First-line treatment with camrelizumab plus famitinib in advanced or metastatic NSCLC patients with PD-L1 TPS ≥1%: results from a multicenter, open-label, phase 2 trial
机构：[1]Oncology Department, Shanghai Pulmonary Hospital, Shanghai, China[2]Department of Oncology, the First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou, China[3]Department of Respiration, Shanghai Chest Hospital, Shanghai, China[4]Oncology Chemotherapy Department, The First Affiliated Hospital of USTC (Anhui Provincial Hospital), Hefei, China[5]Department of Thoracic Medical Oncology, Beijing Cancer Hospital, Beijing, China[6]Department of Chemotherapy, Qilu Hospital of Shandong University, Jinan, China[7]Department of Thoracic Tumor, Hubei Cancer Hospital, Wuhan, Hubei, China[8]Department of Medical Oncology, Zhongshan Hospital, Fudan University, Shanghai, China[9]Respiratory and Critical Care Medicine, West China School of Medicine/West China Hospital of Sichuan University, Chengdu, China[10]Department of Medical Oncology, Jilin Cancer Hospital, Changchun, Jilin, China[11]Department of Medical Oncology, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, the Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, Jiangsu, China[12]Department of Medical Oncology, Zhengzhou Central Hospital, Zhengzhou, China[13]Department of Interventional Radiology, Hunan Cancer Hospital, Changsha, Hunan, China[14]Department of Medical Oncology, The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, China[15]Thoracic Medicine Department, Hunan Cancer Hospital & the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China[16]Department of Gastroenterology, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China河南省肿瘤医院[17]Department of Oncology, Shengjing Hospital of China Medical University, Shenyang, China中国医科大学附属盛京医院中国医科大学盛京医院[18]Clinical Research & Development, Jiangsu Hengrui Pharmaceuticals Co Ltd, Shanghai, China[19]Department of Liver Surgery and Transplantation, Zhongshan Hospital, Fudan University, Shanghai, China
Background The combination of immune-checkpoint inhibitors and antiangiogenic agents can synergistically modulate the tumor microenvironment and represents a promising treatment option. Here, we evaluated the efficacy and safety of camrelizumab plus famitinib (a receptor tyrosine kinase inhibitor) as a first-line treatment for advanced or metastatic NSCLC patients with a programmed death ligand-1 (PD-L1) tumor proportion score (TPS) of >= 1%, in an open-label, multicenter, phase 2 basket trial.Methods Eligible patients received camrelizumab (200 mg once every 3 weeks via intravenous infusion) plus oral famitinib at an initial dose of 20 mg once daily. The primary endpoint was the objective response rate (ORR), as assessed by the investigator per Response Evaluation Criteria in Solid Tumors V.1.1. Key secondary endpoints included disease control rate (DCR), duration of respons, progression-free survival (PFS), overall survival (OS), 12-month OS rate, and safety profile.Results Of the enrolled 41 patients, 21 (51.2%) had a PD-L1 TPS of 1-49%. As of the cut-off date on June 22, 2022, the combination regimen of camrelizumab and famitinib achieved an ORR of 53.7% (95% CI 37.4% to 69.3%) and a DCR of 92.7% (95% CI 80.1% to 98.5%). The median PFS was 16.6 months (95% CI 8.3 to not reached), and OS data were not yet mature, with an estimated 12-month OS rate of 76.8% (95% CI 60.0% to 87.3%). The most common treatment-related adverse events of grade 3 or higher included hypertension (22.0%), increased alanine aminotransferase (12.2%), decreased neutrophil count (9.8%), proteinuria (7.3%), decrease platelet count (7.3%), and hypokalemia (7.3%). One (2.4%) patient died from grade 5 hemoptysis, which was considered possibly related to the study treatment by the investigator.Conclusion Camrelizumab plus famitinib demonstrated promising antitumor activity in advanced or metastatic NSCLC patients and had an acceptable safety profile. These findings suggest that this combination regimen could be an alternative therapeutic option and warrant further investigation.Trial registration number NCT04346381.
基金：
Science and Technology Commission of Shanghai Municipality [21XD1423200]; National Key Clinical Program on thoracic oncology(2023)
第一作者机构：[1]Oncology Department, Shanghai Pulmonary Hospital, Shanghai, China
通讯作者：
推荐引用方式(GB/T 7714)：
Ren Shengxiang,Wang Xicheng,Han Bao-Hui,et al.First-line treatment with camrelizumab plus famitinib in advanced or metastatic NSCLC patients with PD-L1 TPS ≥1%: results from a multicenter, open-label, phase 2 trial[J].JOURNAL FOR IMMUNOTHERAPY OF CANCER.2024,12(2):doi:10.1136/jitc-2023-007227.
APA：
Ren, Shengxiang,Wang, Xicheng,Han, Bao-Hui,Pan, Yueyin,Zhao, Jun...&Zhou, Caicun.(2024).First-line treatment with camrelizumab plus famitinib in advanced or metastatic NSCLC patients with PD-L1 TPS ≥1%: results from a multicenter, open-label, phase 2 trial.JOURNAL FOR IMMUNOTHERAPY OF CANCER,12,(2)
MLA：
Ren, Shengxiang,et al."First-line treatment with camrelizumab plus famitinib in advanced or metastatic NSCLC patients with PD-L1 TPS ≥1%: results from a multicenter, open-label, phase 2 trial".JOURNAL FOR IMMUNOTHERAPY OF CANCER 12..2(2024)
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