Alecensa Approved as Adjuvant Treatment for ALK-Positive Early-Stage NSCLC

The Food and Drug Administration (FDA) has approved Alecensa (alectinib) for adjuvant treatment in adults following tumor resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors ≥4cm or node positive) as detected by an FDA-approved test.

The approval was based on data from the randomized, active-controlled, open-label, phase 3 ALINA study (ClinicalTrials.gov Identifier: NCT03456076), which evaluated the efficacy and safety of alectinib in 257 adults with ALK-positive NSCLC (tumors ≥4cm or node positive) following complete tumor resection. Study participants were randomly assigned 1:1 to receive either alectinib 600mg orally twice daily or platinum-based chemotherapy.

The major efficacy outcome measures were disease-free survival (DFS) in patients with stage II-IIIA NSCLC and in patients with stage IB-IIIA NSCLC (intent-to-treat [ITT] population). DFS was defined as the time from date of randomization to the date of occurrence of any of the following: first documented recurrence of disease, new primary NSCLC, or death due to any cause, whichever occurred first. 

Results showed treatment with alectinib reduced the risk of disease recurrence or death by 76% in the ITT population compared with chemotherapy (hazard ratio [HR], 0.24; 95% CI, 0.13-0.43; P <.0001). Median DFS was not reached (95% CI, not estimable [NE], NE) in the alectinib arm and was 41.3 months (95% CI, 28.5, NE) in the chemotherapy arm.

In the stage II-IIIA population, median DFS was not reached (95% CI, NE, NE) in the alectinib arm and was 44.4 months (95% CI, 27.8, NE) in the chemotherapy arm (HR 0.24 [95% CI, 0.13-0.45]; P <.0001).

In an exploratory analysis of site(s) of relapse, 3.1% of patients (n=4) in the alectinib arm and 11% of patients (n=14) in the chemotherapy arm had brain involvement at the time of disease recurrence. Overall survival data were not mature at the time of DFS analysis.

The most common adverse reactions reported in patients taking alectinib were hepatotoxicity, constipation, myalgia, COVID-19, fatigue, rash, and cough.

Alecensa, a kinase inhibitor, is also indicated for the treatment of adults with ALK-positive metastatic NSCLC as detected by an FDA-approved test.