HLX07 alone or combined with serplulimab,cisplatin and 5-fluorouracil for advanced esophageal squamous cell carcinoma:A phase 2 study  

作　　者：Yun Liu Yanfeng Wang Yanrong Zhu Tao Wu Zhenyang Liu Jin Zhou Yuan Yuan Mudan Yang Bo Liu Zhenbo Tan Wu Zhuang Jiayan Chen Ning Li Ying Wang Xuhui Hu Lin Wang Haoyu Yu QingyuWang Jun Zhu Jing Huang 

机构地区：[1]Department of Medical Oncology,National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing,P.R.China [2]Department of Comprehensive Oncology,National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing,P.R.China [3]Department of Internal Medicine,Anyang Tumor Hospital,Anyang,Henan,P.R.China [4]Department of Gastroenterology and Urology,Hunan Cancer Hospital,The Affiliated Cancer Hospital of Xiangya School of Medicine,Central South University,Changsha,Hunan,P.R.China [5]Department of Medical Oncology,Sichuan Cancer Hospital&Institute,Sichuan Cancer Center,Cancer Hospital Affiliated to the School of Medicine,University of Electronic Science and Technology of China,Chengdu,Sichuan,P.R.China [6]Department of Medical Oncology,Xuzhou Central Hospital,Xuzhou,Jiangsu,P.R.China [7]Department of Gastroenterology,Shanxi Cancer Hospital,Taiyuan,Shanxi,P.R.China [8]Department of Medical Oncology,Shandong Cancer Hospital&Institute,Shandong First Medical University and Shandong Academy of Medical Sciences,Jinan,Shandong,P.R.China [9]Department of Thoracic Surgery,Xingtai People’s Hospital,Xingtai,Hebei,P.R.China [10]Department of Medical Oncology,Fujian Cancer Hospital,Fuzhou,Fujian,P.R.China [11]Department of Radiation Oncology,Fudan University Shanghai Cancer Center,Shanghai,P.R.China [12]Department of Medical Oncology,The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital,Zhengzhou,Henan,P.R.China [13]Department of Medical Oncology,Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen Center,Shenzhen,Guangdong,P.R.China [14]Global Product Development,Shanghai Henlius Biotech Inc.,Shanghai,P.R.China

出　　处：《Cancer Communications》2024年第12期1431-1443,共13页癌症通讯(英文)

基　　金：Shanghai Henlius Biotech Inc.

摘　　要：Background:The combination of anti-PD-1 antibody serplulimab and chemotherapy is considered standard first-line therapy for advanced esophageal squamous cell carcinoma(ESCC),but few later-line treatments are available.Here we evaluated the therapeutic efficacy of the recombinant,humanized anti-EGFR antibody HLX07 when used alone or together with serplulimab and chemotherapy against advanced ESCC.Methods:This open-label,non-randomized,two-cohort,phase 2 trial involved patients 18-75 years old with histologically or cytologically confirmed locally advanced,unresectable,or metastatic ESCC,and an Eastern Cooperative Oncology Group performance status of 0-1.Patients who had failed first-line immuno-chemotherapy or at least two lines of other systemic therapy received HLX07 monotherapy intravenously at a dose of 1,000 mg once every 2 weeks(Q2W).Patients with no prior systemic therapy received HLX07(1,000 mg,day 1)and serplulimab(200 mg,day 1)intravenously Q2W for up to 2 years,concurrently with cisplatin(50mg/m^(2),day 1)for up to 8 cycles and 5-fluorouracil(1,200mg/m^(2),days 1-2)for up to 12 cycles intravenously Q2W.The primary endpoints were progression-free survival(PFS)and objective response rate(ORR).Results:Overall,50 patients were enrolled.In the HLX07 monotherapy group,ORR was 15.0%(3/20),and the median PFSwas 1.5 months(95% confidence interval[CI],1.3 to 3.7).The median duration of response was not reached,and the rate of patients showing an objective response lasting at least 6monthswas 66.7%(95%CI,5.4 to 94.5).Two(10.0%,2/20)patients experienced grade 3-4 treatmentrelated adverse events(TRAEs),including hypomagnesemia,hypocalcemia,and fatigue.No patient experienced grade 5 TRAEs.In the HLX07 combination group,the ORR was 60.0%(18/30),and the median PFS was 7.8 months(95%CI,3.3 to 9.1).Fourteen(46.7%,14/30)patients experienced grade 3-4 TRAEs,and one(3.3%,1/30)patient died due to serplulimab-related pneumonitis.Conclusions:HLX07 monotherapy and its combination with serplulimab and chemotherapy showed managea

关 键 词：ANTI-EGFR esophageal squamous cell carcinoma HLX07 phase 2 serplulimab 

分 类 号：R73[医药卫生—肿瘤]