Alectinib Approved for Adjuvant Treatment for ALK-Positive Non–Small Cell Lung Cancer

The FDA has granted approval to alectinib (Alecensa®, Genentech, Inc.) for adjuvant treatment following tumor resection in patients with anaplastic lymphoma kinase (ALK)–positive non–small cell lung cancer (NSCLC), as detected by an FDA-approved test.  

Why it matters: “ALK fusions represent 4% to 5% of patients with NSCLC. While we have several oral agents—tyrosine kinase inhibitors—approved for this driver alteration in the metastatic setting, use in the early-stage or adjuvant setting has not been approved until now,” wrote Morana Vojnic, MD, MBA, an Oncology Data Advisor Editorial Board Member and Assistant Professor of Medicine at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell.

What they studied: Efficacy of alectinib was measured in the phase 3, open-label, multicenter ALINA trial (NCT03456076) in which 257 patients with ALK-positive NSCLC who had complete tumor resection were enrolled. Eligibility criteria required patients to have resectable Stage IB (tumors ≥4 cm) to IIIA NSCLC (by AJCC 7th edition) with ALK rearrangements identified by an FDA-approved ALK test or by a VENTANA ALK (D5F3) CDx assay.

Patients were randomized 1:1 to receive either 600 mg of alectinib orally, twice daily or platinum-based chemotherapy following tumor resection. The primary efficacy outcomes measured, as assessed by investigators, were disease-free survival in the subgroup of patients with Stage II-IIIA NSCLC and disease-free survival in the overall study population, Stage IB-IIIA.

What they found: In the overall study population, median disease-free survival was not reached in those receiving alectinib compared with a median of 41.3 months in those receiving platinum-based chemotherapy. Additionally, in the subset of patients with Stage II-IIIA NSCLC, a similar median disease-free survival was observed; median disease-free survival was not reached in the alectinib arm compared with a median of 44.4 months in the chemotherapy arm.

Additional information: “Patients randomized to receive alectinib stayed on treatment for two years or until disease recurrence,” said Dr. Vojnic. “Disease recurrence occurred in 11.5% of patients on alectinib and 38.6% of patients on adjuvant chemotherapy, with the most common site of recurrence being the brain—4 patients with alectinib and 14 patients with chemotherapy.”

Adverse events: The most common adverse events experienced in ≥20% of those receiving alectinib were hepatotoxicity, constipation, myalgia, COVID-19, fatigue, rash, and cough.

Conclusion: “While at the time of data cutoff, the overall survival data is immature—and we are probably going to wait a few more years for that update—the disease-free survival is very encouraging and shows clear superiority to the standard adjuvant chemotherapy for this patient population,” concluded Dr. Vojnic. “The important thing to note about ALK-fusion lung cancer is its affinity to spread to the brain, so a ‘preventive’ strategy is another step in moving precision oncology to early-stage NSCLC and improving outcomes for this patient population.”

Instructions: The recommended dosage is 600 mg of alectinib orally, twice daily with food for two years or until disease recurrence or unacceptable toxicity.

For More Information

Wu YL, Dziadziuszko R, Ahn JS, et al (2024). Alectinib in resected ALK-positive non-small-cell lung cancer. N Engl J Med, 390(14):1265-1276. DOI:10.1056/NEJMoa2310532 (2024). A study comparing adjuvant alectinib versus adjuvant platinum-based chemotherapy in patients with ALK positive non-small cell lung cancer. NLM identifier: NCT03456076.

Alecensa® (alectinib) prescribing information (2024). Genentech Inc. Available at:

US Food and Drug Administration (2024). FDA approves alectinib as adjuvant treatment for ALK-positive non-small cell lung cancer. Available at:

Image credit: Yale Rosen. Licensed under CC BY-SA 2.0

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