- Front-line alectinib yielded superior progression-free survival (PFS) and objective response rate (ORR) vs crizotinib in a study of Asian patients with anaplastic lymphoma kinase (ALK)-positive NSCLC.
Why this matters
- This is the first trial to compare alectinib at a dose of 600 mg twice a day with crizotinib for ALK-positive NSCLC in an all-Asian cohort.
- A prior study, the ALEX trial, compared the 2 treatments in a subgroup of Japanese patients, but the alectinib dose was 300 mg twice a day.
- Randomized, international, phase 3 ALESIA study.
- 187 patients with stage IIIb-IV ALK-positive NSCLC received alectinib (n=125) or crizotinib (n=62).
- Funding: F. Hoffmann-La Roche.
- PFS was significantly longer with alectinib than crizotinib (investigator-assessed HR, 0.22 [P<.0001 review committee-assessed hr>
- Alectinib yielded a higher objective response rate (91% vs 77%; P=.0095) and a longer duration of response (HR, 0.22; P<.0001 than crizotinib.>
- Alectinib significantly decreased the risk for central nervous system (CNS) progression without previous non-CNS progression vs crizotinib (cause-specific HR, 0.14; 95% CI, 0.06-0.30).
- Grade 3-5 adverse events (AEs; 48% vs 29%) and serious AEs (26% vs 15%) were more common with crizotinib.
- Open-label study with immature OS data.