European journal of cancer (Oxford, England : 1990) · 2025
Enfortumab vedotin in patients with advanced non-small cell lung cancer after disease progression on platinum- and PD-1/PD-L1 inhibitor-containing regimens: Phase 2 international multicenter EV-202 study.
СтатьяМногоцентровое исследованиеКлиническое исследование II фазыНазвание и аннотация: Перевод пока не подготовлен
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Muro Kei, Feinstein Trevor, Baranda Joaquina, Bonta Ioana, Yanagitani Noriko, Gersten Todd, Gandhi Leena, Kudo Toshihiro, Fujioka Naomi, Kaplan Jason, Gorla Seema, Liu Shubin, Wozniak Michele, Poondru Srinivasu, Dillon Ryan, Meng Changting, Patil Tejas
Аннотация
PURPOSE: Enfortumab vedotin (EV), a novel antibody-drug conjugate directed against Nectin-4, was explored in patients with non-small cell lung cancer (NSCLC) in cohorts 3 and 4 of the open-label, multicohort, Phase 2 EV-202 study (NCT04225117).
METHODS: Patients with squamous and non-squamous NSCLC previously treated with platinum and PD-1/L1 inhibitors received EV 1.25 mg/kg intravenously on days 1, 8, and 15 of 28-day cycles. A Bayesian optimal design for Phase 2 was used, with interim analysis (IA) conducted when 20 patients were response-evaluable by investigator assessment. Primary endpoint was confirmed objective response rate (ORR). Secondary endpoints included duration of response, disease control rate, progression-free survival (PFS), overall survival (OS), and safety. Of 40 patients, ≥ 7 and ≥ 10 responders were needed at final analysis to claim promising antitumor activity in squamous and non-squamous cohorts, respectively.
RESULTS: Sixty-six patients were enrolled: 23 in squamous, 43 in the non-squamous cohort. One patient in the squamous cohort achieved a response at IA; thus, enrollment was closed. In the non-squamous cohort, 6 patients achieved partial response (ORR [95 % CI], 14.0 % [5.3-27.9 %]) at final analysis; median (95 % CI) PFS and OS were 4.1 (2.8-5.7) and 10.5 (8.1-13.1) months, respectively. Most common treatment-related adverse events (≥30 % patients) in the non-squamous cohort were rash maculopapular and peripheral sensory neuropathy (37.2 % each); pruritus (34.9 %); and alopecia (32.6 %).
CONCLUSIONS: Although the predefined efficacy thresholds were not met in either cohort, the antitumor activity of EV in non-squamous NSCLC may support the option for further investigation in this population.
METHODS: Patients with squamous and non-squamous NSCLC previously treated with platinum and PD-1/L1 inhibitors received EV 1.25 mg/kg intravenously on days 1, 8, and 15 of 28-day cycles. A Bayesian optimal design for Phase 2 was used, with interim analysis (IA) conducted when 20 patients were response-evaluable by investigator assessment. Primary endpoint was confirmed objective response rate (ORR). Secondary endpoints included duration of response, disease control rate, progression-free survival (PFS), overall survival (OS), and safety. Of 40 patients, ≥ 7 and ≥ 10 responders were needed at final analysis to claim promising antitumor activity in squamous and non-squamous cohorts, respectively.
RESULTS: Sixty-six patients were enrolled: 23 in squamous, 43 in the non-squamous cohort. One patient in the squamous cohort achieved a response at IA; thus, enrollment was closed. In the non-squamous cohort, 6 patients achieved partial response (ORR [95 % CI], 14.0 % [5.3-27.9 %]) at final analysis; median (95 % CI) PFS and OS were 4.1 (2.8-5.7) and 10.5 (8.1-13.1) months, respectively. Most common treatment-related adverse events (≥30 % patients) in the non-squamous cohort were rash maculopapular and peripheral sensory neuropathy (37.2 % each); pruritus (34.9 %); and alopecia (32.6 %).
CONCLUSIONS: Although the predefined efficacy thresholds were not met in either cohort, the antitumor activity of EV in non-squamous NSCLC may support the option for further investigation in this population.