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Pucotenlimab in patients with advanced mismatch repair-deficient or microsatellite instability-high solid tumors: A multicenter phase 2 study

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机构: [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 100021, China [2]Department of Oncology, Henan Cancer Hospital, Zhengzhou 450003, China [3]Department of Gastroenterology and Urology, Hunan Cancer Hospital, Changsha 410013, China [4]Department of Medical Oncology, The First Affiliated Hospital of Xi’an Jiaotong University, Xi’an 710061, China [5]Department of Oncology, Tianjin People’s Hospital, Tianjin 300122, China [6]Department of Oncology, Anhui Provincial Cancer Hospital, Hefei 230031, China [7]Department of Medical Oncology, Guangxi Medical University Cancer Hospital, Nanning 530021, China [8]Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450099, China [9]Department of Oncology, Hubei Cancer Hospital, Wuhan 430079, China [10]Department of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China [11]Department of Medical Oncology, The First Hospital of China Medical University, Shenyang 110002, China [12]Department of Medical Oncology, The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou 310009, China [13]Department of Medical Oncology, Shandong Cancer Hospital, Jinan 250117, China [14]Department of Oncology, The Second Affiliated Hospital of Soochow University, Suzhou 215004, China [15]Medical Oncology Department of Gastrointestinal Cancer, Liaoning Cancer Hospital, Shenyang 110801, China [16]Department of Medical Oncology, The First Affiliated Hospital of Xinxiang Medical University, Xinxiang 453003, China [17]Department of Oncology, Peking University Shenzhen Hospital, Shenzhen 516473, China [18]Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai 200032, China [19]Department of Oncology, Xiangya Hospital, Central South University, Changsha 410008, China [20]Department of Gynecologic Oncology, Tianjin Medical University Cancer Institute and Hospital, Tianjin 300060, China [21]Department of Medical Oncology, Zhejiang Cancer Hospital, Hangzhou 310022, China [22]Department of Gastrointestinal Oncology, The Fourth Hospital of Hebei Medical University, Shijiazhuang 050011, China [23]Department of Gastrointestinal Oncology, Harbin Medical University Cancer Hospital, Harbin 150081, China [24]Department of Oncology, Heping Hospital Affiliated to Changzhi Medical College, Changzhi 046000, China [25]Taizhou Hanzhong Biomedical Co., Ltd, Taizhou 225300, China [26]Department of Colorectal Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China
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We report a multicenter, phase 2 study evaluating the efficacy of pucotenlimab, an anti-PD-1 antibody, in patients with mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) tumors, and potential biomarkers for response. Overall, 100 patients with previously treated, advanced solid tumors centrally confirmed as dMMR or MSI-H received pucotenlimab at 200 mg every 3 weeks. The most common cancer type is colorectal cancer (n = 71). With a median follow-up of 22.5 months, the objective response rate is 49.0% (95% confidence interval 38.86%-59.20%) as assessed by the independent review committee, while the median progression-free survival and overall survival have not been reached. Grade ≥3 treatment-related adverse events were observed in 18 patients. For the biomarker analysis, responders are enriched in patients with mutations in the KMT2D gene. Pucotenlimab is an effective treatment option for previously treated advanced dMMR/MSI-H solid tumors, and the predictive value of KMT2D mutation warrants further research. This study is registered with ClinicalTrials.gov: NCT03704246.Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.

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出版当年[2023]版:
大类 | 1 区 医学
小类 | 1 区 医学:研究与实验 2 区 细胞生物学
最新[2025]版:
大类 | 1 区 医学
小类 | 1 区 医学:研究与实验 2 区 细胞生物学
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出版当年[2023]版:
Q1 CELL BIOLOGY Q1 MEDICINE, RESEARCH & EXPERIMENTAL
最新[2024]版:
Q1 CELL BIOLOGY Q1 MEDICINE, RESEARCH & EXPERIMENTAL

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第一作者机构: [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 100021, China
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