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
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) a...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
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BMJ Publishing Group
2024-02-01
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| Series: | Journal for ImmunoTherapy of Cancer |
| Online Access: | https://jitc.bmj.com/content/12/2/e007227.full |
| _version_ | 1797289631467700224 |
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| author | Ying Liu Jia Fan Jun Zhao Tianshu Liu Caicun Zhou Shengxiang Ren Ying Cheng Caigang Liu Xicheng Wang Sheng Hu Yufeng Cheng Yueyin Pan Shegan Gao Yalun Li Bao-Hui Han Jifeng Feng Shanyong Yi Shanzhi Gu Yongzhong Luo Huijie Duan Shuni Wang Xinfeng Yang |
| author_facet | Ying Liu Jia Fan Jun Zhao Tianshu Liu Caicun Zhou Shengxiang Ren Ying Cheng Caigang Liu Xicheng Wang Sheng Hu Yufeng Cheng Yueyin Pan Shegan Gao Yalun Li Bao-Hui Han Jifeng Feng Shanyong Yi Shanzhi Gu Yongzhong Luo Huijie Duan Shuni Wang Xinfeng Yang |
| author_sort | Ying Liu |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-07T19:07:54Z |
| format | Article |
| id | doaj.art-e64460bcef6e43cab39d61f9e42164e6 |
| institution | Directory Open Access Journal |
| issn | 2051-1426 |
| language | English |
| last_indexed | 2024-03-07T19:07:54Z |
| publishDate | 2024-02-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | Journal for ImmunoTherapy of Cancer |
| spelling | doaj.art-e64460bcef6e43cab39d61f9e42164e62024-03-01T07:45:09ZengBMJ Publishing GroupJournal for ImmunoTherapy of Cancer2051-14262024-02-0112210.1136/jitc-2023-007227First-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 trialYing Liu0Jia Fan1Jun Zhao2Tianshu Liu3Caicun Zhou4Shengxiang Ren5Ying Cheng6Caigang Liu7Xicheng Wang8Sheng Hu9Yufeng Cheng10Yueyin Pan11Shegan Gao12Yalun Li13Bao-Hui Han14Jifeng Feng15Shanyong Yi16Shanzhi Gu17Yongzhong Luo18Huijie Duan19Shuni Wang20Xinfeng Yang21Department of Gastroenterology, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, ChinaDepartment of Liver Surgery and Transplantation, Zhongshan Hospital, Fudan University, Shanghai, ChinaDepartment of Thoracic Medical Oncology, Beijing Cancer Hospital, Beijing, ChinaDepartment of Medical Oncology, Zhongshan Hospital, Fudan University, Shanghai, ChinaOncology Department, Shanghai Pulmonary Hospital, Shanghai, ChinaOncology Department, Shanghai Pulmonary Hospital, Shanghai, ChinaDepartment of Medical Oncology, Jilin Cancer Hospital, Changchun, Jilin, ChinaDepartment of Oncology, Shengjing Hospital of China Medical University, Shenyang, ChinaDepartment of Oncology, the First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou, ChinaDepartment of Thoracic Tumor, Hubei Cancer Hospital, Wuhan, Hubei, ChinaDepartment of Chemotherapy, Qilu Hospital of Shandong University, Jinan, ChinaOncology Chemotherapy Department, The First Affiliated Hospital of USTC (Anhui Provincial Hospital), Hefei, ChinaDepartment of Medical Oncology, The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, ChinaRespiratory and Critical Care Medicine, West China School of Medicine/West China Hospital of Sichuan University, Chengdu, ChinaDepartment of Respiration, Shanghai Chest Hospital, Shanghai, ChinaDepartment of Medical Oncology, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, the Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, Jiangsu, ChinaDepartment of Medical Oncology, Zhengzhou Central Hospital, Zhengzhou, ChinaDepartment of Interventional Radiology, Hunan Cancer Hospital, Changsha, Hunan, ChinaThoracic Medicine Department, Hunan Cancer Hospital & the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, ChinaClinical Research & Development, Jiangsu Hengrui Pharmaceuticals Co Ltd, Shanghai, ChinaClinical Research & Development, Jiangsu Hengrui Pharmaceuticals Co Ltd, Shanghai, ChinaClinical Research & Development, Jiangsu Hengrui Pharmaceuticals Co Ltd, Shanghai, ChinaBackground 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.https://jitc.bmj.com/content/12/2/e007227.full |
| spellingShingle | Ying Liu Jia Fan Jun Zhao Tianshu Liu Caicun Zhou Shengxiang Ren Ying Cheng Caigang Liu Xicheng Wang Sheng Hu Yufeng Cheng Yueyin Pan Shegan Gao Yalun Li Bao-Hui Han Jifeng Feng Shanyong Yi Shanzhi Gu Yongzhong Luo Huijie Duan Shuni Wang Xinfeng Yang 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 |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://jitc.bmj.com/content/12/2/e007227.full |
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