Therapy Detail

Therapy Name Ensartinib
Synonyms
Therapy Description

Ensartinib (X-396) is a small molecule inhibitor of ALK, which inhibits downstream signaling and potentially leads to decreased growth of ALK-expressing tumors (PMID: 21613408).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Ensartinib X-396 ALK Inhibitor 20 Ensartinib (X-396) is a small molecule inhibitor of ALK, which inhibits downstream signaling and potentially leads to decreased growth of ALK-expressing tumors (PMID: 21613408).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
EML4-ALK ALK C1156Y Advanced Solid Tumor sensitive Ensartinib Preclinical Actionable In a preclinical study, Ensartinib (X-396) inhibited growth and Alk phosphorylation in cells expressing the Xalkori (crizotinib) resistance mutation, EML4-ALK C1156Y (PMID: 21613408). 21613408
EML4-ALK Advanced Solid Tumor sensitive Ensartinib Preclinical - Cell culture Actionable In a preclinical study, Ensartinib (X-396) inhibited growth of transformed cells expressing EML4-ALK in culture (PMID: 30002191). 30002191
ALK positive lung non-small cell carcinoma sensitive Ensartinib Phase Ib/II Actionable In a Phase Ib/II trial, Ensartinib (X-396) treatment resulted in partial response (PR) in 60% (19/30) and stable disease in 7% (2/30) of ALK positive non-small cell lung carcinoma patients, PR was 88% (7/8) in crizotinib-naïve patients and 83% (10/12) in patients with prior crizotinib treatment (J Clin Oncol 34, 2016 (suppl; abstr 9056)). detail...
EML4-ALK ALK L1196M Advanced Solid Tumor sensitive Ensartinib Preclinical Actionable In a preclinical study, Ensartinib (X-396) inhibited growth and Alk phosphorylation in cells expressing the Xalkori (crizotinib) resistance mutation, EML4-ALK ALK L1196M (PMID: 21613408). 21613408
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 (PMID: 29563138; NCT01625234). 29563138
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

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Clinical Trial Phase Therapies Title Recruitment Status
NCT03737994 Phase II Cisplatin + Lorlatinib Carboplatin + Lorlatinib Ceritinib Alectinib + Cisplatin Alectinib + Carboplatin Ceritinib + Cisplatin Pemetrexed Carboplatin + Ceritinib Cisplatin + Ensartinib Carboplatin + Ensartinib Brigatinib + Cisplatin Brigatinib Alectinib Brigatinib + Carboplatin Ensartinib Cisplatin + Pemetrexed Crizotinib Carboplatin + Pemetrexed Lorlatinib Biomarker/ALK Inhibitor Combinations in Treating Patients With Stage IV ALK Positive Non-Small Cell Lung Cancer (The NCI-NRG ALK Master Protocol) Recruiting
NCT03420508 Phase II Ensartinib Treating Patients With Melanoma and ALK Alterations With Ensartinib Recruiting
NCT02767804 Phase III Crizotinib Ensartinib eXalt3: Study Comparing X-396 to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients Active, not recruiting
NCT02898116 Phase Ib/II Durvalumab + Ensartinib Ensartinib A Study of ALK Inhibitor, Ensartinib, and Anti-PD-L1, Durvalumab, in Subjects With ALK-rearranged Non-small Cell Lung Cancer Completed
NCT03213652 Phase II Ensartinib Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations (A Pediatric MATCH Treatment Trial) Recruiting
NCT03155620 Phase II Tazemetostat Larotrectinib LY3023414 Vemurafenib Palbociclib Olaparib Ulixertinib Erdafitinib Selumetinib Ensartinib Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial) Recruiting
NCT01625234 Phase Ib/II Ensartinib Phase 1/2 Study of X-396, an Oral ALK Inhibitor, in Patients With Advanced Solid Tumors and Non-Small Cell Lung Cancer Recruiting


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