Efficacy, safety, and biomarker analysis of ensartinib in crizotinib-resistant, ALK-positive non-small-cell lung cancer: a multicentre, phase 2 trial

Publication date: Available online 15 October 2019Source: The Lancet Respiratory MedicineAuthor(s): Yunpeng Yang, Jianya Zhou, Jianying Zhou, Jifeng Feng, Wu Zhuang, Jianhua Chen, Jun Zhao, Wei Zhong, Yanqiu Zhao, Yiping Zhang, Yong Song, Yi Hu, Zhuang Yu, Youling Gong, Yuan Chen, Feng Ye, Shucai Zhang, Lejie Cao, Yun Fan, Gang WuSummaryBackgroundEnsartinib is a potent new-generation ALK inhibitor with high activity against a broad range of known crizotinib-resistant ALK mutations and CNS metastases. We aimed to assess the efficacy and safety of ensartinib in ALK-positive patients with non-small-cell lung cancer (NSCLC), in whom crizotinib therapy was unsuccessful. The associations between ensartinib efficacy and crizotinib-resistant mutations were also explored.MethodsWe did a single-arm, open-label, phase 2 study at 27 centres in China. Patients were aged 18 years or older, had stage IIIb or stage IV ALK-positive NSCLC that had progressed while they were on crizotinib therapy, an Eastern Cooperative Oncology Group performance status of 2 or less, had measurable disease, and had received fewer than three previous treatments. Patients with CNS metastases were included if these metastases were asymptomatic and did not require steroid therapy. All patients received 225 mg ensartinib orally once daily on a continuous dosing schedule. The primary outcome was the proportion of patients with an objective response according to the Response Evaluation Criteria in Solid Tumors (versio...
Source: The Lancet Respiratory Medicine - Category: Respiratory Medicine Source Type: research

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Source: Drugs of Today - Category: Drugs & Pharmacology Tags: Drugs Today (Barc) Source Type: research
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Source: Oncotarget - Category: Cancer & Oncology Tags: Oncotarget Source Type: research
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Source: Memo - Magazine of European Medical Oncology - Category: Cancer & Oncology Source Type: research
Authors: Muniz TP, de Jesus VHF, Sousa VAR, Barbosa MVDR, de Lima VCC Abstract Background: Non-small cell lung cancer (NSCLC) is a major cause of brain metastases. Nonetheless, patients with central nervous system (CNS) spread are poorly represented in clinical trials. We sought to evaluate the overall survival (OS) of patients with NSCLC and CNS metastases. Methods: Patients with NSCLC and CNS metastases treated at A. C. Camargo Cancer Center from January 2007 to December 2017 were selected. The primary endpoint was OS following the diagnosis of CNS metastasis. The Kaplan-Meier method was applied to calculate ...
Source: Journal of Thoracic Disease - Category: Respiratory Medicine Tags: J Thorac Dis Source Type: research
Conclusions: This retrospective analysis of a real-world experience confirms the therapeutic benefit of crizotinib in advanced ALK-positive NSCLC. Our data showed crizotinib is tolerable and effective, comparable with literature report. Occasional serious cardiac toxicity requires attention. PMID: 31656659 [PubMed]
Source: Journal of Thoracic Disease - Category: Respiratory Medicine Tags: J Thorac Dis Source Type: research
Conclusions: Patients with clinical N0-1 NSCLC and synchronous isolated bone metastases may achieve longer survival rates following primary lung tumor resection. PMID: 31656656 [PubMed]
Source: Journal of Thoracic Disease - Category: Respiratory Medicine Tags: J Thorac Dis Source Type: research
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Source: Journal of Neuro-Oncology - Category: Cancer & Oncology Source Type: research
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Source: BMC Cancer - Category: Cancer & Oncology Authors: Tags: Research article Source Type: research
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Source: Journal of Neuro-Oncology - Category: Cancer & Oncology Source Type: research
Conclusions: Crizotinib was effective and well tolerated in Chinese patients with ALK-positive, advanced NSCLC in real-world clinical practice. For patients without BBM, crizotinib as first-line therapy can lead to a longer PFS than second-or later line therapy. CBPD plus local therapy after 1st PD beyond crizotinib is feasible and effective in clinical routine practice.
Source: Frontiers in Oncology - Category: Cancer & Oncology Source Type: research
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