Journal article
Efficacy of erdafitinib before or after enfortumab vedotin in FGFR3-altered advanced urothelial cancer: analysis of the UNITE collaborative study
The oncologist (Dayton, Ohio), Vol.30(11), oyaf342
11/2025
DOI: 10.1093/oncolo/oyaf342
PMCID: PMC12605803
PMID: 41056445
Abstract
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.
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).
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).
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.
Non-trial outcomes of erdafitinib in FGFR3-altered locally advanced/metastatic urothelial cancer are consistent with reported clinical trial data. Erdafitinib therapy is effective in the pre- and post- EV setting.
Details
- Title: Subtitle
- Efficacy of erdafitinib before or after enfortumab vedotin in FGFR3-altered advanced urothelial cancer: analysis of the UNITE collaborative study
- Creators
- Cindy Y Jiang - The University of Texas MD Anderson Cancer CenterHyunsoo Hwang - The University of Texas MD Anderson Cancer CenterIlana Y Epstein - Dana-Farber Cancer InstituteDimitra Rafailia Bakaloudi - University of WashingtonRafee Talukder - Baylor College of MedicineAmy K Taylor - University of Wisconsin Carbone Cancer CenterAmanda Nizam - Cleveland ClinicTanya Jindal - University of California, San FranciscoMichael J Glover - Stanford UniversityAli Raza Khaki - Stanford UniversityPedro C Barata - University Hospitals Seidman Cancer CenterCharles B Nguyen - City Of Hope National Medical CenterEugene Oh - Michigan Center for Translational PathologyNancy B Davis - Vanderbilt UniversityHannah Mabey - University of North Carolina at Chapel HillChristopher J Hoimes - Duke Medical CenterSean T Evans - Emory UniversityBashar Abuqayas - University of IowaEmily Lemke - Medical College of WisconsinIrene Tsung - Michigan Center for Translational PathologyWei Qiao - The University of Texas MD Anderson Cancer CenterDeepak Kilari - Medical College of WisconsinYousef Zakharia - University of IowaMehmet A Bilen - Emory UniversityMatthew I Milowsky - University of North Carolina at Chapel HillSumit A Shah - Stanford UniversityShilpa Gupta - Cleveland ClinicHamid Emamekhoo - University of Wisconsin–MadisonJoaquim Bellmunt - Dana-Farber Cancer InstituteAjjai S Alva - University of MichiganPetros Grivas - University of WashingtonPavlos Msaouel - The University of Texas MD Anderson Cancer CenterVadim S Koshkin - University of California, San FranciscoMatthew T Campbell - The University of Texas MD Anderson Cancer CenterOmar Alhalabi - The University of Texas MD Anderson Cancer Center
- Resource Type
- Journal article
- Publication Details
- The oncologist (Dayton, Ohio), Vol.30(11), oyaf342
- DOI
- 10.1093/oncolo/oyaf342
- PMID
- 41056445
- PMCID
- PMC12605803
- NLM abbreviation
- Oncologist
- ISSN
- 1083-7159
- eISSN
- 1549-490X
- Publisher
- Oxford University Press
- Language
- English
- Electronic publication date
- 10/07/2025
- Date published
- 11/2025
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; General Internal Medicine; Internal Medicine
- Record Identifier
- 9985014993102771
Metrics
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