Profile
General Information
Alecensa (alectinib) is a kinase inhibitor that targets ALK and RET.
Alecensa is specifically indicated for:
- adjuvant treatment in adult patients following tumor resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors ≥ 4 cm or node positive) as detected by an FDA approved test.
- the treatment of adult patients with ALK-positive metastatic NSCLC as detected by an FDA approved test
Alecensa is supplied as a capsule for oral administration. The recommended dose is 600 mg orally twice daily, taken with food. Administer until disease progression or unacceptable toxicity. Please see drug label for specific dose modifications.
Mechanism of Action
Alecensa (alectinib) is a kinase inhibitor that targets ALK and RET. In nonclinical studies, alectinib inhibited ALK phosphorylation and ALK-mediated activation of the downstream signaling proteins STAT3 and AKT, and decreased tumor cell viability in multiple cell lines harboring ALK fusions, amplifications, or activating mutations. The major active metabolite of alectinib, M4, showed similar in vitro potency and activity.
Side Effects
Adverse effects associated with the use of Alecensa may include, but are not limited to, the following:
- hepatotoxicity
- constipation
- fatigue
- myalgia
- edema
- rash
- cough
Clinical Trial Results
Approval was based on the results of two single-arm clinical trials of patients with metastatic ALK-positive NSCLC whose disease was no longer controlled by treatment with Xalkori. Subjects received Alecensa twice daily to measure the drug’s effect on their lung cancer tumors. In the first study, 38 percent of subjects experienced a partial shrinkage of their NSCLC tumors, an effect that lasted for an average of 7.5 months. In the second study, 44 percent of subjects experienced a partial shrinkage of their NSCLC tumors, lasting for an average of 11.2 months. The trials also examined Alecensa’s effect on brain metastases, a common occurrence in this population. Sixty-one percent of subjects in the two trials who had measurable brain metastases experienced a complete or partial reduction in their brain tumors, lasting an average of 9.1 months.
The FDA approval of Alecensa for adjuvant treatment following tumor resection for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors ≥ 4 cm or node positive) was based on positive results from the Phase III ALINA study that demonstrated Alecensa reduced the risk of disease recurrence or death by 76% compared with platinum-based chemotherapy in people with completely resected IB (tumor ≥ 4 cm) to IIIA (UICC/AJCC 7th edition) ALK-positive NSCLC. In an exploratory analysis, an improvement of central nervous system (CNS)-disease-free survival (DFS) was observed.