First-line penpulimab(an anti-PD1 antibody)and anlotinib(an angiogenesis inhibitor)with nab-paclitaxel/gemcitabine(PAAG)in metastatic pancreatic cancer:a prospective,multicentre,biomolecular exploratory,phase II trial  

作　　者：Huizi Sha Fan Tong Jiayao Ni Yi Sun Yahui Zhu Liang Qi Xiaoqin Li Wei Li Yan Yang Qing Gu Xing Zhang Xiaoxuan Wang Chan Zhu Dongsheng Chen Baorui Liu Juan Du 

机构地区：[1]The Comprehensive Cancer Center,Nanjing Drum Tower Hospital,Affiliated Hospital of Medical School,Nanjing University&Clinical Cancer Institute of Nanjing University,Nanjing,China [2]The Comprehensive Cancer Center,Nanjing Drum Tower Hospital,Clinical College of Traditional Chinese and Western Medicine,Nanjing University of Chinese Medicine,Nanjing,China [3]Department of Oncology,The Affiliated Hospital of Jiangsu University,Zhenjiang,China [4]Department of Oncology,The First Affiliated Hospital of Soochow University,Suzhou,China [5]Department of Oncology,The Affiliated Jiangning Hospital of Nanjing Medical University,Nanjing,China [6]National Institute of Healthcare Data Science at Nanjing University,Nanjing,China [7]State Key Laboratory of Neurology and Oncology Drug Development,Jiangsu Simcere Diagnostics Co.,Ltd.,Nanjing Simcere Medical Laboratory Science Co.,Ltd.,Nanjing,China

出　　处：《Signal Transduction and Targeted Therapy》2024年第7期2960-2969,共10页信号转导与靶向治疗（英文）

基　　金：National Key Research and Development Program of China(2020YFA0713804);the National Natural Science Foundation of China(82272811);Jiangsu Province Key Research and Development Program(BE2023654);Nanjing Jiangbei New Area Key Research and Development Program,Special Fund of Health Science and Technology Development of Nanjing(YKK20080);Fundings for Clinical Trials from the Affiliated Drum Tower Hospital,Medical School of Nanjing University(2023-LCYJ-PY-29).

摘　　要：Metastatic pancreatic cancer(mPC)has a dismal prognosis.Herein,we conducted a prospective,multicentre,single-arm,phase II trial evaluating the efficacy and safety of penpulimab and anlotinib in combination with nab-paclitaxel/gemcitabine(PAAG)in patients with first-line mPC(NCT05493995).The primary endpoints included the objective response rate(ORR)and disease control rate(DCR),while secondary endpoints encompassed progression-free survival(PFS),overall survival(OS),and safety.In 66 patients analysed for efficacy,the best response,indicated by the ORR,was recorded at 50.0%(33/66)(95%CI,37.4–62.6%),with 33 patients achieving partial response(PR).Notably,the DCR was 95.5%(63/66,95%CI,87.3–99.1%).The median PFS(mPFS)and OS(mOS)were 8.8(95%CI,8.1–11.6),and 13.7(95%CI,12.4 to not reached)months,respectively.Grade 3/4 treatment-related adverse events(TRAEs)were reported in 39.4%of patients(26/66).In prespecified exploratory analysis,patients with altered SWI/SNF complex had a poorer PFS.Additionally,low serum CA724 level,high T-cell recruitment,low Th17 cell recruitment,and high NK CD56dim cell scores at baseline were potential predicative biomarkers for more favourable efficacy.In conclusion,PAAG as a first-line therapy demonstrated tolerability with promising clinical efficacy for mPC.The biomolecular findings identified in this study possess the potential to guide the precise clinical application of the triple-combo regimen.

关 键 词：CA724 PROSPECTIVE centre 

分 类 号：R735.9[医药卫生—肿瘤]