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
© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:12 |
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| Enthalten in: |
Journal for immunotherapy of cancer - 12(2024), 2 vom: 21. Feb. |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Ren, Shengxiang [VerfasserIn] |
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| Links: |
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| Themen: |
73096E137E |
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| Anmerkungen: |
Date Completed 26.02.2024 Date Revised 26.02.2024 published: Electronic ClinicalTrials.gov: NCT04346381 Citation Status MEDLINE |
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| doi: |
10.1136/jitc-2023-007227 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM368781577 |
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| 100 | 1 | |a Ren, Shengxiang |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a First-line treatment with camrelizumab plus famitinib in advanced or metastatic NSCLC patients with PD-L1 TPS ≥1% |b results from a multicenter, open-label, phase 2 trial |
| 264 | 1 | |c 2024 | |
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| 500 | |a Date Completed 26.02.2024 | ||
| 500 | |a Date Revised 26.02.2024 | ||
| 500 | |a published: Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT04346381 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. | ||
| 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a TRIAL REGISTRATION NUMBER: NCT04346381 | ||
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Clinical Trial, Phase II | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Drug Therapy, Combination | |
| 650 | 7 | |a camrelizumab |2 NLM | |
| 650 | 7 | |a 73096E137E |2 NLM | |
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| 650 | 7 | |a Antibodies, Monoclonal, Humanized |2 NLM | |
| 700 | 1 | |a Wang, Xicheng |e verfasserin |4 aut | |
| 700 | 1 | |a Han, Bao-Hui |e verfasserin |4 aut | |
| 700 | 1 | |a Pan, Yueyin |e verfasserin |4 aut | |
| 700 | 1 | |a Zhao, Jun |e verfasserin |4 aut | |
| 700 | 1 | |a Cheng, Yufeng |e verfasserin |4 aut | |
| 700 | 1 | |a Hu, Sheng |e verfasserin |4 aut | |
| 700 | 1 | |a Liu, Tianshu |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Yalun |e verfasserin |4 aut | |
| 700 | 1 | |a Cheng, Ying |e verfasserin |4 aut | |
| 700 | 1 | |a Feng, Jifeng |e verfasserin |4 aut | |
| 700 | 1 | |a Yi, Shanyong |e verfasserin |4 aut | |
| 700 | 1 | |a Gu, Shanzhi |e verfasserin |4 aut | |
| 700 | 1 | |a Gao, Shegan |e verfasserin |4 aut | |
| 700 | 1 | |a Luo, Yongzhong |e verfasserin |4 aut | |
| 700 | 1 | |a Liu, Ying |e verfasserin |4 aut | |
| 700 | 1 | |a Liu, Caigang |e verfasserin |4 aut | |
| 700 | 1 | |a Duan, Huijie |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Shuni |e verfasserin |4 aut | |
| 700 | 1 | |a Yang, Xinfeng |e verfasserin |4 aut | |
| 700 | 1 | |a Fan, Jia |e verfasserin |4 aut | |
| 700 | 1 | |a Zhou, Caicun |e verfasserin |4 aut | |
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