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ALEX Study Update on Alectinib for ALK-Positive Non–Small Cell Lung Cancer

By: Julia Fiederlein
Posted: Monday, August 24, 2020

Patients with ALK-positive non–small cell lung cancer (NSCLC) may benefit from treatment with the ALK inhibitor alectinib compared with the first-generation tyrosine kinase inhibitor crizotinib, according to Solange Peters, MD, PhD, of the Lausanne University Hospital, Switzerland, and colleagues. The 5-year updated findings of the ALEX study were published in the Annals of Oncology.

“The ALEX study demonstrated significantly improved progression-free survival with alectinib versus crizotinib in treatment-naive ALK-positive NSCLC at the primary data cutoff,” the investigators remarked. “[The updated results support] the current recommendation by multiple national treatment guidelines of using a next-generation anaplastic lymphoma kinase–tyrosine kinase inhibitor first-line therapy in this patient population, with alectinib indicated as the preferred option.”

 A total of 303 patients with previously untreated stage III or IV ALK-positive NSCLC participated in the study. Of the enrolled patients, 122 had central nervous system metastases. In a 1:1 allocation ratio, the patients were randomly assigned to receive either alectinib (n = 152) or crizotinib (n = 151) twice daily.

The mature median duration of progression-free survival appeared to be significantly higher with alectinib than crizotinib (34.8 vs. 10.9 months, respectively). The median overall survival with crizotinib was 57.4 months; however, the median overall survival with alectinib has not yet been reached. The 5-year overall survival rates in the alectinib and crizotinib treatment arms were 62.5% versus 45.5%, respectively. More patients in the alectinib arm continued treatment up to this point (34.9% vs. 8.6%, respectively). Patients with (hazard ratio = 0.58) and without (hazard ratio = 0.76) central nervous system metastases seemed to derive an overall survival benefit from treatment with alectinib. The median durations of treatment in the alectinib and crizotinib arms were 28.1 versus 10.8 months, respectively. The updated safety profile appeared to be congruent with previous reports.

Disclosure: For full disclosures of the study authors, visit sciencedirect.com.



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