Phase I/II study of alectinib (CH5424802/RO5424802) in patients with alk-rearranged non-small cell lung cancer (NSCLC): Updated results from the AF-001JP trial

Hiroshige Yoshioka, Makoto Nishio, Katsuyuki Kiura, Takashi Seto, Kazuhiko Nakagawa, Makoto Maemondo, Akira Inoue, Toyoaki Hida, Tomohiro Tanaka, Tomohide Tamura

Research output: Contribution to journalArticle

Abstract

Purpose. We investigated the efficacy and safety of the long-term administration of a highly selective anaplastic lymphoma kinase (ALK) inhibitor with a novel scaffold, alectinib, in Japanese patients with ALKrearranged non-small cell lung cancer (NSCLC). Methods. ALK-rearranged NSCLC patients (Pts) naive to ALK inhibitors were treated with alectinib at a dose of 300 mg b.i.d until on the onset of progressive disease. We herein report the efficacy and safety of this treatment according to an independent review at the one-year time point after enrollment of the last patient (as of April 18, 2013). Results. Among the 46 pts in assessed in the phase II portion of this study, the overall response rate was 93.5%(95%CI: 82.1-98.6). The one-year progression free rate was 83% (95%CI: 68-92), although the median progression free survival (PFS) had not been reached at the time of cutoff date. Among the 58 pts treated with alectinib at a dose of 300 mg b.i.d in the phase I and II portions of the AF-001JP study, 42 (72%) remained on the study regimen, with a median treatment duration of 15.8 months. Major treatment-related adverse events included dysgeusia, rashes and increased AST and blood bilirubin levels, mostly of grade 1-2. Conclusions. Alectinib demonstrates long-term efficacy and a favorable benefit-risk profile in ALK inhibitor-naive patients with ALK-rearranged NSCLC.

Original languageEnglish
Pages (from-to)892-897
Number of pages6
JournalJapanese Journal of Lung Cancer
Volume54
Issue number7
Publication statusPublished - Dec 20 2014

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Non-Small Cell Lung Carcinoma
Dysgeusia
Safety
Exanthema
Bilirubin
Disease-Free Survival
anaplastic lymphoma kinase
CH5424802
Therapeutics

Keywords

  • Alectinib
  • Anaplastic lymphoma kinase (ALK)
  • Non-small cell lung cancer (NSCLC)

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine

Cite this

Phase I/II study of alectinib (CH5424802/RO5424802) in patients with alk-rearranged non-small cell lung cancer (NSCLC) : Updated results from the AF-001JP trial. / Yoshioka, Hiroshige; Nishio, Makoto; Kiura, Katsuyuki; Seto, Takashi; Nakagawa, Kazuhiko; Maemondo, Makoto; Inoue, Akira; Hida, Toyoaki; Tanaka, Tomohiro; Tamura, Tomohide.

In: Japanese Journal of Lung Cancer, Vol. 54, No. 7, 20.12.2014, p. 892-897.

Research output: Contribution to journalArticle

Yoshioka, H, Nishio, M, Kiura, K, Seto, T, Nakagawa, K, Maemondo, M, Inoue, A, Hida, T, Tanaka, T & Tamura, T 2014, 'Phase I/II study of alectinib (CH5424802/RO5424802) in patients with alk-rearranged non-small cell lung cancer (NSCLC): Updated results from the AF-001JP trial', Japanese Journal of Lung Cancer, vol. 54, no. 7, pp. 892-897.
Yoshioka, Hiroshige ; Nishio, Makoto ; Kiura, Katsuyuki ; Seto, Takashi ; Nakagawa, Kazuhiko ; Maemondo, Makoto ; Inoue, Akira ; Hida, Toyoaki ; Tanaka, Tomohiro ; Tamura, Tomohide. / Phase I/II study of alectinib (CH5424802/RO5424802) in patients with alk-rearranged non-small cell lung cancer (NSCLC) : Updated results from the AF-001JP trial. In: Japanese Journal of Lung Cancer. 2014 ; Vol. 54, No. 7. pp. 892-897.
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abstract = "Purpose. We investigated the efficacy and safety of the long-term administration of a highly selective anaplastic lymphoma kinase (ALK) inhibitor with a novel scaffold, alectinib, in Japanese patients with ALKrearranged non-small cell lung cancer (NSCLC). Methods. ALK-rearranged NSCLC patients (Pts) naive to ALK inhibitors were treated with alectinib at a dose of 300 mg b.i.d until on the onset of progressive disease. We herein report the efficacy and safety of this treatment according to an independent review at the one-year time point after enrollment of the last patient (as of April 18, 2013). Results. Among the 46 pts in assessed in the phase II portion of this study, the overall response rate was 93.5{\%}(95{\%}CI: 82.1-98.6). The one-year progression free rate was 83{\%} (95{\%}CI: 68-92), although the median progression free survival (PFS) had not been reached at the time of cutoff date. Among the 58 pts treated with alectinib at a dose of 300 mg b.i.d in the phase I and II portions of the AF-001JP study, 42 (72{\%}) remained on the study regimen, with a median treatment duration of 15.8 months. Major treatment-related adverse events included dysgeusia, rashes and increased AST and blood bilirubin levels, mostly of grade 1-2. Conclusions. Alectinib demonstrates long-term efficacy and a favorable benefit-risk profile in ALK inhibitor-naive patients with ALK-rearranged NSCLC.",
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AU - Nishio, Makoto

AU - Kiura, Katsuyuki

AU - Seto, Takashi

AU - Nakagawa, Kazuhiko

AU - Maemondo, Makoto

AU - Inoue, Akira

AU - Hida, Toyoaki

AU - Tanaka, Tomohiro

AU - Tamura, Tomohide

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