Brigatinib Versus Crizotinib in Advanced ALK Inhibitor–Naive ALK-Positive Non–Small Cell Lung Cancer: Second Interim Analysis of the Phase III ALTA-1L Trial

克里唑蒂尼 医学 碱性抑制剂 内科学 中期分析 危险系数 间变性淋巴瘤激酶 肺癌 铈替尼 肿瘤科 临床终点 临床试验 置信区间 恶性胸腔积液
作者
D. Ross Camidge,Hye Ryun Kim,Myung‐Ju Ahn,James Chih‐Hsin Yang,Ji‐Youn Han,Maximilian J. Hochmair,Ki Hyeong Lee,Angelo Delmonte,M.R. García Campelo,Dong‐Wan Kim,Frank Griesinger,Enriqueta Felip,Raffaele Califano,Alexander I. Spira,Scott Gettinger,Marcello Tiseo,Huamao Mark Lin,Neeraj Gupta,Michael J. Hanley,Quanhong Ni
出处
期刊:Journal of Clinical Oncology [Lippincott Williams & Wilkins]
卷期号:38 (31): 3592-3603 被引量:310
标识
DOI:10.1200/jco.20.00505
摘要

Brigatinib, a next-generation anaplastic lymphoma kinase (ALK) inhibitor, demonstrated superior progression-free survival (PFS) and improved health-related quality of life (QoL) versus crizotinib in advanced ALK inhibitor-naive ALK-positive non-small cell lung cancer (NSCLC) at first interim analysis (99 events; median brigatinib follow-up, 11.0 months) in the open-label, phase III ALTA-1L trial (ClinicalTrials.gov identifier: NCT02737501). We report results of the second prespecified interim analysis (150 events).Patients with ALK inhibitor-naive advanced ALK-positive NSCLC were randomly assigned 1:1 to brigatinib 180 mg once daily (7-day lead-in at 90 mg once daily) or crizotinib 250 mg twice daily. The primary end point was PFS as assessed by blinded independent review committee (BIRC). Investigator-assessed efficacy, blood samples for pharmacokinetic assessments, and patient-reported outcomes were also collected.Two hundred seventy-five patients were randomly assigned (brigatinib, n = 137; crizotinib, n = 138). With median follow-up of 24.9 months for brigatinib (150 PFS events), brigatinib showed consistent superiority in BIRC-assessed PFS versus crizotinib (hazard ratio [HR], 0.49 [95% CI, 0.35 to 0.68]; log-rank P < .0001; median, 24.0 v 11.0 months). Investigator-assessed PFS HR was 0.43 (95% CI, 0.31 to 0.61; median, 29.4 v 9.2 months). No new safety concerns emerged. Brigatinib delayed median time to worsening of global health status/QoL scores compared with crizotinib (HR, 0.70 [95% CI, 0.49 to 1.00]; log-rank P = .049). Brigatinib daily area under the plasma concentration-time curve was not a predictor of PFS (HR, 1.005 [95% CI, 0.98 to 1.031]; P = .69).Brigatinib represents a once-daily ALK inhibitor with superior efficacy, tolerability, and QoL over crizotinib, making it a promising first-line treatment of ALK-positive NSCLC.
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