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A phase II study of efficacy and safety of the MEK inhibitor tunlametinib in patients with advanced NRAS-mutant melanoma

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作者：
Wei Xiaoting[1] * ; Zou Zhengyun[2] * ; Zhang Weizhen[3] * ; Fang Meiyu[4] ; Zhang Xiaoshi[5] ; Luo Zhiguo[6] ; Chen Jing[7] ; Huang Gang[8] ; Zhang Peng[9] ; Cheng Ying[10] ; Liu Jiwei[11] ; Liu Jiyan[12] ; Zhang Junping[13] ; Wu Di[14] ; Chen Yu[15] ; Ma Xiaobiao[16] ; Pan Hongming[17] ; Jiang Renbing[18] ; Liu Xinlan[19] ; Ren Xiubao[20] ; Tian Hongqi[22] ; Jia Zhongwei[21] ; Guo Jun[1] ; Si Lu[1,*1] ;
机构： [1]Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Melanoma and Sarcoma, Peking University Cancer Hospital and [2]Comprehensive Cancer Center (word B7) of Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, Nanjing, China [3]Department of Internal Medicine of Melanoma and Sarcoma, the Third People’s Hospital of Zhengzhou, Henan, China [4]Department of Rare Cancer & Head and Neck Medical Oncology, Cancer Hospital of the University of Chinese Academy of Sciences, Zhejiang Cancer Hospital, [5]State Key Laboratory of Oncology in Southern China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China [6]Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China [7]Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Cancer Centre, Wuhan, China [8]Department of Orthopedics & Soft Tissue, Hunan Cancer Hospital, the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Hunan, [9]Department of Bone and Soft Tissue Cancer, the Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, Henan, China [10]Department of Medical Oncology, Jilin Cancer Hospital, Changchun, China [11]Department of Medical Oncology/the First Affiliated Hospital of Dalian Medical University, Dalian, China [12]Department of Biotherapy, Cancer Center, West China Hospital, Sichuan University, Chengdu, China [13]Department of Thoracic Oncology, Shanxi Bethune Hospital, Taiyuan, China [14]Department of Cancer Center, First Hospital of Jilin University, Changchun, China [15]Department of Medical Oncology, Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital, Fuzhou, China [16]Department of Cancer Biotherapy Center, Yunnan Cancer Hospital, the Third Affiliated Hospital of Kunming Medical University, Yunnan Cancer Hospital, Kunming, [17]Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Medical Oncology, Zhejiang, China [18]Department of Bone and Soft Tissue, the Affiliated Tumor Hospital of Xinjiang Medical University, Xinjiang, China [19]Department of Medical Oncology, General Hospital of Ningxia Medical University, Yinchuan, China [20]Tianjin Medical University Cancer Institute & Hospital, Biotherapy Department, Tianjin, China [21]Department of Clinical Research and Development, Shanghai Kechow Pharma, Inc., Shanghai, China [22]Shanghai Kechow Pharma, Inc., Shanghai, China
出处：
DOI： 10.1016/j.ejca.2024.114008
ISSN：

关键词： Melanoma NRAS mutation MEK inhibitor tunlametinib

摘要：
NRAS-mutant melanoma is an aggressive subtype with poor prognosis; however, there is no approved targeted therapy to date worldwide.We conducted a multicenter, single-arm, phase II, pivotal registrational study that evaluated the efficacy and safety of the MEK inhibitor tunlametinib in patients with unresectable, stage III/IV, NRAS-mutant melanoma (NCT05217303). The primary endpoint was objective response rate (ORR) assessed by independent radiological review committee (IRRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The secondary endpoints included progression-free survival (PFS), disease control rate (DCR), duration of response(DOR), overall survival (OS) and safety.Between November 2, 2020 and February 11, 2022, a total of 100 patients were enrolled. All (n = 100) patients received at least one dose of tunlametinib (safety analysis set [SAS]) and 95 had central laboratory-confirmed NRAS mutations (full analysis set [FAS]). In the FAS, NRAS mutations were observed at Q61 (78.9%), G12 (15.8%) and G13 (5.3%). The IRRC-assessed ORR was 35.8%, with a median DOR of 6.1 months. The median PFS was 4.2 months, DCR was 72.6% and median OS was 13.7 months. Subgroup analysis showed that in patients who had previously received immunotherapy, the ORR was 40.6%. No treatment-related deaths occurred.Tunlametinib showed promising antitumor activity with a manageable safety profile in patients with advanced NRAS-mutant melanoma, including those who had prior exposure to immunotherapy. The findings warrant further validation in a randomized clinical trial.Copyright © 2024. Published by Elsevier Ltd.

基金：
This study was sponsored by Shanghai Kechow Pharma, Inc.
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外文
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大类 | 1 区 医学
小类 | 2 区 肿瘤学
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出版当年[2024]版：
无
最新[2023]版：
Q1 ONCOLOGY

影响因子： 最新[2023版] 最新五年平均 出版当年[2023版] 出版当年五年平均 出版前一年[2023版]

第一作者：
第一作者机构： [1]Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Melanoma and Sarcoma, Peking University Cancer Hospital and
共同第一作者：
通讯作者：
通讯机构： [1]Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Melanoma and Sarcoma, Peking University Cancer Hospital and [*1]Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Melanoma and Sarcoma, Peking University Cancer Hospital and Research Institute, Beijing 100142, China
推荐引用方式(GB/T 7714)：
Wei Xiaoting,Zou Zhengyun,Zhang Weizhen,et al.A phase II study of efficacy and safety of the MEK inhibitor tunlametinib in patients with advanced NRAS-mutant melanoma[J].European Journal Of Cancer (Oxford, England : 1990).2024,202:114008.doi:10.1016/j.ejca.2024.114008.
APA：
Wei Xiaoting,Zou Zhengyun,Zhang Weizhen,Fang Meiyu,Zhang Xiaoshi...&Si Lu.(2024).A phase II study of efficacy and safety of the MEK inhibitor tunlametinib in patients with advanced NRAS-mutant melanoma.European Journal Of Cancer (Oxford, England : 1990),202,
MLA：
Wei Xiaoting,et al."A phase II study of efficacy and safety of the MEK inhibitor tunlametinib in patients with advanced NRAS-mutant melanoma".European Journal Of Cancer (Oxford, England : 1990) 202.(2024):114008

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