Brigatinib Versus Crizotinib in ALK Inhibitor–Naive Advanced ALK-Positive NSCLC: Final Results of Phase 3 ALTA-1L Trial

克里唑蒂尼 医学 内科学 危险系数 碱性抑制剂 肺癌 肿瘤科 临床终点 置信区间 临床试验 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,Yuyin Liu,Florin Vranceanu,Huifeng Niu
出处
期刊:Journal of Thoracic Oncology [Elsevier BV]
卷期号:16 (12): 2091-2108 被引量:285
标识
DOI:10.1016/j.jtho.2021.07.035
摘要

In the phase 3 study entitled ALK in Lung cancer Trial of brigAtinib in 1st Line (ALTA-1L), which is a study of brigatinib in ALK inhibitor-naive advanced ALK-positive NSCLC, brigatinib exhibited superior progression-free survival (PFS) versus crizotinib in the two planned interim analyses. Here, we report the final efficacy, safety, and exploratory results.Patients were randomized to brigatinib 180 mg once daily (7-d lead-in at 90 mg once daily) or crizotinib 250 mg twice daily. The primary end point was a blinded independent review committee-assessed PFS. Genetic alterations in plasma cell-free DNA were assessed in relation to clinical efficacy.A total of 275 patients were enrolled (brigatinib, n = 137; crizotinib, n = 138). At study end, (brigatinib median follow-up = 40.4 mo), the 3-year PFS by blinded independent review committee was 43% (brigatinib) versus 19% (crizotinib; median = 24.0 versus 11.1 mo, hazard ratio [HR] = 0.48, 95% confidence interval [CI]: 0.35-0.66). The median overall survival was not reached in either group (HR = 0.81, 95% CI: 0.53-1.22). Posthoc analyses suggested an overall survival benefit for brigatinib in patients with baseline brain metastases (HR = 0.43, 95% CI: 0.21-0.89). Detectable baseline EML4-ALK fusion variant 3 and TP53 mutation in plasma were associated with poor PFS. Brigatinib exhibited superior efficacy compared with crizotinib regardless of EML4-ALK variant and TP53 mutation. Emerging secondary ALK mutations were rare in patients progressing on brigatinib. No new safety signals were observed.In the ALTA-1L final analysis, with longer follow-up, brigatinib continued to exhibit superior efficacy and tolerability versus crizotinib in patients with or without poor prognostic biomarkers. The suggested survival benefit with brigatinib in patients with brain metastases warrants future study.
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