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Molecular Profile | ALK rearrange |
Therapy | Ensartinib |
Indication/Tumor Type | lung non-small cell carcinoma |
Response Type | sensitive |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|
ALK rearrange | lung non-small cell carcinoma | sensitive | Ensartinib | Guideline | Actionable | Ensartinib (X-396) is included in guidelines for patients with metastatic non-small cell lung cancer harboring an ALK rearrangement (PMID: 30285222, Version Update 15 Sept 2020; ESMO.org). | detail... 30285222 |
ALK rearrange | lung non-small cell carcinoma | sensitive | Ensartinib | Phase III | Actionable | In a Phase III trial, Ensartinib (X-396) treatment significantly improved progression-free survival in patients with ALK-positive non-small cell lung cancer (25.8 vs 12.7 mo, HR 0.51, p<0.001) compared to Xalkori (crizotinib), and resulted in an intracranial response rate of 63.6% (7 of 11) in patients with target brain metastases at baselinewith compared to 21.1% (4 of 19) with Xalkori (crizotinib) (PMID: 34473194; NCT02767804). | 34473194 |
ALK rearrange | lung non-small cell carcinoma | sensitive | Ensartinib | Clinical Study - Cohort | Actionable | In a retrospective analysis, non-small cell lung cancer patients with brain metastases harboring an ALK rearrangement demonstrated prolonged survival following treatment with the combination of an ALK-targeted tyrosine kinase inhibitor, including Ensartinib (X-396), and radiotherapy (PMID: 26438117). | 26438117 |
ALK rearrange | lung non-small cell carcinoma | sensitive | Ensartinib | Phase Ib/II | Actionable | In a Phase I/II trial, Ensartinib (X-396) treatment resulted in partial response in 60% (36/60) and stable disease in 21.7 % (13/60) of patients with ALK-positive non-small cell lung cancer, with a median progression-free survival of 9.2 months, and a response rate of 80% (12/15) in crizotinib-naïve patients and 69% (20/29) in patients with prior crizotinib treatment (PMID: 29563138; NCT01625234). | 29563138 |
PubMed Id | Reference Title | Details |
---|---|---|
(26438117) | Extended Survival and Prognostic Factors for Patients With ALK-Rearranged Non-Small-Cell Lung Cancer and Brain Metastasis. | Full reference... |
(29563138) | Ensartinib (X-396) in ALK-Positive Non-Small Cell Lung Cancer: Results from a First-in-Human Phase I/II, Multicenter Study. | Full reference... |
ESMO Clinical Practice Guidelines | Full reference... | |
(34473194) | Ensartinib vs Crizotinib for Patients With Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer: A Randomized Clinical Trial. | Full reference... |
(30285222) | Metastatic non-small cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. | Full reference... |