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Gene | ALK |
Variant | positive |
Impact List | unknown |
Protein Effect | unknown |
Gene Variant Descriptions | ALK positive indicates the presence of the ALK gene, mRNA, and/or protein. ALK positive has been used alternatively to refer to presence of an ALK fusion or rearrangement. For related data, refer to ALK fusion or ALK rearrange in CKB. |
Associated Drug Resistance | |
Category Variants Paths |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|
ALK positive | lung non-small cell carcinoma | no benefit | Brigatinib | Phase II | Actionable | In a Phase II trial (ALTA-2), Alunbrig (brigatinib) therapy demonstrated limited efficacy in ALK-positive advanced non-small cell lung cancer patients who previously progressed on Alecensa (alectinib) or Zykadia (ceritinib) therapy, with an objective response rate (ORR) of 26.2% (27/103, 1 complete (CR) and 26 partial responses), duration of response of 6.3 mo, median progression-free survival of 3.8 mo, and intracranial ORR of 15% (8/55, 1 CR) in patients with CNS metastases (PMID: 36096442; NCT05421936). | 36096442 |
ALK positive | lung adenocarcinoma | predicted - sensitive | Alectinib | Case Reports/Case Series | Actionable | In a clinical case study, Alecensa (alectinib) treatment resulted in a partial response in a pregnant patient with ALK-positive metastatic lung adenocarcinoma, with no developmental effects observed during pregnancy or the first 9 months of the infant’s life (PMID: 37087822). | 37087822 |
ALK positive | inflammatory myofibroblastic tumor | predicted - sensitive | Alectinib | Case Reports/Case Series | Actionable | In a clinical case study, Alecensa (alectinib) treatment resulted in partial remission before treatment discontinuation and complete remission following restart of treatment in a 7-year-old pediatric patient with ALK-positive recurrent, metastatic inflammatory myofibroblastic tumor (PMID: 36515740). | 36515740 |
ALK positive | neuroblastoma | predicted - sensitive | Ceritinib | Phase I | Actionable | In a Phase I trial, Zykadia (ceritinib) treatment was well tolerated and resulted in an overall response rate of 20% (6/30; 6 partial response), a disease control rate of 53% (16/30), and a median progression-free survival of 2.4 months in pediatric patients with ALK-positive neuroblastoma (PMID: 34780709; NCT01742286). | 34780709 |
ALK positive | Advanced Solid Tumor | predicted - sensitive | Ceritinib | Phase I | Actionable | In a Phase I trial, Zykadia (ceritinib) treatment was well tolerated and resulted in an overall response rate of 14% (1/7), a disease control rate of 43% (3/7), and a progression-free survival of 1.9 months in pediatric patients with ALK-positive advanced solid tumors other than neuroblastoma, anaplastic large cell lymphoma, or inflammatory myofibroblastic tumor (PMID: 34780709; NCT01742286). | 34780709 |
ALK positive | lung non-small cell carcinoma | sensitive | Ensartinib | Phase II | Actionable | In a Phase II trial, Ensartinib (X-396) treatment resulted in an objective response in 52% (76/147; all partial responses), and disease control in 93% (137/147) of patients with crizotinib-refractory ALK-positive non-small cell lung cancer, and a median progression-free survival of 9.6 mo., and of the 97 patients with brain metastases, 41% (40) demonstrated a partial response, and of those, 28 (70%) had an intracranial response and 39 (98%) had intracranial disease control (PMID: 31628085; NCT03215693). | 31628085 |
ALK positive | neuroblastoma | sensitive | Entrectinib | Case Reports/Case Series | Actionable | In a Phase I trial, Rozlytrek (entrectinib) treatment resulted in partial response in a patient with ALK-positive neuroblastoma (J Clin Oncol 32:5s, 2014 (suppl; abstr 2502)). | detail... |
ALK positive | lung non-small cell carcinoma | sensitive | Entrectinib | Case Reports/Case Series | Actionable | In a Phase I trial, Rozlytrek (entrectinib) treatment resulted in stable disease in a patient with ALK-positive non-small cell lung carcinoma (J Clin Oncol 32:5s, 2014 (suppl; abstr 2502)). | detail... |