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| Molecular Profile | ALK fusion |
| Therapy | Brigatinib |
| Indication/Tumor Type | lung non-small cell carcinoma |
| Response Type | sensitive |
| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| ALK fusion | lung non-small cell carcinoma | sensitive | Brigatinib | Phase Ib/II | Actionable | In a phase I/II clinical trial, Alunbrig (brigatinib) was determined to be safe and efficacious in patients with advanced, ALK-fusion positive NSCLC (PMID: 24091716). | 24091716 |
| ALK fusion | lung non-small cell carcinoma | sensitive | Brigatinib | FDA approved - On Companion Diagnostic | Actionable | In a Phase II trial (ALTA) that supported FDA approval, Alunbrig (brigatinib) treatment resulted in an overall response rate of 45% (51/112) in the 90mg arm and 54% (59/110) in the 180mg arm, and median progression-free survival of 9.2 and 11.0 months respectively, in ALK-rearranged (fusion) non-small cell lung carcinoma patients who progressed on Xalkori (crizotinib) (PMID: 28475456; NCT02094573). | 28475456 detail... |
| ALK fusion | lung non-small cell carcinoma | sensitive | Brigatinib | FDA approved - On Companion Diagnostic | Actionable | In a Phase III trial (ALTA-1L) that supported FDA approval, Alunbrig (brigatinib) treatment resulted in a superior estimated 12-month progression-free survival rate (67% vs 43%, HR=0.49, p=0.0007) compared to Xalkori (crizotinib) in ALK inhibitor-naive patients with ALK-rearrangement positive metastatic non-small cell lung cancer, with a confirmed objective response rate of 71% vs 60%, and confirmed intracranial response rate of 78% vs 29% (PMID: 30280657; NCT02737501). | detail... 30280657 detail... |
| PubMed Id | Reference Title | Details |
|---|---|---|
| (24091716) | Current status of targeted therapy for anaplastic lymphoma kinase-rearranged non-small cell lung cancer. | Full reference... |
| (28475456) | Brigatinib in Patients With Crizotinib-Refractory Anaplastic Lymphoma Kinase-Positive Non-Small-Cell Lung Cancer: A Randomized, Multicenter Phase II Trial. | Full reference... |
| Full reference... | ||
| Alunbrig (brigatinib) FDA Drug Label | Full reference... | |
| Alunbrig (brigatinib) FDA Drug Label | Full reference... | |
| (30280657) | Brigatinib versus Crizotinib in ALK-Positive Non-Small-Cell Lung Cancer. | Full reference... |