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Molecular Profile ALK rearrange
Therapy Alectinib
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 rearrange lung non-small cell carcinoma sensitive Alectinib Case Reports/Case Series Actionable In a clinical case study, Alecensa (alectinib) treatment resulted in disease stability in an HIV-positive pregnant patient with non-small cell lung cancer harboring an ALK translocation, with normal fetal development observed (PMID: 36644155). 36644155
ALK rearrange lung non-small cell carcinoma sensitive Alectinib FDA approved - On Companion Diagnostic Actionable In a Phase III trial supporting FDA approval (ALEX), Alecensa (alectinib) treatment resulted in improved rate of progression-free survival compared to Xalkori (crizotinib) (68.4% vs 48.7%, HR=0.47), and median progression-free survival (25.7 vs 10.4 months) in non-small cell lung cancer patients harboring ALK rearrangement (PMID: 28586279; NCT02075840). 28586279 detail... detail...
ALK rearrange lung non-small cell carcinoma sensitive Alectinib Guideline Actionable Alecensa (alectinib) is included in guidelines as preferred first-line therapy and as subsequent therapy for patients with ALK-rearranged advanced or metastatic non-small cell lung cancer (NCCN.org). detail...
ALK rearrange lung non-small cell carcinoma sensitive Alectinib Guideline Actionable Alecensa (alectinib) is included in the Pan-Asian Guidelines Adaptation (PAGA) as first-line therapy for non-small cell lung cancer patients with ALK rearrangements, including patients with CNS involvement, and as subsequent therapy for patients that progress on Xalkori (crizotinib) (PMID: 30596843; ESMO.org). 30596843 detail...
ALK rearrange lung non-small cell carcinoma sensitive Alectinib FDA approved - On Companion Diagnostic Actionable In a Phase III trial supporting FDA approval (ALINA), adjuvant Alecensa (alectinib) treatment improved 2-year disease-free survival rate (93.8% vs 63.0%, HR 0.24, p<0.001) compared to chemotherapy in patients with resected non-small cell lung cancer harboring ALK rearrangement, and was associated with CNS disease-free survival benefit (HR 0.22) (PMID: 38598794; NCT03456076). 38598794 detail... detail...
ALK rearrange lung non-small cell carcinoma sensitive Alectinib Phase II Actionable In a Phase II trial, Alecensa (alectinib) treatment was effective in treating non-small cell lung cancer patients with ALK rearrangement, resulting in a 50% (61/122) objective response rate (ORR) in all patients, a 45% (43/96) ORR in Crizotinib-refractory patients, and an 83% (70/84) CNS disease control rate (PMID: 26598747). 26598747
ALK rearrange lung non-small cell carcinoma sensitive Alectinib Guideline Actionable Alecensa (alectinib) is included in guidelines for patients with metastatic non-small cell lung cancer harboring an ALK rearrangement (PMID: 30285222; ESMO.org). 30285222 detail...
ALK rearrange lung non-small cell carcinoma sensitive Alectinib Clinical Study - Cohort Actionable In a retrospective analysis, non-small cell lung cancer patients with brain metastases harboring an ALK rearrangement demonstrated prolonged survival following treatment with the combination of an ALK-targeted tyrosine kinase inhibitor, including Alecensa (alectinib), and radiotherapy (PMID: 26438117). 26438117
PubMed Id Reference Title Details
(26438117) Extended Survival and Prognostic Factors for Patients With ALK-Rearranged Non-Small-Cell Lung Cancer and Brain Metastasis. Full reference...
(26598747) Alectinib in Crizotinib-Refractory ALK-Rearranged Non-Small-Cell Lung Cancer: A Phase II Global Study. Full reference...
(28586279) Alectinib versus Crizotinib in Untreated ALK-Positive Non-Small-Cell Lung Cancer. Full reference...
NCCN.org Full reference...
(30596843) Pan-Asian adapted Clinical Practice Guidelines for the management of patients with metastatic non-small-cell lung cancer: a CSCO-ESMO initiative endorsed by JSMO, KSMO, MOS, SSO and TOS. Full reference...
ESMO Clinical Practice Guidelines Full reference...
ESMO Clinical Practice Guidelines Full reference...
Full reference...
Full reference...
Alecensa (alectinib) FDA Drug Label Full reference...
Alecensa (alectinib) FDA Drug Label Full reference...
(30285222) Metastatic non-small cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Full reference...
(36644155) A pregnant patient with ALK-positive non-small cell lung cancer treated with alectinib: A case report and review of the literature. Full reference...
(38598794) Alectinib in Resected ALK-Positive Non-Small-Cell Lung Cancer. Full reference...