUC, erdafitinib is active pre- and post-EV. Outcomes with erdafitinib were consistent with clinical trial data generated prior to broader frontline use of EV. Findings are hypothesis-generating and given small sample size should be interpreted with caution.

Author List

Jiang CY, Hwang H, Epstein IY, Bakaloudi DR, Talukder R, Taylor AK, Nizam A, Jindal T, Glover MJ, Khaki AR, Barata PC, Nguyen CB, Oh E, Davis NB, Mabey H, Hoimes CJ, Evans ST, Abuqayas B, Lemke E, Tsung I, Qiao W, Kilari D, Zakharia Y, Bilen MA, Milowsky MI, Shah SA, Gupta S, Emamekhoo H, Bellmunt J, Alva AS, Grivas P, Msaouel P, Koshkin VS, Campbell MT, Alhalabi O

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

Adult
Aged
Aged, 80 and over
Antibodies, Monoclonal
Antineoplastic Combined Chemotherapy Protocols
Female
Humans
Male
Middle Aged
Pyrazoles
Quinoxalines
Receptor, Fibroblast Growth Factor, Type 3
Retrospective Studies
Urologic Neoplasms