Efficacy and safety of anlotinib plus penpulimab as second-line treatment for small cell lung cancer:A multicenter,open-label,single-arm phase Ⅱ trial  

作　　者：Changgong Zhang Jianhua Chen Huijuan Wu Jun Wang Liying Gao Jun Zhao Yan Sun Zhongyao Jia Xinlin Mu Chunmei Bai Rui Wang Kailiang Wu Qiang Liu Yuankai Shi 

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&Peking Union Medical College,Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs,Beijing 100021,China [2]Department I of Thoracic Oncology,Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine,Central South University,Changsha,Hunan 410083,China [3]Department of Oncology,The Affiliated Cancer Hospital of Zhengzhou University,Zhengzhou,Henan 450000,China [4]Department II of Head and Neck Tumor,Gansu Provincial Cancer Hospital,Lanzhou,Gansu 730050,China [5]Department III of Radiotherapy,Gansu Provincial Cancer Hospital,Lanzhou,Gansu 730050,China [6]Department I of Thoracic Oncology,Beijing Cancer Hospital,Beijing 100142,China [7]Department of Oncology,Linyi People's Hospital,Linyi,Shandong 276002,China [8]Department of Respiratory and Critical Care Medicine,Peking University People's Hospital,Beijing 100032,China [9]Department of Medical Oncology,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences&Peking Union Medical College,Beijing 100730,China [10]Department of Thoracic Surgery,The Fourth Hospital of Hebei Medical University,Shijiazhuang,Hebei 050000,China [11]Department of Radiation Oncology,Shanghai Proton and Heavy Ion Center,Fudan University Cancer Hospital,Shanghai 200030,China [12]Department I of Oncology,Shenyang Chest Hospital,Shenyang,Liaoning 110044,China

出　　处：《Cancer Pathogenesis and Therapy》2024年第4期268-275,共8页癌症发生与治疗（英文）

基　　金：supported by the National Science and Technology Major Project for Key New Drug Development(No.2017ZX09304015).

摘　　要：Background:Currently,the need for new therapeutic strategies involving programmed cell death protein-1(PD-1)monoclonal antibodies in the second-line setting of small cell lung cancer(SCLC)is urgent.This study aimed to evaluate the efficacy and safety of anlotinib plus penpulimab as a second-line treatment for patients with SCLC who progressed after first-line platinum-based chemotherapy.Methods:This study included the patients from Cohort 4 of a single-arm,open-label,multicenter,phase II clinical trial.A safety run-in phase was performed under anlotinib(10/12 mg quaque die[QD],days 1–14)plus penpulimab(200 mg intravenously[IV],day 1)in a 21-day cycle,followed by the formal trial in which the patients received anlotinib(12 mg QD,days 1–14)plus penpulimab(200 mg IV,day 1)in a 21-day cycle.The primary endpoint of the safety run-in phase was safety.The primary endpoint of the formal trial phase was the objective response rate(ORR).Results:From April 28,2020,to November 24,2020,21 patients were enrolled from 11 hospitals,including 2 in the safety run-in phase and 19 in the formal trial phase.In the formal trial phase,the ORR was 42.1%(8/19;95%confidence interval[CI]:17.7–66.6%).The median progression-free survival was 4.8 months(95%CI:2.9–11.3 months),and the median overall survival was 13.0 months(95%CI:4.6–not applicable[NA]months).The incidence of grade 3 treatment-related adverse events(TRAEs)was 52.4%(11/21),and the incidence of treatment-related serious adverse events(AEs)was 28.6%(6/21).Two AE-related deaths occurred.The most common AEs were hypertension(57.1%,12/21),hypothyroidism(42.9%,9/21),and hypertriglyceridemia(38.1%,8/21).Conclusions:In patients with SCLC who progressed after first-line platinum-based chemotherapy,the second-line anlotinib plus penpulimab treatment demonstrates promising anti-cancer activity and a manageable safety profile,which warrants further investigation.

关 键 词：Anlotinib Penpulimab Small cell lung cancer EFFICACY Safety PhaseⅡtrial 

分 类 号：R734.2[医药卫生—肿瘤]