Alectinib Versus Crizotinib in Asian Patients With Treatment-Naïve Advanced ALK-Positive NSCLC: Five-Year Update From the Phase 3 ALESIA Study
Issued Date
2024-09-01
Resource Type
eISSN
26663643
Scopus ID
2-s2.0-85202200401
Journal Title
JTO Clinical and Research Reports
Volume
5
Issue
9
Rights Holder(s)
SCOPUS
Bibliographic Citation
JTO Clinical and Research Reports Vol.5 No.9 (2024)
Suggested Citation
Zhou C., Lu Y., Kim S.W., Reungwetwattana T., Zhou J., Zhang Y., He J., Yang J.J., Cheng Y., Lee S.H., Chang J., Fang J., Liu Z., Bu L., Qian L., Xu T., Archer V., Hilton M., Zhou M., Zhang L. Alectinib Versus Crizotinib in Asian Patients With Treatment-Naïve Advanced ALK-Positive NSCLC: Five-Year Update From the Phase 3 ALESIA Study. JTO Clinical and Research Reports Vol.5 No.9 (2024). doi:10.1016/j.jtocrr.2024.100700 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/100707
Title
Alectinib Versus Crizotinib in Asian Patients With Treatment-Naïve Advanced ALK-Positive NSCLC: Five-Year Update From the Phase 3 ALESIA Study
Author's Affiliation
Chinese Academy of Medical Sciences & Peking Union Medical College
Sun Yat-Sen University Cancer Center
Beijing Chest Hospital, Capital Medical University
Tongji University
Zhejiang Cancer Hospital
West China School of Medicine/West China Hospital of Sichuan University
Guangdong Provincial People’s Hospital of Southern Medical University
Asan Medical Center
Zhejiang University School of Medicine
Samsung Medical Center, Sungkyunkwan university
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Guangzhou Medical University
Beijing Cancer Hospital
F. Hoffmann-La Roche AG
Roche Products Limited UK
Jilin Cancer Hospital
Roche (China) Holding Ltd
Sun Yat-Sen University Cancer Center
Beijing Chest Hospital, Capital Medical University
Tongji University
Zhejiang Cancer Hospital
West China School of Medicine/West China Hospital of Sichuan University
Guangdong Provincial People’s Hospital of Southern Medical University
Asan Medical Center
Zhejiang University School of Medicine
Samsung Medical Center, Sungkyunkwan university
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Guangzhou Medical University
Beijing Cancer Hospital
F. Hoffmann-La Roche AG
Roche Products Limited UK
Jilin Cancer Hospital
Roche (China) Holding Ltd
Corresponding Author(s)
Other Contributor(s)
Abstract
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.