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|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||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...|
|ALK positive||lung non-small cell carcinoma||predicted - sensitive||Lorlatinib||Phase III||Actionable||In a Phase III trial, patients with previously untreated ALK-positive advanced non-small cell lung cancer treated with Lorbrena (lorlatinib) demonstrated a significantly improved 12-month progression-free survival rate (78% vs 39%; HR=0.28, p<0.001), objective response rate (76%, 113/149 vs 58%, 85/147; OR=2.25), and intracranial response rate (66%, 25/38 vs 20%, 8/40; OR=8.41) compared to patients treated with Xalkori (crizotinib) (PMID: 33207094; NCT03052608).||33207094|
|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|