研究者情報

キクチ　エイジ   KIKUCHI EIJI   菊地栄次    所属   医学部医学科 腎泌尿器外科学    職種   主任教授
言語種別	日本語
発表タイトル	EV-302: enfortumab vedotin + pembrolizumab (EV+P) vs chemotherapy (chemo) in locally advanced or metastatic urothelial carcinoma (la/mUC) – updated analysis
会議名	第112回日本泌尿器科学会総会
学会区分	全国規模の学会
発表形式	口頭
講演区分	シンポジウム・ワークショップ・パネル（その他）
発表者・共同発表者	Kikuchi Eiji, Powles B. Thomas,Van Der Heijden S. Michiel, Loriot Yohann, Bedke Jens, Pérez Valderrama Begoña, Iyer Gopakumar, Hoffman-Censits Jean, Vulsteke Christof, Drakaki Alexandra, Rausch Steffen, Arafat Waddah, Park Se Hoon, Swami Umang, Li Jian-Ri, Gorla Seema, Moreno Blanca Homet, Yu Xuesong, Lu Yi-Tsung, Gupta Shilpa
発表年月日	2025/04/19
開催地 （都市, 国名）	福岡県福岡市
開催期間	2025/04/17～2025/04/19
国際共著	国際共著
概要	Objectives In EV-302 (NCT04223856), first-line (1L) EV+P significantly prolonged PFS and OS vs chemo in patients (pts) with la/mUC. We present 12 mos' additional follow-up and an exploratory analysis of confirmed complete response (cCR). Methods Pts with la/mUC were randomized 1:1 to receive 1L EV (1.25 mg/kg; D1 and D8; IV) +P (200 mg; D1; IV) or gemcitabine+cisplatin/carboplatin every 3 wks. Dual primary endpoints: PFS by BICR and OS. Select secondary endpoints: confirmed ORR (cORR), DOR, and safety. Exploratory analysis: outcomes in pts with cCR. Results In total, 442 pts were randomized to EV+P and 444 to chemo. At data cutoff (Aug 8, 2024), median follow-up was 29.1 mo (95% CI, 28.5-29.9). PFS by BICR (HR=0.48 [0.41-0.57]) and OS (HR=0.51 [0.43-0.61]) were prolonged with EV+P vs chemo. OS benefits were seen regardless of cisplatin eligibility or liver metastases. In response-evaluable pts, with EV+P vs chemo, respectively, cORR was 67.5% vs 44.2%, median DOR (95% CI) was 23.2 mo (17.8-NE) vs 7.0 mo (6.2-9.0), cCR was 30.4% vs 14.5%, and median duration of cCR was not reached vs 15.2 mo (95% CI, 10.3-NE). In the safety analysis set, grade ≧3 treatment-related (TR) adverse events with EV+P occurred in 57.3% (vs 69.5% with chemo) of pts overall and 61.7% (vs 71.9% with chemo) of pts with cCR; TR deaths occurred in 1.1% (vs 0.9% with chemo) of pts overall and none in pts with cCR. Conclusion Results show continued greater efficacy of EV+P vs chemo in a broad population, confirm durable efficacy of EV+P, and do not reveal new safety signals, reinforcing EV+P as SOC for 1L la/mUC.