Pembrolizumab with or Without Lenvatinib as First-line Therapy for Patients with Advanced Urothelial Carcinoma (LEAP-011): A Phase 3, Randomized, Double-Blind Trial

Nobuaki Matsubara; Ronald de Wit; Arjun Vasant Balar; Arlene O Siefker-Radtke; Jakub Zolnierek; Tibor Csoszi; Sang Joon Shin; Se Hoon Park; Vagif Atduev; Mahmut Gumus 10; Yu-Li Su; Saziye Burcak Karaca; Hernán Javier Cutuli; Mehmet A N Sendur; Liji Shen; Karen O'Hara; Chinyere E Okpara; Sonia Franco; Blanca Homet Moreno; Petros Grivas; Yohann Loriot

doi:10.1016/j.eururo.2023.08.012

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Pembrolizumab with or Without Lenvatinib as First-line Therapy for Patients with Advanced Urothelial Carcinoma (LEAP-011): A Phase 3, Randomized, Double-Blind Trial

Authors: Nobuaki Matsubara ; Ronald de Wit ; Arjun Vasant Balar ; Arlene O Siefker-Radtke ; Jakub Zolnierek ; Tibor Csoszi ; Sang Joon Shin ; Se Hoon Park ; Vagif Atduev ; Mahmut Gumus 10 ; Yu-Li Su ; Saziye Burcak Karaca ; Hernán Javier Cutuli ; Mehmet A N Sendur ; Liji Shen ; Karen O'Hara ; Chinyere E Okpara ; Sonia Franco ; Blanca Homet Moreno ; Petros Grivas ; Yohann Loriot

Citation: EUROPEAN UROLOGY, Vol.85(3) : 229-238, 2024-03

Journal Title: EUROPEAN UROLOGY

ISSN: 0302-2838

Issue Date: 2024-03

MeSH: Antibodies, Monoclonal, Humanized / adverse effects ; Antineoplastic Combined Chemotherapy Protocols / adverse effects ; Carcinoma, Transitional Cell* / pathology ; Humans ; Phenylurea Compounds* ; Quinolines* ; Urinary Bladder Neoplasms* / drug therapy ; Urinary Bladder Neoplasms* / pathology

Keywords: Bladder cancer ; Checkpoint inhibitor ; Cisplatin Ineligible ; Immunotherapy ; Lenvatinib ; Pembrolizumab ; Platinum ineligible ; Urothelial carcinoma

Abstract: Background: Pembrolizumab plus lenvatinib has shown antitumor activity and acceptable safety in patients with platinum-refractory urothelial carcinoma (UC).

Objective: To evaluate pembrolizumab plus either lenvatinib or placebo as first-line

therapy for advanced UC in the phase 3 LEAP-011 study.

Design, setting, and participants: Patients with advanced UC who were ineligible for

cisplatin-based therapy or any platinum-based chemotherapy were enrolled.

Intervention: Patients were randomly assigned (1:1) to pembrolizumab 200 mg intravenously every 3 wk plus either lenvatinib 20 mg or placebo orally once daily.

Outcome measurements and statistical analysis: Dual primary endpoints were

progression-free survival (PFS) and overall survival (OS). An external data monitoring

committee (DMC) regularly reviewed safety and efficacy data every 3 mo.

Results and limitations: Between June 25, 2019 and July 21, 2021, 487 patients were allocated to receive lenvatinib plus pembrolizumab (n = 245) or placebo plus pembrolizumab (n = 242). The median time from randomization to the data cutoff date