Marion Ferreira , Aurélie Swalduz , Laurent Greillier , Pauline du Rusquec , Hubert Curcio , Judith Raimbourg , Anne-Claire Toffart , Valérie Gounant , Sebastien Couraud , Gonzague De Chabot , Sylvie Friard , José Hureaux , Gaëlle Jeannin , Luc Odier , Charles Ricordel , Marie Wislez , Clotilde Descarpentries , Guillaume Herbreteau , Pascale Missy , Franck Morin , Alexis B. Cortot
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From June 2019, the French Early Access Program (EAP) provided capmatinib to <em>MET</em>ex14 NSCLC patients who were ineligible for or for whom first-line standard therapies had failed.</p></div><div><h3>Methods</h3><p>IFCT-2104 CAPMATU was a multicenter study that included all <em>MET</em>ex14 NSCLC patients who received capmatinib as part of the EAP until August 2021. The primary endpoints were time to treatment failure (TTF), progression-free survival (PFS), overall survival (OS) and objective response rate (ORR).</p></div><div><h3>Results</h3><p>A total of 146 patients were included. The median age was 74.9 years, 56.6 % were never-smokers, and 32.4 % had brain metastases. The median TTF, median PFS and median OS from capmatinib initiation were 5.1 months (95 % CI 4.2–6.0), 4.8 months (95 % CI 4.0–6.0) and 10.4 months (95 % CI 8.3–13.2), respectively. Evaluation of the best response to capmatinib was available for 134 patients and resulted in an ORR of 55.3 % (95 % CI 46.8 %-63.6 %). The median PFS was 7.7 months for treatment-naïve patients and 6.0 and 4.1 months for patients who had received one or 2 + prior lines of treatment, respectively. For patients with brain metastases, the median PFS was 3.0 months. Capmatinib had a known and manageable safety profile, with grade 3 to 4 adverse events, mostly peripheral edema (8.2 %), occurring in 17.8 % of patients.</p></div><div><h3>Conclusion</h3><p>In this large real-world study of <em>MET</em>ex14 NSCLC patients, the efficacy of capmatinib was confirmed, with a manageable safety profile, even in patients with brain metastases and in those who received several lines of treatment. 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Cortot\",\"doi\":\"10.1016/j.lungcan.2024.107934\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>Capmatinib is a selective MET inhibitor with demonstrated efficacy in a phase II study of non-small cell lung cancer (NSCLC) patients harboring <em>MET</em>ex14 mutations. However, the real-world outcomes of capmatinib are largely unknown. From June 2019, the French Early Access Program (EAP) provided capmatinib to <em>MET</em>ex14 NSCLC patients who were ineligible for or for whom first-line standard therapies had failed.</p></div><div><h3>Methods</h3><p>IFCT-2104 CAPMATU was a multicenter study that included all <em>MET</em>ex14 NSCLC patients who received capmatinib as part of the EAP until August 2021. The primary endpoints were time to treatment failure (TTF), progression-free survival (PFS), overall survival (OS) and objective response rate (ORR).</p></div><div><h3>Results</h3><p>A total of 146 patients were included. The median age was 74.9 years, 56.6 % were never-smokers, and 32.4 % had brain metastases. The median TTF, median PFS and median OS from capmatinib initiation were 5.1 months (95 % CI 4.2–6.0), 4.8 months (95 % CI 4.0–6.0) and 10.4 months (95 % CI 8.3–13.2), respectively. Evaluation of the best response to capmatinib was available for 134 patients and resulted in an ORR of 55.3 % (95 % CI 46.8 %-63.6 %). The median PFS was 7.7 months for treatment-naïve patients and 6.0 and 4.1 months for patients who had received one or 2 + prior lines of treatment, respectively. For patients with brain metastases, the median PFS was 3.0 months. 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引用次数: 0
摘要
背景卡马替尼是一种选择性MET抑制剂,在一项针对携带METex14突变的非小细胞肺癌(NSCLC)患者的II期研究中证明了其疗效。然而,卡马替尼在现实世界中的疗效在很大程度上还不得而知。从2019年6月起,法国早期治疗计划(EAP)为不符合条件或一线标准疗法失败的METex14 NSCLC患者提供卡马替尼。方法IFCT-2104 CAPMATU是一项多中心研究,纳入了所有接受卡马替尼治疗的METex14 NSCLC患者,作为EAP的一部分,直到2021年8月。主要终点是治疗失败时间(TTF)、无进展生存期(PFS)、总生存期(OS)和客观反应率(ORR)。中位年龄为74.9岁,56.6%从不吸烟,32.4%有脑转移。卡马替尼起始治疗的中位TTF、中位PFS和中位OS分别为5.1个月(95 % CI 4.2-6.0)、4.8个月(95 % CI 4.0-6.0)和10.4个月(95 % CI 8.3-13.2)。对134名患者的卡马替尼最佳反应进行了评估,结果显示ORR为55.3%(95% CI为46.8%-63.6%)。治疗无效患者的中位生存期为7.7个月,接受过1次或2次以上前线治疗的患者的中位生存期分别为6.0个月和4.1个月。脑转移患者的中位生存期为3.0个月。在这项针对METex14 NSCLC患者的大型真实世界研究中,卡马替尼的疗效得到了证实,即使是脑转移患者和接受过多线治疗的患者,卡马替尼也具有可控的安全性。这项研究加强了卡马替尼在这些患者中的关键作用。
Capmatinib efficacy for METex14 non-small cell lung cancer patients: Results of the IFCT-2104 CAPMATU study
Background
Capmatinib is a selective MET inhibitor with demonstrated efficacy in a phase II study of non-small cell lung cancer (NSCLC) patients harboring METex14 mutations. However, the real-world outcomes of capmatinib are largely unknown. From June 2019, the French Early Access Program (EAP) provided capmatinib to METex14 NSCLC patients who were ineligible for or for whom first-line standard therapies had failed.
Methods
IFCT-2104 CAPMATU was a multicenter study that included all METex14 NSCLC patients who received capmatinib as part of the EAP until August 2021. The primary endpoints were time to treatment failure (TTF), progression-free survival (PFS), overall survival (OS) and objective response rate (ORR).
Results
A total of 146 patients were included. The median age was 74.9 years, 56.6 % were never-smokers, and 32.4 % had brain metastases. The median TTF, median PFS and median OS from capmatinib initiation were 5.1 months (95 % CI 4.2–6.0), 4.8 months (95 % CI 4.0–6.0) and 10.4 months (95 % CI 8.3–13.2), respectively. Evaluation of the best response to capmatinib was available for 134 patients and resulted in an ORR of 55.3 % (95 % CI 46.8 %-63.6 %). The median PFS was 7.7 months for treatment-naïve patients and 6.0 and 4.1 months for patients who had received one or 2 + prior lines of treatment, respectively. For patients with brain metastases, the median PFS was 3.0 months. Capmatinib had a known and manageable safety profile, with grade 3 to 4 adverse events, mostly peripheral edema (8.2 %), occurring in 17.8 % of patients.
Conclusion
In this large real-world study of METex14 NSCLC patients, the efficacy of capmatinib was confirmed, with a manageable safety profile, even in patients with brain metastases and in those who received several lines of treatment. This study reinforces the key role of capmatinib for these patients.
期刊介绍:
Lung Cancer is an international publication covering the clinical, translational and basic science of malignancies of the lung and chest region.Original research articles, early reports, review articles, editorials and correspondence covering the prevention, epidemiology and etiology, basic biology, pathology, clinical assessment, surgery, chemotherapy, radiotherapy, combined treatment modalities, other treatment modalities and outcomes of lung cancer are welcome.