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. 2025 Oct 7:oyaf342.
doi: 10.1093/oncolo/oyaf342. Online ahead of print.

Efficacy of erdafitinib before or after enfortumab vedotin in FGFR3-altered advanced urothelial cancer: analysis of the UNITE collaborative study

Cindy Y Jiang  1 , Hyunsoo Hwang  1 , Ilana Y Epstein  2 , Dimitra Rafailia Bakaloudi  3 , Rafee Talukder  4 , Amy K Taylor  5 , Amanda Nizam  6 , Tanya Jindal  7 , Michael J Glover  8 , Ali Raza Khaki  8 , Pedro C Barata  9 , Charles B Nguyen  10 , Eugene Oh  11 , Nancy B Davis  12 , Hannah Mabey  13 , Christopher J Hoimes  14 , Sean T Evans  15 , Bashar Abuqayas  16 , Emily Lemke  17 , Irene Tsung  11 , Wei Qiao  1 , Deepak Kilari  17 , Yousef Zakharia  16 , Mehmet A Bilen  15 , Matthew I Milowsky  13 , Sumit A Shah  8 , Shilpa Gupta  6 , Hamid Emamekhoo  5 , Joaquim Bellmunt  2 , Ajjai S Alva  11 , Petros Grivas  3 , Pavlos Msaouel  1 , Vadim S Koshkin  7 , Matthew T Campbell  1 , Omar Alhalabi  1
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Free article

Efficacy of erdafitinib before or after enfortumab vedotin in FGFR3-altered advanced urothelial cancer: analysis of the UNITE collaborative study

Cindy Y Jiang et al. Oncologist. .
Free article

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.

Implications for practice: 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.

Keywords: FGFR3; advanced urothelial carcinoma; bladder cancer; enfortumab vedotin; erdafitinib.

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