ASCO重磅:Alectinib顯示出優異的療效和良好的耐受性!有望成為一線治療ALK陽性非小細胞肺...

背景:

Alectinib是一種靶向ALK的TKI,在未使用crizotinib或對crizotinib耐藥的ALK陽性非小細胞肺癌患者中表現出強大的療效。J-ALEX在日本crizotinib-naive的ALK陽性NSCLC患者中顯示alectinib 300mg BID優于crizotinib,其中progression-free survival [PFS] HR 0.34, p的主要結果,該研究對照alectinib 600mg BID和crizotinib一線治療晚期ALK陽性的非小細胞肺癌患者。

結論:

與crizotinib相比,Alectinib顯示出優異的療效和良好的耐受性。 ALEX結果支持alectinib成為一線治療未接受過治療的ALK陽性非小細胞肺癌的新標準。

歡迎閱讀下面的ASCO摘要了解詳情!

Alectinib versus crizotinib in treatment-naive advanced ALK-positive non-small cell lung cancer (NSCLC): Primary results of the global phase III ALEX study

Sub-category:

Category:

Lung Cancer—Non-Small Cell Metastatic

Meeting:

Abstract No:

LBA9008

Citation:

J Clin Oncol 35, 2017 (suppl; abstr LBA9008)

Author(s): Alice Tsang Shaw

Background:

Alectinib, a TKI targeting ALK, has shown robust efficacy in crizotinib-na?ve/resistant ALK+ NSCLC. J-ALEX showed superiority of alectinib 300mg BID vs crizotinib in Japanese pts with crizotinib-na?ve ALK+ NSCLC (progression-free survival [PFS] HR 0.34, p

Methods:

This open-label randomized multicenter phase III study enrolled pts with stage IIIB/IV ALK+ NSCLC, determined by central IHC testing. Eligible pts had ECOG PS 0–2 and no prior systemic therapy for advanced NSCLC. Pts with asymptomatic CNS metastases were allowed. Pts (n=303) were randomized 1:1 to receive alectinib 600mg or crizotinib 250mg BID. Primary endpoint: Investigator (Inv)-assessed PFS (RECIST v1.1), with systematic CNS imaging in all pts. Secondary endpoints included independent review committee (IRC)-assessed PFS, IRC-assessed time to CNS progression (TTP), objective response rate (ORR), overall survival (OS) and safety.

Results:

At the primary data cut-off (9 Feb 2017), alectinib demonstrated statistically significant superiority vs crizotinib, reducing risk of progression/death by 53% (HR 0.47, 95% CI 0.34–0.65, p

Conclusions:

Alectinib showed superior efficacy and favorable tolerability compared with crizotinib. ALEX results support alectinib as a new standard of care for treatment-na?ve ALK+ NSCLC.

Funding:

F. Hoffmann-La Roche

Clinical trial information:

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