Phase II trial of enfortumab vedotin in patients with previously treated gastric and esophageal cancers

作者：K. Muro, Keisho Chìn, Steven B. Maron, Fadi S. Braiteh, Seiichiro Mitani, H. Hara, Yuko Kuboki, Mary F. Mulcahy, Joaquina Baranda, F P Gardner, Ning Jin, Satoshi Hamauchi, Jason Kaplan, Seema Rao Gorla, Sheng Liu, Marcin Woźniak, Srinivasu Poondru, Ryan Dillon, Changting Meng, Soichiro Kondo · 发表于：ESMO Open · 年份：2025 · DOI：10.1016/j.esmoop.2025.105806 · 被引用次数：4 · 研究领域：HER2/EGFR in Cancer Research、Gastric Cancer Management and Outcomes、Skin and Cellular Biology Research

BACKGROUND: Enfortumab vedotin (EV), a Nectin-4-directed antibody-drug conjugate, was evaluated in patients with solid tumors in EV-202 (NCT04225117), a multicohort, open-label, phase II study. MATERIALS AND METHODS: The gastroesophageal adenocarcinoma (GEA) or esophageal squamous cell carcinoma (ESCC) cohorts from EV-202 included adults with predominantly heavily pretreated locally advanced or metastatic (la/m) GEA or ESCC, respectively. Patients received EV 1.25 mg/kg intravenously on days 1, 8, and 15 of each 28-day cycle. The primary endpoint was investigator-assessed confirmed objective response rate (ORR) per RECIST v1.1. Secondary endpoints included duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety. Of 40 response-assessable patients, ≥7 (≥17.5%) per cohort were required to declare promising antitumor activity. RESULTS: In the GEA cohort, 42 patients (71.4% male; median age 62 years) received EV (median follow-up 11.1 months). Confirmed ORR and DCR were 9.5% and 47.6%, respectively. Median DOR, PFS, and OS were 10.3, 3.1, and 8.3 months, respectively. The most common all-grade treatment-related adverse events (TRAEs) were pruritus (n = 16, 38.1%), alopecia (n = 15, 35.7%), and dysgeusia (n = 13, 31.0%). Twelve patients (28.6%) experienced grade ≥3 TRAEs. In the ESCC cohort, 44 patients (81.8% male; median age 66 years) received EV (median follow-up not estimable). Confirmed ORR and DCR were 18.2% ...