Therapy Detail

Therapy Name Ensartinib
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).

Filtering

  • Case insensitive filtering will display rows where any text in any cell matches the filter term
  • Simple literal full or partial string matches
  • Separate multiple filter terms with a spaces, order doesn't matter (a b c and c b a are equivalent )
  • Filtering will only apply to rows that are already loaded on the page, filtering has no impact on query parameters
  • Use quotes to match a longer phrase which contains spaces "mtor c1483f"

Sorting

  • Generally, the default sort order for tables is set to be first column ascending, however, specific tables may set a different default sort order.
  • Click on any column header arrows to sort by that column
  • Hold down the Shift key and click multiple columns to sort by more than one column, be sure to set ascending or descending order for a given column, before moving on to the next column.

Drug Name Trade Name Synonyms Drug Classes Drug Description
Ensartinib X-396 ALK Inhibitor 19 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).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
ALK rearrange non-small cell lung 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 non-small cell lung carcinoma sensitive Ensartinib Clinical Study Actionable In a retrospective study, 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
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 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 positive non-small cell lung 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 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
Clinical Trial Phase Therapies Title Recruitment Status
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
NCT03420508 Phase II Ensartinib Treating Patients With Melanoma and ALK Alterations With Ensartinib Recruiting
NCT02898116 Phase Ib/II MEDI4736 + X-396 Ensartinib A Study of ALK Inhibitor, Ensartinib, and Anti-PD-L1, Durvalumab, in Subjects With ALK-rearranged Non-small Cell Lung Cancer Completed
NCT03155620 Phase II Tazemetostat Larotrectinib LY3023414 Vemurafenib Olaparib Selumetinib Ensartinib Pediatric MATCH: Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Advanced Refractory Solid Tumors or Lymphomas Recruiting
NCT03213652 Phase II Ensartinib Pediatric MATCH: Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations 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