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Brigatinib versus Crizotinib in ALK-Positive Non–Small-Cell Lung Cancer

 D.R. Camidge  ;  H.R. Kim  ;  M.-J. Ahn  ;  J.C.-H. Yang  ;  J.-Y. Han  ;  J.-S. Lee  ;  M.J. Hochmair  ;  J.Y.-C. Li  ;  G.-C. Chang  ;  K.H. Lee  ;  C. Gridelli  ;  A. Delmonte  ;  R. Garcia Campelo  ;  D.-W. Kim  ;  A. Bearz  ;  F. Griesinger  ;  A. Morabito  ;  E. Felip  ;  R. Califano  ;  S. Ghosh  ;  A. Spira  ;  S.N. Gettinger  ;  M. Tiseo  ;  N. Gupta  ;  J. Haney  ;  D. Kerstein  ;  S. Popat 
 New England Journal of Medicine, Vol.379(21) : 2027-2039, 2018 
Journal Title
Issue Date
Adult ; Aged ; Aged, 80 and over ; Anaplastic Lymphoma Kinase/analysis ; Anaplastic Lymphoma Kinase/antagonists & inhibitors* ; Antineoplastic Agents/adverse effects ; Antineoplastic Agents/therapeutic use* ; Brain Neoplasms/secondary ; Carcinoma, Non-Small-Cell Lung/chemistry ; Carcinoma, Non-Small-Cell Lung/drug therapy* ; Carcinoma, Non-Small-Cell Lung/secondary ; Crizotinib/adverse effects ; Crizotinib/therapeutic use* ; Female ; Humans ; Kaplan-Meier Estimate ; Lung Neoplasms/chemistry ; Lung Neoplasms/drug therapy* ; Lung Neoplasms/pathology ; Male ; Middle Aged ; Organophosphorus Compounds/adverse effects ; Organophosphorus Compounds/therapeutic use* ; Progression-Free Survival ; Pyrimidines/adverse effects ; Pyrimidines/therapeutic use*
BACKGROUND: Brigatinib, a next-generation anaplastic lymphoma kinase (ALK) inhibitor, has robust efficacy in patients with ALK-positive non-small-cell lung cancer (NSCLC) that is refractory to crizotinib. The efficacy of brigatinib, as compared with crizotinib, in patients with advanced ALK-positive NSCLC who have not previously received an ALK inhibitor is unclear.

METHODS: In an open-label, phase 3 trial, we randomly assigned, in a 1:1 ratio, patients with advanced ALK-positive NSCLC who had not previously received ALK inhibitors to receive brigatinib at a dose of 180 mg once daily (with a 7-day lead-in period at 90 mg) or crizotinib at a dose of 250 mg twice daily. The primary end point was progression-free survival as assessed by blinded independent central review. Secondary end points included the objective response rate and intracranial response. The first interim analysis was planned when approximately 50% of 198 expected events of disease progression or death had occurred.

RESULTS: A total of 275 patients underwent randomization; 137 were assigned to brigatinib and 138 to crizotinib. At the first interim analysis (99 events), the median follow-up was 11.0 months in the brigatinib group and 9.3 months in the crizotinib group. The rate of progression-free survival was higher with brigatinib than with crizotinib (estimated 12-month progression-free survival, 67% [95% confidence interval {CI}, 56 to 75] vs. 43% [95% CI, 32 to 53]; hazard ratio for disease progression or death, 0.49 [95% CI, 0.33 to 0.74]; P<0.001 by the log-rank test). The confirmed objective response rate was 71% (95% CI, 62 to 78) with brigatinib and 60% (95% CI, 51 to 68) with crizotinib; the confirmed rate of intracranial response among patients with measurable lesions was 78% (95% CI, 52 to 94) and 29% (95% CI, 11 to 52), respectively. No new safety concerns were noted.

CONCLUSIONS: Among patients with ALK-positive NSCLC who had not previously received an ALK inhibitor, progression-free survival was significantly longer among patients who received brigatinib than among those who received crizotinib. (Funded by Ariad Pharmaceuticals; ALTA-1L ClinicalTrials.gov number, NCT02737501 .).
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Hye Ryun(김혜련) ORCID logo https://orcid.org/0000-0002-1842-9070
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