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

IF 4.2 2区医学 Q1 ONCOLOGY

Oncologist Pub Date : 2025-10-07 DOI:10.1093/oncolo/oyaf342

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

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引用次数: 0

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.

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厄达非替尼治疗fgfr3改变的晚期尿路上皮癌的疗效：UNITE合作研究的分析

背景：Erdafitinib被批准用于局部晚期/转移性尿路上皮癌（LA/mUC）。随着强制维多汀（EV）联合派姆单抗（pembrolizumab）进入一线治疗，厄达非替尼在EV前和EV后的结果与临床相关，但在临床试验中没有具体评估。方法：UNITE是一项多机构回顾性研究，研究对象是接受新型靶向药物治疗的LA/mUC患者。所有FGFR3改变的患者均接受EV、埃尔达非替尼然后EV （Erda->EV）和EV然后埃尔达非替尼（EV->Erda）治疗。不需要用EV和Erda进行序贯治疗。主要终点是观察到的缓解率（ORR）和无进展生存期（PFS）；次要终点为总生存期（OS）。结果：我们确定了83例FGFR3改变患者，并将其分为三个队列：EV仅（n = 44）， Erda->EV （n = 24）和EV->Erda （n = 15）。大多数（72%）患者在接受厄达非替尼（检查点抑制剂[87%]，铂基化疗[64%]）之前接受了≥2线治疗。埃达非替尼治疗EV-naïve队列的中位PFS为7.5个月，ev治疗队列的中位PFS为4.0个月（HR 0.78; 95% CI 0.35-1.7）。厄达非替尼治疗EV-naïve的ORR为33%，ev治疗的ORR为31% （OR 1.1; 95%CI 0.29-4.1）。erdafitinib-naïve组EV患者的中位PFS为6个月，厄达非替尼组为5.3个月（HR 0.61; 95%CI 0.34-1.09）。erdafitinib-naïve组EV的ORR为54%，厄达非替尼组EV的ORR为32% （OR为2.5;95%CI 0.87-6.3）。结论：在fgfr3改变的LA/mUC患者中，厄达非替尼在ev前和ev后均具有活性。厄达非替尼的结果与更广泛一线使用EV之前产生的临床试验数据一致。研究结果是假设产生和考虑到小样本量应谨慎解释。实践意义：厄达非替尼治疗fgfr3改变的局部晚期/转移性尿路上皮癌的非试验结果与报道的临床试验数据一致。厄达非替尼治疗在房颤前和房颤后均有效。

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来源期刊

Oncologist 医学-肿瘤学

CiteScore

10.40

自引率

3.40%

发文量

309

审稿时长

3-8 weeks

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