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Clinical Trial
. 2025 Sep 9:227:115603.
doi: 10.1016/j.ejca.2025.115603. Epub 2025 Jul 9.

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

Kei Muro  1 , Trevor Feinstein  2 , Joaquina Baranda  3 , Ioana Bonta  4 , Noriko Yanagitani  5 , Todd Gersten  6 , Leena Gandhi  7 , Toshihiro Kudo  8 , Naomi Fujioka  9 , Jason Kaplan  10 , Seema Gorla  10 , Shubin Liu  10 , Michele Wozniak  10 , Srinivasu Poondru  10 , Ryan Dillon  10 , Changting Meng  11 , Tejas Patil  12
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Free article
Clinical Trial

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

Kei Muro et al. Eur J Cancer. .
Free article

Abstract

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.

Keywords: Antibody–drug conjugate; Efficacy; Enfortumab vedotin; Nectin-4; Non-small cell lung cancer; Safety.

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Conflict of interest statement

Declaration of Competing Interest Kei Muro: received personal fees from Taiho. Trevor Feinstein: speaker for AstraZeneca, Sanofi and Sobi; leadership role in One Oncology chair lung cancer. Joaquina Baranda: received research funding to institution from Astellas, AstraZeneca, Intellicrown, Pharm, Exelixis, and Genentech; owns stocks at Moderna, Zymeworks, Merus, Novo Nordisk, Aprea. Ioana Bonta: received consulting fees from Regeneron; honoraria from AstraZeneca, Daiichi-Sankyo, and Jenson Scientific. Noriko Yanagitani: received consulting fee from Chugai and payment or honoraria for lectures from AstraZeneca, Bayer, Bristol Myers Squibb, Chugai, Eli Lilly, Ono, Pfizer, and Takeda. Todd Gersten: no conflicts of interest. Leena Gandhi: no conflicts of interest. Toshihiro Kudo: no conflicts of interest. Naomi Fujioka: advisory board for AstraZeneca. Jason Kaplan: employee of Astellas. Seema Gorla: employee of Astellas. Shubin Liu: employee of Astellas. Michele Wozniak: employee of Astellas. Srinivasu Poondru: employee of Astellas. Ryan Dillon: employee of Astellas. Changting Meng: employee of Pfizer and may own stock options. Tejas Patil: received grants from Janssen and Gilead; consulting fees from AstraZeneca, Aadi Bioscience, Boehringer Ingelheim, Bristol Myers Squibb, Bicara, Caris, Daiichi-Sankyo, Foundation Medicine, Gilead, Merus, Janssen, Mirati Therapeutics, Pfizer, Sanofi, Regeneron, Roche/Genentech, and Takeda; others from Elevation Oncology.

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