JTO Clinical and Research Reports (Sep 2024)

Alectinib Versus Crizotinib in Asian Patients With Treatment-Naïve Advanced ALK-Positive NSCLC: Five-Year Update From the Phase 3 ALESIA Study

  • Caicun Zhou, MD, PhD,
  • You Lu, MD,
  • Sang-We Kim, MD, PhD,
  • Thanyanan Reungwetwattana, MD,
  • Jianying Zhou, MD,
  • Yiping Zhang, MD,
  • Jianxing He, MD, PhD,
  • Jin-Ji Yang, MD,
  • Ying Cheng, MD,
  • Se-Hoon Lee, MD, PhD,
  • Jianhua Chang, MD,
  • Jian Fang, MD,
  • Zhe Liu, PhD,
  • Lilian Bu, MSc,
  • Li Qian, MD,
  • Tingting Xu, MD,
  • Venice Archer, MB ChB, MSc,
  • Magalie Hilton, MSc,
  • Mingzhu Zhou, MSc,
  • Li Zhang, MD

Journal volume & issue
Vol. 5, no. 9
p. 100700

Abstract

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Introduction: Previous results from the phase 3 ALESIA study (NCT02838420) revealed that alectinib (a central nervous system [CNS]-active, ALK inhibitor) had clinical benefits in treatment-naïve Asian patients with advanced ALK-positive NSCLC, consistent with the global ALEX study. We present updated data after more than or equal to 5 years of follow-up from the “last patient in” date. Methods: Adult patients with treatment-naïve, advanced ALK-positive NSCLC from mainland China, South Korea, and Thailand were randomized 2:1 to receive twice-daily 600 mg alectinib (n = 125) or 250 mg crizotinib (n = 62). The primary endpoint was investigator-assessed progression-free survival. Secondary or exploratory endpoints included overall survival, objective response rate, time to CNS progression, and safety. Results: At the data cutoff (May 16, 2022), the median survival follow-up was 61 and 51 months in the alectinib and crizotinib arms, respectively. Median progression-free survival was 41.6 months with alectinib versus 11.1 months with crizotinib (stratified hazard ratio = 0.33, 95% confidence interval: 0.23–0.49). Overall survival data remain immature; 5-year overall survival rates were 66.4% (alectinib arm) versus 56.1% (crizotinib arm). Objective response rate was 91.2% versus 77.4% with alectinib and crizotinib, respectively. CNS progression was delayed with alectinib versus crizotinib (cause-specific hazard ratio = 0.16, 95% confidence interval: 0.08–0.32). Median treatment duration was longer with alectinib versus crizotinib (42.3 versus 12.6 mo). No new safety signals were observed. Conclusions: With four additional years of follow-up, these updated results confirm the clinical benefit and manageable safety of alectinib in Asian patients with advanced ALK-positive NSCLC, and confirm alectinib as a standard-of-care treatment for patients with advanced ALK-positive NSCLC.

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