ALK inhibitor improves DFS in ALK-positive NSCLC
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Key takeaways:
- Alectinib significantly improved DFS in patients with completely resected ALK-positive NSCLC compared with chemotherapy alone.
- Researchers did not observe any unexpected safety events with alectinib.
MADRID — Alectinib significantly improved DFS compared with chemotherapy alone in patients with resected ALK-positive non-small cell lung cancer, according to research presented at ESMO Congress 2023.
“About 30% to 40% of patients with NSCLC are diagnosed with early-stage, potentially resectable disease,” Benjamin J. Solomon, MBBS, PhD, of Peter MacCallum Cancer Centre and University of Melbourne, said during the presentation. “But we know that despite treatment, recurrence rates remain high.”
Solomon discussed results from the ALINA trial, a global, phase 3, open-label randomized trial that assessed the use of alectinib (Alecensa, Genentech) in patients with resected ALK-positive NSCLC compared with chemotherapy alone.
Researchers enrolled patients who were aged 18 years or older with completely resected stage IB through IIIA ALK-positive NSCLC. These patients were randomized 1:1 to receive either oral alectinib at 600 mg twice per day (n = 130) or chemotherapy, up to four 21-day cycles of IV platinum based chemotherapy (n = 127). Randomization was stratified by stage of disease and race.
Patients randomized to alectinib received it for up to 24 months or until disease recurrence, withdrawal of consent or unacceptable toxicity. Patients’ baseline characteristics were well-balanced between both treatment arms. At the data cut off on June 26, 2023, the median follow-up was 27.8 months.
Researchers noted that they observed a significant benefit in DFS between patients who received alectinib compared with those who received chemotherapy among patients who were stage II-IIA (HR = 0.24; 95% CI, 0.13-0.45) and in the intent-to-treat population (HR = 0.24; 95% CI, 0.13-0.43).
Solomon explained that they also observed a clinically meaningful central nervous system DFS benefit in the ITT patient population, but that the data was immature (HR = 0.22; 95% CI, 0.08-0.58).
Researchers did not observe any unexpected safety findings.
“ALINA is the first phase 3 trial of an ALK inhibitor in resected stage IB to IIIA NSCLC,” Solomon said. “Treatment with adjuvant alectinib resulted in a statistically significant and clinically meaningful improvement in disease-free survival compared with chemotherapy.”
Solomon concluded that “alectinib represents an important, new treatment strategy for patients with resected, stage IB to IIIA ALK-positive NSCLC.”
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Solomon BJ, et al. Abstract LBA2. Presented at: European Society for Medical Oncology Congress; Oct. 20-24, 2023; Madrid.
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