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Sunvozertinib for patients in China with platinum-pretreated locally advanced or metastatic non-small-cell lung cancer and EGFR exon 20 insertion mutation (WU-KONG6): single-arm, open-label, multicentre, phase 2 trial

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作者：
Wang Mengzhao[1] * ; Fan Yun[2] * ; Sun Meili[3] ; Wang Yongsheng[4] ; Zhao Yanqiu[5] ; Jin Bo[6] ; Hu Ying[7] ; Han Zhigang[8] ; Song Xia[9] ; Liu Anwen[10] ; Tang Kejing[11] ; Ding Cuimin[12] ; Liang Li[13] ; Wu Lin[14] ; Gao Junzhen[15] ; Wang Jianghong[16] ; Cheng Ying[17] ; Zhou Jianying[18] ; He Yong[19] ; Dong Xiaorong[20] ; Yao Yu[21] ; Yu Yan[22] ; Wang Huijie[23] ; Sun Si[23] ; Huang Jianan[24] ; Fang Jian[25] ; Li Wen[26] ; Wang Lin[27] ; Ren Xiubao[28] ; Zhou Chengzhi[29] ; Hu Yanping[30] ; Zhao Dahai[31] ; Yang Runxiang[32] ; Xu Fei[33] ; Huang Yijiang[34] ; Pan Yueyin[35] ; Cui Jiuwei[36] ; Xu Yan[37] ; Yang Zhenfan[38] ; Shi Yuankai[39] ;
机构： [1]Peking Union Medical College Hospital, Beijing, China. [2]Zhejiang Cancer Hospital, Hangzhou, China. [3]Jinan Central Hospital, Jinan, China. [4]West China Hospital of Sichuan University, Chengdu, China. [5]Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China. [6]The First Hospital of China Medical University, Shenyang, China. [7]Beijing Chest Hospital, Capital Medical University, Beijing, China. [8]The Affiliated Cancer Hospital of Xinjiang Medical University, Xinjiang, China. [9]Shanxi Provincial Cancer Hospital, Taiyuan, China. [10]The Second Affiliated Hospital of Nanchang University, Nanchang, China. [11]The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China. [12]The Fourth Hospital of Hebei Medical University, Shijiazhuang, China. [13]Peking University Third Hospital, Beijing, China. [14]Hunan Cancer Hospital, Changsha, China. [15]The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, China. [16]Chongqing University Cancer Hospital, Chongqing, China. [17]Jilin Cancer Hospital, Changchun, China. [18]The First Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, China. [19]Army Medical Center of PLA, Chongqing, China. [20]Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, China. [21]The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China. [22]Harbin Medical University Cancer Hospital, Harbin, China. [23]Fudan University Shanghai Cancer Center, Shanghai, China. [24]The First Affiliated Hospital of Soochow University, Suzhou, China. [25]Beijing Cancer Hospital, Beijing, China. [26]The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, China. [27]Hainan General Hospital, Haikou, China. [28]Tianjin Medical University Cancer Institute & Hospital, Tianjin, China. [29]The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China. [30]Hubei Cancer Hospital, Wuhan, China. [31]The Second Hospital of Anhui Medical University, Hefei, China. [32]Yunnan Cancer Hospital, Kunming, China. [33]The First Affiliated Hospital of Nanchang University, Nanchang, China. [34]Hainan Cancer Hospital, Haikou, China. [35]Anhui Provincial Hospital, Hefei, China. [36]The Bethune First Hospital of Jilin University, Changchun, China. [37]Peking Union Medical College Hospital, Beijing, China. [38]Dizal Pharmaceutical, Shanghai, China. [39]Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.
出处：
DOI： 10.1016/S2213-2600(23)00379-X
ISSN：

摘要：
Sunvozertinib is an oral, irreversible, and selective tyrosine kinase inhibitor that has a favourable safety profile and encouraging antitumour activity, as shown in phase 1 studies of patients with heavily pretreated non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutation (exon20ins). We aimed to assess the antitumour efficacy of sunvozertinib in patients with platinum-pretreated locally advanced or metastatic NSCLC with EGFR exon20ins.WU-KONG6 is a single-group, open-label, multicentre phase 2 trial of sunvozertinib monotherapy, conducted across 37 medical centres in China. We enrolled adult patients with pathologically or cytologically confirmed locally advanced or metastatic NSCLC whose tumour tissue carried an EGFR exon20ins mutation. All patients had received at least one line of previous systemic therapy, with at least one line containing platinum-based chemotherapy. The primary endpoint was objective response rate (ORR), as assessed by the independent review committee. The ORR was defined as the percentage of patients who achieved complete or partial response, confirmed by two separate assessments with at least 4-week time interval, until disease progression or initiation of any new anti-cancer therapy. Enrolled patients received sunvozertinib 300 mg once daily until meeting discontinuation criteria per the protocol. Patients who received at least one dose of treatment and were evaluable for efficacy analysis were included in the primary analysis, and all patients who received at least one dose of treatment were included in the safety analysis. This study is registered with ChinaDrugTrials.org, CTR20211009, and ClinicalTrials.gov, NCT05712902, and efficacy and safety follow-up are ongoing.Between July 19, 2021, and May 6, 2022, 104 patients were enrolled. At data cutoff (Oct 17, 2022), the last enrolled patient had been followed up for about 6 months. Among 97 patients evaluable for efficacy analysis, 59 (61%) patients achieved tumour response, with a confirmed ORR of 61% (95% CI 50-71). All tumour responses were partial responses. Tumour responses were observed irrespective of age, sex, smoking history, EGFR exon20ins subtypes, brain metastasis at baseline, previous lines of therapy, and history of onco-immunotherapy. In total, 19 death events occurred over a median follow-up period of 7·6 months (IQR 6·1-9·4). Sunvozertinib was well tolerated at 300 mg once daily. The most common grade 3 or worse treatment-related adverse events were blood creatine phosphokinase increased (18 [17%] of 104), diarrhoea (eight [8%]), and anaemia (six [6%]). The most common serious treatment-related adverse events were interstitial lung disease (five [5%] of 104), anaemia (three [3%]), vomiting (two [2%]), nausea (two [2%]) and pneumonia (two [2%]).In this phase 2 study, sunvozertinib demonstrated antitumour efficacy in patients with platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins, with a manageable safety profile. A multinational randomised, phase 3 study of sunvozertinib versus platinum-doublet chemotherapy in EGFR exon20ins NSCLC is ongoing (NCT05668988).Dizal Pharmaceutical.Copyright © 2023 Elsevier Ltd. All rights reserved.

基金：
Dizal Pharmaceutical.
语种：
外文
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出版当年[2025]版：
大类 | 1 区 医学
小类 | 1 区 危重病医学 1 区 呼吸系统
最新[2025]版：
大类 | 1 区 医学
小类 | 1 区 危重病医学 1 区 呼吸系统
JCR分区：
出版当年[2024]版：
Q1 CRITICAL CARE MEDICINE Q1 RESPIRATORY SYSTEM
最新[2024]版：
Q1 CRITICAL CARE MEDICINE Q1 RESPIRATORY SYSTEM

影响因子： 最新[2024版] 最新五年平均 出版当年[2024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]Peking Union Medical College Hospital, Beijing, China.
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推荐引用方式(GB/T 7714)：
Wang Mengzhao,Fan Yun,Sun Meili,et al.Sunvozertinib for patients in China with platinum-pretreated locally advanced or metastatic non-small-cell lung cancer and EGFR exon 20 insertion mutation (WU-KONG6): single-arm, open-label, multicentre, phase 2 trial[J].LANCET RESPIRATORY MEDICINE.2024,12(3):217-224.doi:10.1016/S2213-2600(23)00379-X.
APA：
Wang Mengzhao,Fan Yun,Sun Meili,Wang Yongsheng,Zhao Yanqiu...&Shi Yuankai.(2024).Sunvozertinib for patients in China with platinum-pretreated locally advanced or metastatic non-small-cell lung cancer and EGFR exon 20 insertion mutation (WU-KONG6): single-arm, open-label, multicentre, phase 2 trial.LANCET RESPIRATORY MEDICINE,12,(3)
MLA：
Wang Mengzhao,et al."Sunvozertinib for patients in China with platinum-pretreated locally advanced or metastatic non-small-cell lung cancer and EGFR exon 20 insertion mutation (WU-KONG6): single-arm, open-label, multicentre, phase 2 trial".LANCET RESPIRATORY MEDICINE 12..3(2024):217-224

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