First-Line Lenvatinib Plus Pembrolizumab Versus Chemotherapy for Advanced Endometrial Cancer: A Randomized, Open-Label, Phase III Trial

医学 危险系数 伦瓦提尼 内科学 彭布罗利珠单抗 肿瘤科 卡铂 人口 化疗 癌症 顺铂 置信区间 环境卫生 免疫疗法 甲状腺癌
作者
Christian Marth,Richard G. Moore,Mariusz Bidziński,Sandro Pignata,Ali Ayhan,María Jesús Rubio,Mario Beiner,Marcia Hall,Christof Vulsteke,Elena Ioana Braicu,Kenzo Sonoda,Xiaohua Wu,Sophia Frentzas,André Mattar,Stéphanie Lheureux,Xiaojun Chen,Kosei Hasegawa,Manuel Magallanes-Maciel,Chel Hun Choi,Mariia Shalkova,Diego Kaen,Peng‐Hui Wang,Regina Berger,Chinyere E. Okpara,Jodi A. McKenzie,Lili Yao,Robert Orlowski,Vivek Khemka,Lucy Gilbert,Vicky Makker,Diego Kaen,G. Gomez Abuin,Liliana Zamora,Margarita Sonia Alfie,Ignacio Casarini,Michelle Harrison,Sumitra Ananda,Catherine Shannon,Sophia Frentzas,Michael Friedländer,Tarek Meniawy,Bo Gao,Sally Baron‐Hay,Connie I. Diakos,Christian Marth,Stephan Polterauer,Edgar Petru,Marlies De Bock,Christof Vulsteke,Jean‐François Baurain,Toon Van Gorp,Sevilay Altıntaş,João Paulo da Silveira Nogueira Lima,André Mattar,Ruffo Freitas‐Júnior,RO de Sant'ana,Andréia Cristina de Melo,Fábio Franke,Graziela Zibetti Dal Molin,Fernanda Damian,João Daniel Cardoso Guedes,Susan Ellard,Anna V. Tinker,Vanessa Samouëlian,Suzanne Fortin,Paul Bessette,Michael Kolinsky,Nidhi Kumar Tyagi,Josée-Lyne Ethier,Lucy Gilbert,Stéphanie Lheureux,Helen Mackay,Charles Henry Lim,Xiaohua Wu,Lingya Pan,Ruifang An,Xiaojun Chen,Hong Zheng,Yumei Wu,Jianqing Zhu,Shuzhong Yao,Xuemei Jia,Yi Huang,Weiguo Lv,Yu Zhang,Qi Zhou,Cailing Ma,Radoslav Chekerov,Paweł Mach,Ralf Witteler,F Marmé,Karen Cadoo,Jacob Korach,Talia Levy,Mario Beiner,Amnon Amit,Paolo Scollo,Emanuele Naglieri,Sandro Pignata,Claudio Zamagni,Vanda Salutari,Tomoka Usami,Kazuto Nakamura,Koji Matsumoto,Wataru Yamagami,Yoichi Kobayashi,Masashi Takano,Hidenori Kato,Kenzo Sonoda,Akira Kikuchi,Noriyuki Katsumata,Shoji Kamiura,Koji Horie,Kosei Hasegawa,Takuya Tsunoda,Nao Suzuki,Mayu Yunokawa,Shin Nishio,Wataru Kudaka,Francisco Cabrera,R. Mendoza,Manuel Ernesto Magallanes Maciel,Ricardo Villalobos-Valencia,Jose Escobar Penagos,Yamil Alonso Lopez Chuken,Beata Maćkowiak-Matejczyk,R. Tarnawski,Ewa Kalinka‐Warzocha,Mariusz Bidziński,Wiesława Bednarek,Anna Dańska-Bidzińska,P. Koralewski,A. Roszak,А. Г. Кедрова,Natalia E. Musaeva,А Ф Урманчеева,Aleksandr Vasiliev,Sufia Safina,Alla Lisyanskaya,I. V. Rykov,А. А. Rumyantsev,А. В. Белоногов,Yulia Makarycheva,Yong Man Kim,Chel Hun Choi,Yong Beom Kim,Hee Seung Kim,Sang Wun Kim,Marı́a Varela,Antonio Casado,Tamara Díaz Redondo,M.J. Rubio Pérez,Margarita Romeo,Ignacio Romero Noguera,Álvaro Taus Garcia,Wu-Chou Lin,Hung-Hsueh Chou,Wen‐Fang Cheng,Chien‐Hsing Lu,Peng‐Hui Wang,Tayup Şimşek,Fatih Köse,Ali Ayhan,Mehmet Ali Vardar,Kemal Özerkan,Alun D. Hughes,Alison Stillie,Gemma Eminowicz,Saira Khalique,Mariia Shalkova,Олена Миколаївна Сухіна,Tetiana Piatnytska,Hanna Averina,Yaroslav Kulyaba,Anna Kryzhanivska,Igor Bondarenko,V S Svintsitsky,Yuliia Krasnohrud,Олександр Войтко,Joseph Buscema,Sharad Ghamande,Sharyn N. Lewin,Deena M. Graham,Vicky Makker,Maria C. Bell,Alessandro D. Santin,Christine Lee,Stephanie V. Blank,Gottfried E. Konecny,Bradley R. Corr,Linda Van Le,Richard G. Moore,Jennifer Scalici,Charles E. Anderson,Patricia Braly,Julia Fehniger,Gina Westhoff,Lauren E. Bollinger
出处
期刊:Journal of Clinical Oncology [American Society of Clinical Oncology]
标识
DOI:10.1200/jco-24-01326
摘要

PURPOSE Lenvatinib plus pembrolizumab (len + pembro) significantly improved progression-free survival (PFS) and overall survival (OS) versus chemotherapy in previously treated advanced or recurrent endometrial cancer (aEC) in the phase III Study 309/KEYNOTE-775. We report results from the phase III, randomized, open-label European Network of Gynaecological Oncological Trial-en9/LEAP-001 study (ClinicalTrials.gov identifier: NCT03884101 ) that evaluated len + pembro versus chemotherapy in first-line aEC. METHODS Patients with stage III to IV or recurrent, radiographically apparent EC and no previous chemotherapy or disease progression ≥6 months after neo/adjuvant platinum-based chemotherapy were randomly assigned 1:1 to lenvatinib 20 mg once daily plus pembrolizumab 200 mg once every 3 weeks or paclitaxel 175 mg/m 2 plus carboplatin AUC 6 mg/mL/min once every 3 weeks. Primary end points were PFS and OS, evaluated in the mismatch repair-proficient (pMMR) and all-comers populations. Noninferiority was assessed for OS at final analysis (FA) for len + pembro versus chemotherapy (multiplicity-adjusted, one-sided nominal alpha, .0159; null hypothesis–tested hazard ratio [HR], 1.1). RESULTS Eight hundred forty-two patients were randomly assigned (len + pembro, n = 420 [pMMR population, n = 320]; chemotherapy, n = 422 [pMMR population, n = 322]). At FA (data cutoff, October 2, 2023), median PFS (95% CI) in the pMMR population was 9.6 (8.2 to 11.9) versus 10.2 (8.4 to 10.5) months with len + pembro versus chemotherapy (hazard ratio [HR], 0.99 [95% CI, 0.82 to 1.21]) and among all-comers was 12.5 (10.3 to 15.1) versus 10.2 (8.4 to 10.4) months (HR, 0.91 [95% CI, 0.76 to 1.09]; descriptive analyses). Median OS (95% CI) in the pMMR population was 30.9 (25.4 to 37.7) versus 29.4 (26.2 to 35.4) months with len + pembro versus chemotherapy (HR, 1.02 [95% CI, 0.83 to 1.26]; noninferiority P = .246, not statistically significant per multiplicity control strategy) and among all-comers was 37.7 (32.2 to 43.6) versus 32.1 (27.2 to 35.7) months (HR, 0.93 [95% CI, 0.77 to 1.12]). Grade ≥3 treatment-related adverse events occurred in 331/420 (79%) versus 274/411 (67%) treated patients. CONCLUSION First-line len + pembro did not meet prespecified statistical criteria for PFS or OS versus chemotherapy in pMMR aEC.
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