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| Molecular Profile | ALK fusion |
| Therapy | Alectinib |
| Indication/Tumor Type | Advanced Solid Tumor |
| Response Type | predicted - sensitive |
| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| ALK fusion | Advanced Solid Tumor | predicted - sensitive | Alectinib | Phase II | Actionable | In a Phase II trial (TACKLE), Alecensa (alectinib) treatment demonstrated activity in adult and pediatric patients with advanced solid tumor harboring ALK fusions or rearrangements (n=17), resulting in an objective response rate (ORR) of 76.5% and disease control rate (DCR) of 82.4%, and median progression-free survival and median overall survival were not reached, and an ORR of 63.6% and DCR of 100% in pediatric patients younger than 15 years (J Clin Oncol 2025 43: 16_suppl, 5612). | detail... |
| ALK fusion | Advanced Solid Tumor | predicted - sensitive | Alectinib | Phase Ib/II | Actionable | In a Phase I/II trial, Alecensa (alectinib) treatment resulted in 1 complete response, 3 partial responses, and 2 stable diseases in 7 evaluable pediatric patients with advanced solid tumors harboring ALK fusions with TPM3, CLTC, PLEKHA7, DCTN1, or HNRNPA3 (Cancer Res (2024) 84 (7_Supplement): CT039; NCT04774718). | detail... |
| PubMed Id | Reference Title | Details |
|---|---|---|
| Abstract CT039: Alectinib in children and adolescents with solid or CNS tumors harboring ALK-fusions: Data from the iMATRIX Alectinib Phase I/II open-label, multi-center study | Full reference... | |
| Efficacy and safety of alectinib in pediatric and adult patients with ALK altered advanced solid tumors: Results from the TACKLE phase II trial, a MASTER KEY substudy (NCCH1712/MK003) | Full reference... |