FIGHT-302: first-line pemigatinib vs gemcitabine plus cisplatin for advanced cholangiocarcinoma with FGFR2 rearrangements

Author:

Bekaii-Saab Tanios S1ORCID,Valle Juan W2,Van Cutsem Eric3,Rimassa Lorenza45,Furuse Junji6,Ioka Tatsuya7,Melisi Davide8,Macarulla Teresa9,Bridgewater John10,Wasan Harpreet11,Borad Mitesh J1,Abou-Alfa Ghassan K1213,Jiang Ping14,Lihou Christine F14,Zhen Huiling14,Asatiani Ekaterine15,Féliz Luis15,Vogel Arndt16

Affiliation:

1. Division of Hematology/Oncology, Department of Internal Medicine, Mayo Clinic, Phoenix, AZ 85054, USA

2. Division of Cancer Sciences, University of Manchester & Department of Medical Oncology, The Christie Hospital NHS Foundation Trust, The University of Manchester, Manchester, UK

3. Department of Oncology, University of Leuven, Leuven, Belgium

4. Department of Oncology and Hematology, Humanitas Clinical and Research Center-IRCCS, Rozzano, Milan, Italy

5. Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy

6. Department of Medical Oncology, Kyorin University, Tokyo, Japan

7. Department of Cancer Survey and Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan

8. Department of Medicine, University of Verona, Verona, Italy

9. Medical Oncology Department, Vall d'Hebron University Hospital & Vall d'Hebron Institute of Oncology, Barcelona, Spain

10. Research Department of Oncology, UCL Cancer Institute, University College London, London, UK

11. Department of Medical Oncology, Hammersmith Hospital, Imperial College Health Care Trust, London, UK

12. Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA

13. Department of Medicine, Weill Medical College, Cornell University, New York, NY, USA

14. Incyte Corporation, Wilmington, DE, USA

15. Incyte Biosciences International Sàrl, Morges, Switzerland

16. Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany

Abstract

FGFR2 rearrangements resulting in dysregulated signaling are drivers of cholangiocarcinoma (CCA) tumorigenesis, and occur almost exclusively in intrahepatic CCA. Pemigatinib, a selective, potent, oral inhibitor of FGFR1–3, has demonstrated efficacy and safety in a Phase II study of patients with previously treated locally advanced/metastatic CCA harboring FGFR2 fusions/rearrangements. We describe the study design of FIGHT-302, an open-label, randomized, active-controlled, multicenter, global, Phase III study comparing the efficacy and safety of first-line pemigatinib versus gemcitabine plus cisplatin in patients with advanced CCA with FGFR2 rearrangements (NCT03656536). The primary end point is progression-free survival; secondary end points are objective response rate, overall survival, duration of response, disease control rate, safety and quality of life. Clinical Trial Registration: NCT03656536 ( ClinicalTrials.gov )

Publisher

Future Medicine Ltd

Subject

Cancer Research,Oncology,General Medicine

Cited by 119 articles. 订阅此论文施引文献 订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3