Site Editor
Gregory J. Riely, MD, PhD
Gregory J. Riely, MD, PhD
Posted: Friday, April 19, 2024
Yesterday, the U.S. Food and Drug Administration (FDA) approved alectinib (Alecensa) for adjuvant treatment after tumor resection in patients with ALK-positive non–small cell lung cancer (NSCLC), as detected by an FDA-approved test. In December 2015, this ALK inhibitor received accelerated approval for treatment of patients with ALK-positive metastatic NSCLC who experienced disease progression on or were intolerant of the tyrosine kinase inhibitor crizotinib.
The recent indication was based on results from the global, randomized, open-label ALINA trial. Eligible patients were required to have resectable stage IB (tumors ≥ 4 cm) to IIIA NSCLC with ALK rearrangements identified by a locally performed FDA-approved test or a centrally performed VENTANA ALK (D5F3) CDx assay. A total of 257 patients were randomly assigned (1:1) to receive alectinib at 600 mg orally twice daily or platinum-based chemotherapy after tumor resection.
In the subgroup of patients with stage II to IIIA NSCLC, median disease-free survival was not reached (95% confidence interval [CI] = not estimable [NE] to NE) in the alectinib arm and 44.4 months (95% CI = 27.8 months to NE) in the chemotherapy arm (hazard ratio [HR] = 0.24 [95% CI = 0.13–0.45]; P < .0001). Similar results were seen in the overall study population (stage IB to IIIA), with median disease-free survival not reached (95% CI = NE to NE) in the alectinib arm and 41.3 months (95% CI = 28.5 months to NE) in the chemotherapy arm (HR = 0.24 [95% CI = 0.13–0.43]; P < .0001).
The most common (≥ 20%) adverse reactions in patients taking alectinib were hepatotoxicity, constipation, myalgia, COVID-19 infection, fatigue, rash, and cough.
The recommended alectinib dose is 600 mg orally twice daily with food for 2 years or until disease recurrence or unacceptable toxicity.
U.S. Food and Drug Administration
JNCCN Spotlights
