ALK+ NSCLC: frontline alectinib tops crizotinib in all-Asian trial

  • Zhou C & al.
  • Lancet Respir Med
  • 10 Apr 2019

  • curated by Kelli Whitlock Burton
  • Univadis Clinical Summaries
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Takeaway

  • 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.

Study design

  • 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.

Key results

  • 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.

Limitations

  • Open-label study with immature OS data.

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