ESMO open · 2025
Phase II trial of enfortumab vedotin in patients with previously treated gastric and esophageal cancers.
СтатьяКлиническое исследование II фазыНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Muro K, Chin K, Maron S B, Braiteh F S, Mitani S, Hara H, Kuboki Y, Mulcahy M F, Baranda J C, Gardner F P, Jin N, Hamauchi S, Kaplan J, Gorla S, Liu S, Wozniak M, Poondru S, Dillon R, Meng C, Kondo S
Аннотация
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% and 45.5%, respectively. Median DOR, PFS, and OS were 3.9, 2.1, and 7.4 months, respectively. The most common all-grade TRAEs were pruritus (n = 12, 27.3%), rash maculopapular (n = 12, 27.3%), and dysgeusia (n = 11, 25.0%). Twelve patients (27.3%) experienced grade ≥3 TRAEs.
CONCLUSIONS: EV demonstrated antitumor activity in patients with predominantly heavily pretreated la/m GEA or ESCC. The predefined threshold for promising antitumor activity was met in patients with ESCC but not in those with GEA. Safety was manageable and consistent with previous reports.
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% and 45.5%, respectively. Median DOR, PFS, and OS were 3.9, 2.1, and 7.4 months, respectively. The most common all-grade TRAEs were pruritus (n = 12, 27.3%), rash maculopapular (n = 12, 27.3%), and dysgeusia (n = 11, 25.0%). Twelve patients (27.3%) experienced grade ≥3 TRAEs.
CONCLUSIONS: EV demonstrated antitumor activity in patients with predominantly heavily pretreated la/m GEA or ESCC. The predefined threshold for promising antitumor activity was met in patients with ESCC but not in those with GEA. Safety was manageable and consistent with previous reports.