medwireNews: Previously untreated Asian patients with advanced ALK translocation-positive non-small-cell lung cancer (NSCLC) derive a significant progression-free survival (PFS) benefit from alectinib over crizotinib, indicate phase III trial results.
In the ALESIA study, the primary endpoint of investigator-assessed median PFS was unreached for the 125 participants from China, South Korea, or Thailand who were randomly assigned to receive alectinib 600 mg twice a day for stage IIIB–IV disease, and was 11.1 months for their 62 counterparts instead given twice daily crizotinib 250 mg.
As reported in The Lancet Respiratory Medicine, the between-group difference was significant and equated to a hazard ratio for progression or death of 0.22 in favor of the second-generation ALK inhibitor alectinib.
The favorable efficacy of alectinib was also evident with regard to the secondary endpoints, such as the objective response rate and time to central nervous system (CNS) progression, report Li Zhang (Sun Yat-sen University Cancer Center, Guangzhou, China) and colleagues.
And “safety results for alectinib compared favourably with those for crizotinib,” they add, with lower rates of grade 3–5 (29 vs 48%) and serious (15 vs 26%) adverse events, despite a longer median treatment duration with alectinib (14.7 vs 12.6 months).
The researchers conclude that their results are consistent with those of the global ALEX study that used the same dose of alectinib and the Japanese J-ALEX trial using a lower dose (300 mg twice daily).
Writing in an accompanying commentary, Benjamin Besse and colleagues, from Gustave Roussy Cancer Center in Villejuif, France, say that “ALESIA confirms the attractive therapeutic index of alectinib and its position as standard of care together with other next-generation inhibitors” in this patient population.
They point out, however, that although “alectinib, like other next-generation ALK tyrosine kinase inhibitors, has shown enhanced activity in the CNS, prolonged progression-free survival and generally better tolerability, the optimal sequence strategy that will improve overall survival is yet to be elucidated.”
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