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...
Ausführliche Beschreibung
Autor*in: |
Ying Liu [verfasserIn] Jia Fan [verfasserIn] Jun Zhao [verfasserIn] Tianshu Liu [verfasserIn] Caicun Zhou [verfasserIn] Shengxiang Ren [verfasserIn] Ying Cheng [verfasserIn] Caigang Liu [verfasserIn] Xicheng Wang [verfasserIn] Sheng Hu [verfasserIn] Yufeng Cheng [verfasserIn] Yueyin Pan [verfasserIn] Shegan Gao [verfasserIn] Yalun Li [verfasserIn] Bao-Hui Han [verfasserIn] Jifeng Feng [verfasserIn] Shanyong Yi [verfasserIn] Shanzhi Gu [verfasserIn] Yongzhong Luo [verfasserIn] Huijie Duan [verfasserIn] Shuni Wang [verfasserIn] Xinfeng Yang [verfasserIn] |
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E-Artikel |
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Sprache: |
Englisch |
Erschienen: |
2024 |
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Übergeordnetes Werk: |
In: Journal for ImmunoTherapy of Cancer - BMJ Publishing Group, 2013, 12(2024), 2 |
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Übergeordnetes Werk: |
volume:12 ; year:2024 ; number:2 |
Links: |
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DOI / URN: |
10.1136/jitc-2023-007227 |
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Katalog-ID: |
DOAJ10034447X |
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520 | |a 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. | ||
653 | 0 | |a Neoplasms. Tumors. Oncology. Including cancer and carcinogens | |
700 | 0 | |a Jia Fan |e verfasserin |4 aut | |
700 | 0 | |a Jun Zhao |e verfasserin |4 aut | |
700 | 0 | |a Tianshu Liu |e verfasserin |4 aut | |
700 | 0 | |a Caicun Zhou |e verfasserin |4 aut | |
700 | 0 | |a Shengxiang Ren |e verfasserin |4 aut | |
700 | 0 | |a Ying Cheng |e verfasserin |4 aut | |
700 | 0 | |a Caigang Liu |e verfasserin |4 aut | |
700 | 0 | |a Xicheng Wang |e verfasserin |4 aut | |
700 | 0 | |a Sheng Hu |e verfasserin |4 aut | |
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700 | 0 | |a Huijie Duan |e verfasserin |4 aut | |
700 | 0 | |a Shuni Wang |e verfasserin |4 aut | |
700 | 0 | |a Xinfeng Yang |e verfasserin |4 aut | |
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10.1136/jitc-2023-007227 doi (DE-627)DOAJ10034447X (DE-599)DOAJe64460bcef6e43cab39d61f9e42164e6 DE-627 ger DE-627 rakwb eng RC254-282 Ying Liu verfasserin aut 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 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. Neoplasms. Tumors. Oncology. Including cancer and carcinogens Jia Fan verfasserin aut Jun Zhao verfasserin aut Tianshu Liu verfasserin aut Caicun Zhou verfasserin aut Shengxiang Ren verfasserin aut Ying Cheng verfasserin aut Caigang Liu verfasserin aut Xicheng Wang verfasserin aut Sheng Hu verfasserin aut Yufeng Cheng verfasserin aut Yueyin Pan verfasserin aut Shegan Gao verfasserin aut Yalun Li verfasserin aut Bao-Hui Han verfasserin aut Jifeng Feng verfasserin aut Shanyong Yi verfasserin aut Shanzhi Gu verfasserin aut Yongzhong Luo verfasserin aut Huijie Duan verfasserin aut Shuni Wang verfasserin aut Xinfeng Yang verfasserin aut In Journal for ImmunoTherapy of Cancer BMJ Publishing Group, 2013 12(2024), 2 (DE-627)750086335 (DE-600)2719863-7 20511426 nnns volume:12 year:2024 number:2 https://doi.org/10.1136/jitc-2023-007227 kostenfrei https://doaj.org/article/e64460bcef6e43cab39d61f9e42164e6 kostenfrei https://jitc.bmj.com/content/12/2/e007227.full kostenfrei https://doaj.org/toc/2051-1426 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 12 2024 2 |
spelling |
10.1136/jitc-2023-007227 doi (DE-627)DOAJ10034447X (DE-599)DOAJe64460bcef6e43cab39d61f9e42164e6 DE-627 ger DE-627 rakwb eng RC254-282 Ying Liu verfasserin aut 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 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. Neoplasms. Tumors. Oncology. Including cancer and carcinogens Jia Fan verfasserin aut Jun Zhao verfasserin aut Tianshu Liu verfasserin aut Caicun Zhou verfasserin aut Shengxiang Ren verfasserin aut Ying Cheng verfasserin aut Caigang Liu verfasserin aut Xicheng Wang verfasserin aut Sheng Hu verfasserin aut Yufeng Cheng verfasserin aut Yueyin Pan verfasserin aut Shegan Gao verfasserin aut Yalun Li verfasserin aut Bao-Hui Han verfasserin aut Jifeng Feng verfasserin aut Shanyong Yi verfasserin aut Shanzhi Gu verfasserin aut Yongzhong Luo verfasserin aut Huijie Duan verfasserin aut Shuni Wang verfasserin aut Xinfeng Yang verfasserin aut In Journal for ImmunoTherapy of Cancer BMJ Publishing Group, 2013 12(2024), 2 (DE-627)750086335 (DE-600)2719863-7 20511426 nnns volume:12 year:2024 number:2 https://doi.org/10.1136/jitc-2023-007227 kostenfrei https://doaj.org/article/e64460bcef6e43cab39d61f9e42164e6 kostenfrei https://jitc.bmj.com/content/12/2/e007227.full kostenfrei https://doaj.org/toc/2051-1426 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 12 2024 2 |
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10.1136/jitc-2023-007227 doi (DE-627)DOAJ10034447X (DE-599)DOAJe64460bcef6e43cab39d61f9e42164e6 DE-627 ger DE-627 rakwb eng RC254-282 Ying Liu verfasserin aut 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 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. Neoplasms. Tumors. Oncology. Including cancer and carcinogens Jia Fan verfasserin aut Jun Zhao verfasserin aut Tianshu Liu verfasserin aut Caicun Zhou verfasserin aut Shengxiang Ren verfasserin aut Ying Cheng verfasserin aut Caigang Liu verfasserin aut Xicheng Wang verfasserin aut Sheng Hu verfasserin aut Yufeng Cheng verfasserin aut Yueyin Pan verfasserin aut Shegan Gao verfasserin aut Yalun Li verfasserin aut Bao-Hui Han verfasserin aut Jifeng Feng verfasserin aut Shanyong Yi verfasserin aut Shanzhi Gu verfasserin aut Yongzhong Luo verfasserin aut Huijie Duan verfasserin aut Shuni Wang verfasserin aut Xinfeng Yang verfasserin aut In Journal for ImmunoTherapy of Cancer BMJ Publishing Group, 2013 12(2024), 2 (DE-627)750086335 (DE-600)2719863-7 20511426 nnns volume:12 year:2024 number:2 https://doi.org/10.1136/jitc-2023-007227 kostenfrei https://doaj.org/article/e64460bcef6e43cab39d61f9e42164e6 kostenfrei https://jitc.bmj.com/content/12/2/e007227.full kostenfrei https://doaj.org/toc/2051-1426 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 12 2024 2 |
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10.1136/jitc-2023-007227 doi (DE-627)DOAJ10034447X (DE-599)DOAJe64460bcef6e43cab39d61f9e42164e6 DE-627 ger DE-627 rakwb eng RC254-282 Ying Liu verfasserin aut 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 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. Neoplasms. Tumors. Oncology. Including cancer and carcinogens Jia Fan verfasserin aut Jun Zhao verfasserin aut Tianshu Liu verfasserin aut Caicun Zhou verfasserin aut Shengxiang Ren verfasserin aut Ying Cheng verfasserin aut Caigang Liu verfasserin aut Xicheng Wang verfasserin aut Sheng Hu verfasserin aut Yufeng Cheng verfasserin aut Yueyin Pan verfasserin aut Shegan Gao verfasserin aut Yalun Li verfasserin aut Bao-Hui Han verfasserin aut Jifeng Feng verfasserin aut Shanyong Yi verfasserin aut Shanzhi Gu verfasserin aut Yongzhong Luo verfasserin aut Huijie Duan verfasserin aut Shuni Wang verfasserin aut Xinfeng Yang verfasserin aut In Journal for ImmunoTherapy of Cancer BMJ Publishing Group, 2013 12(2024), 2 (DE-627)750086335 (DE-600)2719863-7 20511426 nnns volume:12 year:2024 number:2 https://doi.org/10.1136/jitc-2023-007227 kostenfrei https://doaj.org/article/e64460bcef6e43cab39d61f9e42164e6 kostenfrei https://jitc.bmj.com/content/12/2/e007227.full kostenfrei https://doaj.org/toc/2051-1426 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 12 2024 2 |
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10.1136/jitc-2023-007227 doi (DE-627)DOAJ10034447X (DE-599)DOAJe64460bcef6e43cab39d61f9e42164e6 DE-627 ger DE-627 rakwb eng RC254-282 Ying Liu verfasserin aut 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 2024 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. Neoplasms. Tumors. Oncology. Including cancer and carcinogens Jia Fan verfasserin aut Jun Zhao verfasserin aut Tianshu Liu verfasserin aut Caicun Zhou verfasserin aut Shengxiang Ren verfasserin aut Ying Cheng verfasserin aut Caigang Liu verfasserin aut Xicheng Wang verfasserin aut Sheng Hu verfasserin aut Yufeng Cheng verfasserin aut Yueyin Pan verfasserin aut Shegan Gao verfasserin aut Yalun Li verfasserin aut Bao-Hui Han verfasserin aut Jifeng Feng verfasserin aut Shanyong Yi verfasserin aut Shanzhi Gu verfasserin aut Yongzhong Luo verfasserin aut Huijie Duan verfasserin aut Shuni Wang verfasserin aut Xinfeng Yang verfasserin aut In Journal for ImmunoTherapy of Cancer BMJ Publishing Group, 2013 12(2024), 2 (DE-627)750086335 (DE-600)2719863-7 20511426 nnns volume:12 year:2024 number:2 https://doi.org/10.1136/jitc-2023-007227 kostenfrei https://doaj.org/article/e64460bcef6e43cab39d61f9e42164e6 kostenfrei https://jitc.bmj.com/content/12/2/e007227.full kostenfrei https://doaj.org/toc/2051-1426 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 12 2024 2 |
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Ying Liu @@aut@@ Jia Fan @@aut@@ Jun Zhao @@aut@@ Tianshu Liu @@aut@@ Caicun Zhou @@aut@@ Shengxiang Ren @@aut@@ Ying Cheng @@aut@@ Caigang Liu @@aut@@ Xicheng Wang @@aut@@ Sheng Hu @@aut@@ Yufeng Cheng @@aut@@ Yueyin Pan @@aut@@ Shegan Gao @@aut@@ Yalun Li @@aut@@ Bao-Hui Han @@aut@@ Jifeng Feng @@aut@@ Shanyong Yi @@aut@@ Shanzhi Gu @@aut@@ Yongzhong Luo @@aut@@ Huijie Duan @@aut@@ Shuni Wang @@aut@@ Xinfeng Yang @@aut@@ |
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Ying Liu misc RC254-282 misc Neoplasms. Tumors. Oncology. Including cancer and carcinogens 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 |
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RC254-282 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 |
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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 |
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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 |
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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 |
abstract |
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. |
abstractGer |
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. |
abstract_unstemmed |
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. |
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