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 

作者机构：Department of Medical OncologyNational Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences&Peking Union Medical CollegeBeijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted DrugsBeijing 100021China Department I of Thoracic OncologyHunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of MedicineCentral South UniversityChangshaHunan 410083China Department of OncologyThe Affiliated Cancer Hospital of Zhengzhou UniversityZhengzhouHenan 450000China Department II of Head and Neck TumorGansu Provincial Cancer HospitalLanzhouGansu 730050China Department III of RadiotherapyGansu Provincial Cancer HospitalLanzhouGansu 730050China Department I of Thoracic OncologyBeijing Cancer HospitalBeijing 100142China Department of OncologyLinyi People's HospitalLinyiShandong 276002China Department of Respiratory and Critical Care MedicinePeking University People's HospitalBeijing 100032China Department of Medical OncologyPeking Union Medical College HospitalChinese Academy of Medical Sciences&Peking Union Medical CollegeBeijing 100730China Department of Thoracic SurgeryThe Fourth Hospital of Hebei Medical UniversityShijiazhuangHebei 050000China Department of Radiation OncologyShanghai Proton and Heavy Ion CenterFudan University Cancer HospitalShanghai 200030China Department I of OncologyShenyang Chest HospitalShenyangLiaoning 110044China 

出 版 物：《Cancer Pathogenesis and Therapy》 (癌症发生与治疗（英文）)

年 卷 期：2024年第2卷第4期

页      面：268-275页

学科分类：1002[医学-临床医学] 100214[医学-肿瘤学] 10[医学] 

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

主　　题：Anlotinib Penpulimab Small cell lung cancer Efficacy Safety Phase II trial 

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 *** 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 ***: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 *** primary endpoint of the safety run-in phase was *** 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 *** 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 *** 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.