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Molecular Profile ALK fusion
Therapy Brigatinib
Indication/Tumor Type lung non-small cell carcinoma
Response Type sensitive

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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...