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
{"title":"Alectinib与Crizotinib在治疗无效的晚期ALK阳性NSCLC亚洲患者中的应用：3期ALESIA研究的五年最新进展","authors":"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","doi":"10.1016/j.jtocrr.2024.100700","DOIUrl":null,"url":null,"abstract":"<div><h3>Introduction</h3><p>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 <em>ALK</em>-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.</p></div><div><h3>Methods</h3><p>Adult patients with treatment-naïve, advanced <em>ALK</em>-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.</p></div><div><h3>Results</h3><p>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.</p></div><div><h3>Conclusions</h3><p>With four additional years of follow-up, these updated results confirm the clinical benefit and manageable safety of alectinib in Asian patients with advanced <em>ALK</em>-positive NSCLC, and confirm alectinib as a standard-of-care treatment for patients with advanced <em>ALK</em>-positive NSCLC.</p></div>","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":"5 9","pages":"Article 100700"},"PeriodicalIF":3.0000,"publicationDate":"2024-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2666364324000705/pdfft?md5=8879737d0464e55ddf14baed655ab7b1&pid=1-s2.0-S2666364324000705-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Alectinib Versus Crizotinib in Asian Patients With Treatment-Naïve Advanced ALK-Positive NSCLC: Five-Year Update From the Phase 3 ALESIA Study\",\"authors\":\"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\",\"doi\":\"10.1016/j.jtocrr.2024.100700\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Introduction</h3><p>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 <em>ALK</em>-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.</p></div><div><h3>Methods</h3><p>Adult patients with treatment-naïve, advanced <em>ALK</em>-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.</p></div><div><h3>Results</h3><p>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.</p></div><div><h3>Conclusions</h3><p>With four additional years of follow-up, these updated results confirm the clinical benefit and manageable safety of alectinib in Asian patients with advanced <em>ALK</em>-positive NSCLC, and confirm alectinib as a standard-of-care treatment for patients with advanced <em>ALK</em>-positive NSCLC.</p></div>\",\"PeriodicalId\":17675,\"journal\":{\"name\":\"JTO Clinical and Research Reports\",\"volume\":\"5 9\",\"pages\":\"Article 100700\"},\"PeriodicalIF\":3.0000,\"publicationDate\":\"2024-06-27\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S2666364324000705/pdfft?md5=8879737d0464e55ddf14baed655ab7b1&pid=1-s2.0-S2666364324000705-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"JTO Clinical and Research Reports\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2666364324000705\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"JTO Clinical and Research Reports","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2666364324000705","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"ONCOLOGY","Score":null,"Total":0}
Alectinib Versus Crizotinib in Asian Patients With Treatment-Naïve Advanced ALK-Positive NSCLC: Five-Year Update From the Phase 3 ALESIA Study
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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