Department of Pneumology and Respiratory Functional Exploration, University Hospital of Tours, Tours, France.
Department of Medical Oncology, Centre Léon Bérard, Lyon, France.
Lung Cancer. 2024 Oct;196:107934. doi: 10.1016/j.lungcan.2024.107934. Epub 2024 Aug 24.
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.
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).
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.
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.
卡马替尼是一种选择性 MET 抑制剂，在 METex14 突变的非小细胞肺癌（NSCLC）患者的 II 期研究中显示出疗效。然而，卡马替尼的真实世界结果在很大程度上尚不清楚。自 2019 年 6 月起，法国早期准入计划（EAP）为不符合条件或一线标准治疗失败的 METex14 NSCLC 患者提供卡马替尼。
IFCT-2104 CAPMATU 是一项多中心研究，纳入了所有接受 EAP 卡马替尼治疗的 METex14 NSCLC 患者，直至 2021 年 8 月。主要终点为治疗失败时间（TTF）、无进展生存期（PFS）、总生存期（OS）和客观缓解率（ORR）。
共纳入 146 例患者。中位年龄为 74.9 岁，56.6%从未吸烟，32.4%有脑转移。从卡马替尼开始治疗的中位 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 例患者的最佳反应进行了评估，结果显示 ORR 为 55.3%（95%CI 46.8%-63.6%）。治疗初治患者的中位 PFS 为 7.7 个月，而接受过 1 线或 2 线以上治疗的患者分别为 6.0 和 4.1 个月。对于有脑转移的患者，中位 PFS 为 3.0 个月。卡马替尼具有已知的可管理的安全性特征，发生 3 级至 4 级不良事件，主要为外周水肿（8.2%），17.8%的患者发生。
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，具有可管理的安全性特征，甚至在有脑转移和接受多线治疗的患者中也是如此。这项研究强化了卡马替尼在这些患者中的关键作用。
