Pembrolizumab With or Without Lenvatinib as First-Line Therapy for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Phase III LEAP-010 Study
In participants with PD-L1 CPS ≥1 R/M HNSCC, first-line lenvatinib plus pembrolizumab significantly improved ORR and PFS, but not OS, compared with placebo plus pembrolizumab. The safety profile was consistent with published data.
Authors
- Tomoya Yokota (ORCID: https://orcid.org/0000-0001-7327-7949)
- Daniel Heudobler (ORCID: https://orcid.org/0000-0002-8790-4584)
- Mikhail Klochikhin (ORCID: https://orcid.org/0000-0002-8959-7450)
- Maria Grazia Ghi
- David Zurmeyer
- Achuta Kumar Guddati (ORCID: https://orcid.org/0000-0002-9390-0424)
- Kim Marienhagen
- Bogdan Żurawski
- Victor Oyervides Juarez
- Lara Iglesias Docampo
- Jessica Mason (ORCID: https://orcid.org/0000-0001-6953-2732)
- Chinyere E. Okpara (ORCID: https://orcid.org/0000-0002-5621-9138)
- Sufia Safina (ORCID: https://orcid.org/0000-0002-5309-8406)
- J. Li
- Sadakatsu Ikeda (ORCID: https://orcid.org/0000-0003-1629-7171)
- M. Oliva Bernal
- Upendra P. Hegde (ORCID: https://orcid.org/0000-0001-5732-1401)
- Walter Li Torres
- Nathaniel Bouganim (ORCID: https://orcid.org/0000-0003-0811-876X)
- Jerome H. Goldschmidt
- John F. Deeken (ORCID: https://orcid.org/0000-0001-8414-1553)
- Sebastian Ochsenreither (ORCID: https://orcid.org/0000-0001-6024-4312)
- Daniela Dörfel (ORCID: https://orcid.org/0000-0003-0844-2703)
- Daniel Kuba (ORCID: https://orcid.org/0000-0002-1939-7971)
- Izabella Dębicka
- Matthew Salzberg
- Keon Uk Park (ORCID: https://orcid.org/0000-0002-6902-7063)
- Beatriz Castelo Fernández (ORCID: https://orcid.org/0000-0002-5824-9808)
- Takuma Onoe (ORCID: https://orcid.org/0000-0003-3676-5294)
- Gergely Dombóvári
- Adriana Domingues Valadares
- Asmahane Benmaziane Teillet
- Paul Swiecicki (ORCID: https://orcid.org/0000-0003-2286-3555)
- Hussein Soudy Hussein
- R. Molerón Mancebo
- Thiago Bueno de Oliveira (ORCID: https://orcid.org/0000-0002-6472-3596)
- Yoshitaka Honma (ORCID: https://orcid.org/0000-0002-4209-4493)
- Burak Gümüşçü
- Abirami Sivapiragasam (ORCID: https://orcid.org/0009-0003-5362-591X)
- Tibor Csőszi (ORCID: https://orcid.org/0000-0002-7742-1968)
- Júlia Pastorello (ORCID: https://orcid.org/0000-0003-2326-0617)
- Doru Paul (ORCID: https://orcid.org/0000-0003-4816-9713)
- Robert Alter
- Naoki Nishio (ORCID: https://orcid.org/0009-0001-8026-2080)
- P. Koralewski
- Zhijun Yuan
- Ruey‐Long Hong (ORCID: https://orcid.org/0000-0001-8100-7914)
- Tobias Albrecht (ORCID: https://orcid.org/0000-0001-5564-5621)
- Karine Martins da Trindade (ORCID: https://orcid.org/0009-0006-4947-0304)
- Konrad Klinghammer (ORCID: https://orcid.org/0000-0001-6425-4833)
- Jawad Sheqwara
- Christian Brandts (ORCID: https://orcid.org/0000-0003-1732-2535)
- J. Lambea Sorrosal
- Marco Benasso
- Anna Spreafico (ORCID: https://orcid.org/0000-0002-3034-3042)
- Alberto Bessudo
- Dorota Filarska
- Denis A. Tantsyrev
- Hyun Woo Lee (ORCID: https://orcid.org/0000-0002-6879-9686)
- Yi-Fang Chang
- Guoqing Hu (ORCID: https://orcid.org/0000-0001-6856-7220)
- Mu Yang (ORCID: https://orcid.org/0000-0002-5149-6195)
- Yong Liu (ORCID: https://orcid.org/0000-0001-6697-5052)
- Hakan Harputluoğlu (ORCID: https://orcid.org/0000-0001-8537-5941)
- Torahiko Nakashima (ORCID: https://orcid.org/0000-0002-8109-9174)
- Irene García
- Carlos Hernández Hernández
- Manuel Chaves Conde
- Dency Pilar Milla
- Olivier Dumas
- Patrick Cobb (ORCID: https://orcid.org/0000-0003-0265-5425)
- Marineé Torres
- Muhammet Bekir Hacioğlu
- Martin R. Mueller
- Yungpo Bernard Su
- Muhammed Bulent Akinci
- Meiyu Fang
- Sébastien Salas
- Anna G. Kedrova
- Judit Olah
- Chia-Jui Yen
- Jacek Mackiewicz
- Martina Violati
- Anne Taylor
- Akihito Tsuji
- Antonio Jimeno
- Keun-Wook Lee
- Peter Arkosy
- Yoon Ho Ko
- Kunyu Yang
- Tomasz Rutkowski
- Andrzej Kawecki
- Lisa Licitra
- Erika Hitre
- Steven McCune
- Song Qu
- Kevin Chiu
- Makoto Tahara
- Prakash Neupane
- Kevin J. Harrington
- Luciano Viana
- Michael Boyer
- Vittorio Ferrari
- Saziye Burcak Karaca
- Juan Shen
- Ye Guo
- Franco Nole
- Matthew Griffin
- Gustavo Alves
- Shigenori Kadowaki
- Ning Jia
- Shaoqiang Zhang
- Corina Dutcus
- Feng Jin
- Sercan Aksoy
- Jérome Fayette
- Siddharth Sheth
- Marcio Costa
- Andreas Dietz
- Muh-Hwa Yang
- Jinguan Lin
- Makoto Tahara
- Zhenhua Li
- Mivael Olivera Hurtado de Mendoza
- Hui Wu
- Sercan AKSOY
- Robert Haddad
- Lisa Licitra
- Jameel Muzaffar
- Justine Bruce
- Ye Guo
- Caroline Even
- Douglas Adkins
- Thiago Oliveira
- Florian Clatot
- Shurong Zhang
- Sufang Qiu
- Matthew Taylor
- Shau-Hsuan Li
- Jorge Martinez Rodriguez
- Paul Swiecicki
- Ying Cheng
- Boguslawa Karaszewska
- Shunji Takahashi
- Nobuhiko Oridate
- Ahmet Bilici
- Qingyuan Zhang
- Tsutomu Ueda
- Xiangqian Zheng
- Xiaoming Huang
- Liangfang Shen
- Nianyong Chen
- Ammar Sukari
- Jens Klussmann
- Shunji Takahashi
- Mivael Olivera Hurtado de Mendoza
- Laszlo Landherr
- Carmen Acevedo
- On behalf of the RESOLVE-Lung investigators
- Teresa Guerrero Urbano
- Yan Sun
- Simon Laban
- Robert Metcalf
- Kimberly Benjamin
- Jin Gao
- Sung-Bae Kim
- Rebecca Redman
- Kaoru Tanaka
- Elizabeth Gunderson
- Chaosu Hu
- Sang Hee Cho
- Jose Salinas Paz
- Jerome Fayette
- Xujing Lu
- Robert Lemon
- Paul-Stefan Mauz
- Wenbin Lei
- Guoxin Ren
- Cagatay Arslan
- Robert I. Haddad
- Caroline Even
- Kevin Harrington
- Takashi Kinoshita
Institutions
- Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
- Royal Marsden NHS Foundation Trust (GB)
- University of Milan (IT)
- University of Michigan (US)
- Institut Gustave Roussy (FR)
- Taipei Veterans General Hospital (TW)
- AC Camargo Hospital (BR)
- Zhejiang Cancer Hospital (CN)
- Centre Léon Bérard (FR)
- Hacettepe University Hospital (TR)
- Dana-Farber Cancer Institute (US)
- Instituto Nacional de Enfermedades Neoplásicas (PE)
- Shanghai East Hospital (CN)
- The Cancer Institute Hospital (JP)
- National Cancer Center Hospital East (JP)
- Eisai (United Kingdom) (GB)
- Eisai (United States) (US)
- Fondazione IRCCS Istituto Nazionale dei Tumori (IT)
- Hacettepe University (TR)
Publication Details
- Journal
- Journal of Clinical Oncology
- Published
- 2026-03-12
- DOI
- https://doi.org/10.1200/jco-25-00570
- Primary Topic
- Head and Neck Cancer Studies
- Type
- article
- Field-Weighted Citation Impact
- 0.00