Final progression-free survival results from the J-ALEX study of alectinib versus crizotinib in ALK-positive non-small-cell lung cancer

Kazuhiko Nakagawa, Toyoaki Hida, Hiroshi Nokihara, Masahiro Morise, Koichi Azuma, Young Hak Kim, Takashi Seto, Yuichi Takiguchi, Makoto Nishio, Hiroshige Yoshioka, Toru Kumagai, Katsuyuki Hotta, Satoshi Watanabe, Koichi Goto, Miyako Satouchi, Toshiyuki Kozuki, Ryo Koyama, Tetsuya Mitsudomi, Nobuyuki Yamamoto, Takashi AsakawaMorihiko Hayashi, Wakako Hasegawa, Tomohide Tamura

Research output: Contribution to journalArticle

Abstract

OBJECTIVES: The J-ALEX study compared the efficacy and safety of alectinib with crizotinib in Japanese patients with advanced ALK-positive non-small-cell lung cancer (NSCLC). Superiority in independent review facility (IRF)-assessed progression-free survival (PFS) was demonstrated for alectinib at the second pre-planned interim PFS analysis (data cutoff: December 3, 2015; hazard ratio [HR] 0.34, 99.7 % confidence interval [CI]: 0.17-0.71, P < 0.0001). We report final PFS data and the second pre-planned interim analysis of overall survival (OS) and safety (data cutoff: June 30, 2018). METHODS: Patients aged ≥20 years who were ALK inhibitor-naïve and chemotherapy-naïve, or had received one prior chemotherapy regimen, were randomized to receive alectinib 300 mg (n = 103) or crizotinib 250 mg (n = 104) twice daily. The primary end point was IRF-assessed PFS. Secondary end points included OS and safety. All patients entered survival follow-up in July 2018. RESULTS: Median follow-up was 42.4 months for alectinib and 42.2 months for crizotinib. Sustained improvement in IRF-assessed PFS with alectinib was shown (HR 0.37, 95 % CI: 0.26-0.52; median PFS 34.1 months vs 10.2 months crizotinib). At the second interim OS analysis, superiority of alectinib to crizotinib could not be concluded (stratified HR 0.80, 99.8799 % CI: 0.35-1.82, stratified log-rank P = 0.3860; median OS not reached alectinib vs 43.7 months crizotinib). Fewer alectinib-treated patients experienced grade ≥3 adverse events (36.9 % vs 60.6 % crizotinib). CONCLUSIONS: At the final PFS analysis, alectinib continued to demonstrate superiority in IRF-assessed PFS versus crizotinib in ALK-inhibitor-naïve ALK-positive NSCLC, with a favorable safety profile. OS follow-up continues.

Original languageEnglish
Pages (from-to)195-199
Number of pages5
JournalLung cancer (Amsterdam, Netherlands)
Volume139
DOIs
Publication statusPublished - Jan 1 2020

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Non-Small Cell Lung Carcinoma
Disease-Free Survival
Survival Analysis
Safety
Survival
Confidence Intervals
crizotinib
CH5424802
Drug Therapy

Keywords

  • Alectinib
  • ALK-positive
  • Crizotinib
  • J-ALEX
  • NSCLC
  • PFS

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

Cite this

Final progression-free survival results from the J-ALEX study of alectinib versus crizotinib in ALK-positive non-small-cell lung cancer. / Nakagawa, Kazuhiko; Hida, Toyoaki; Nokihara, Hiroshi; Morise, Masahiro; Azuma, Koichi; Kim, Young Hak; Seto, Takashi; Takiguchi, Yuichi; Nishio, Makoto; Yoshioka, Hiroshige; Kumagai, Toru; Hotta, Katsuyuki; Watanabe, Satoshi; Goto, Koichi; Satouchi, Miyako; Kozuki, Toshiyuki; Koyama, Ryo; Mitsudomi, Tetsuya; Yamamoto, Nobuyuki; Asakawa, Takashi; Hayashi, Morihiko; Hasegawa, Wakako; Tamura, Tomohide.

In: Lung cancer (Amsterdam, Netherlands), Vol. 139, 01.01.2020, p. 195-199.

Research output: Contribution to journalArticle

Nakagawa, K, Hida, T, Nokihara, H, Morise, M, Azuma, K, Kim, YH, Seto, T, Takiguchi, Y, Nishio, M, Yoshioka, H, Kumagai, T, Hotta, K, Watanabe, S, Goto, K, Satouchi, M, Kozuki, T, Koyama, R, Mitsudomi, T, Yamamoto, N, Asakawa, T, Hayashi, M, Hasegawa, W & Tamura, T 2020, 'Final progression-free survival results from the J-ALEX study of alectinib versus crizotinib in ALK-positive non-small-cell lung cancer', Lung cancer (Amsterdam, Netherlands), vol. 139, pp. 195-199. https://doi.org/10.1016/j.lungcan.2019.11.025
Nakagawa, Kazuhiko ; Hida, Toyoaki ; Nokihara, Hiroshi ; Morise, Masahiro ; Azuma, Koichi ; Kim, Young Hak ; Seto, Takashi ; Takiguchi, Yuichi ; Nishio, Makoto ; Yoshioka, Hiroshige ; Kumagai, Toru ; Hotta, Katsuyuki ; Watanabe, Satoshi ; Goto, Koichi ; Satouchi, Miyako ; Kozuki, Toshiyuki ; Koyama, Ryo ; Mitsudomi, Tetsuya ; Yamamoto, Nobuyuki ; Asakawa, Takashi ; Hayashi, Morihiko ; Hasegawa, Wakako ; Tamura, Tomohide. / Final progression-free survival results from the J-ALEX study of alectinib versus crizotinib in ALK-positive non-small-cell lung cancer. In: Lung cancer (Amsterdam, Netherlands). 2020 ; Vol. 139. pp. 195-199.
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abstract = "OBJECTIVES: The J-ALEX study compared the efficacy and safety of alectinib with crizotinib in Japanese patients with advanced ALK-positive non-small-cell lung cancer (NSCLC). Superiority in independent review facility (IRF)-assessed progression-free survival (PFS) was demonstrated for alectinib at the second pre-planned interim PFS analysis (data cutoff: December 3, 2015; hazard ratio [HR] 0.34, 99.7 {\%} confidence interval [CI]: 0.17-0.71, P < 0.0001). We report final PFS data and the second pre-planned interim analysis of overall survival (OS) and safety (data cutoff: June 30, 2018). METHODS: Patients aged ≥20 years who were ALK inhibitor-na{\"i}ve and chemotherapy-na{\"i}ve, or had received one prior chemotherapy regimen, were randomized to receive alectinib 300 mg (n = 103) or crizotinib 250 mg (n = 104) twice daily. The primary end point was IRF-assessed PFS. Secondary end points included OS and safety. All patients entered survival follow-up in July 2018. RESULTS: Median follow-up was 42.4 months for alectinib and 42.2 months for crizotinib. Sustained improvement in IRF-assessed PFS with alectinib was shown (HR 0.37, 95 {\%} CI: 0.26-0.52; median PFS 34.1 months vs 10.2 months crizotinib). At the second interim OS analysis, superiority of alectinib to crizotinib could not be concluded (stratified HR 0.80, 99.8799 {\%} CI: 0.35-1.82, stratified log-rank P = 0.3860; median OS not reached alectinib vs 43.7 months crizotinib). Fewer alectinib-treated patients experienced grade ≥3 adverse events (36.9 {\%} vs 60.6 {\%} crizotinib). CONCLUSIONS: At the final PFS analysis, alectinib continued to demonstrate superiority in IRF-assessed PFS versus crizotinib in ALK-inhibitor-na{\"i}ve ALK-positive NSCLC, with a favorable safety profile. OS follow-up continues.",
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TY - JOUR

T1 - Final progression-free survival results from the J-ALEX study of alectinib versus crizotinib in ALK-positive non-small-cell lung cancer

AU - Nakagawa, Kazuhiko

AU - Hida, Toyoaki

AU - Nokihara, Hiroshi

AU - Morise, Masahiro

AU - Azuma, Koichi

AU - Kim, Young Hak

AU - Seto, Takashi

AU - Takiguchi, Yuichi

AU - Nishio, Makoto

AU - Yoshioka, Hiroshige

AU - Kumagai, Toru

AU - Hotta, Katsuyuki

AU - Watanabe, Satoshi

AU - Goto, Koichi

AU - Satouchi, Miyako

AU - Kozuki, Toshiyuki

AU - Koyama, Ryo

AU - Mitsudomi, Tetsuya

AU - Yamamoto, Nobuyuki

AU - Asakawa, Takashi

AU - Hayashi, Morihiko

AU - Hasegawa, Wakako

AU - Tamura, Tomohide

PY - 2020/1/1

Y1 - 2020/1/1

N2 - OBJECTIVES: The J-ALEX study compared the efficacy and safety of alectinib with crizotinib in Japanese patients with advanced ALK-positive non-small-cell lung cancer (NSCLC). Superiority in independent review facility (IRF)-assessed progression-free survival (PFS) was demonstrated for alectinib at the second pre-planned interim PFS analysis (data cutoff: December 3, 2015; hazard ratio [HR] 0.34, 99.7 % confidence interval [CI]: 0.17-0.71, P < 0.0001). We report final PFS data and the second pre-planned interim analysis of overall survival (OS) and safety (data cutoff: June 30, 2018). METHODS: Patients aged ≥20 years who were ALK inhibitor-naïve and chemotherapy-naïve, or had received one prior chemotherapy regimen, were randomized to receive alectinib 300 mg (n = 103) or crizotinib 250 mg (n = 104) twice daily. The primary end point was IRF-assessed PFS. Secondary end points included OS and safety. All patients entered survival follow-up in July 2018. RESULTS: Median follow-up was 42.4 months for alectinib and 42.2 months for crizotinib. Sustained improvement in IRF-assessed PFS with alectinib was shown (HR 0.37, 95 % CI: 0.26-0.52; median PFS 34.1 months vs 10.2 months crizotinib). At the second interim OS analysis, superiority of alectinib to crizotinib could not be concluded (stratified HR 0.80, 99.8799 % CI: 0.35-1.82, stratified log-rank P = 0.3860; median OS not reached alectinib vs 43.7 months crizotinib). Fewer alectinib-treated patients experienced grade ≥3 adverse events (36.9 % vs 60.6 % crizotinib). CONCLUSIONS: At the final PFS analysis, alectinib continued to demonstrate superiority in IRF-assessed PFS versus crizotinib in ALK-inhibitor-naïve ALK-positive NSCLC, with a favorable safety profile. OS follow-up continues.

AB - OBJECTIVES: The J-ALEX study compared the efficacy and safety of alectinib with crizotinib in Japanese patients with advanced ALK-positive non-small-cell lung cancer (NSCLC). Superiority in independent review facility (IRF)-assessed progression-free survival (PFS) was demonstrated for alectinib at the second pre-planned interim PFS analysis (data cutoff: December 3, 2015; hazard ratio [HR] 0.34, 99.7 % confidence interval [CI]: 0.17-0.71, P < 0.0001). We report final PFS data and the second pre-planned interim analysis of overall survival (OS) and safety (data cutoff: June 30, 2018). METHODS: Patients aged ≥20 years who were ALK inhibitor-naïve and chemotherapy-naïve, or had received one prior chemotherapy regimen, were randomized to receive alectinib 300 mg (n = 103) or crizotinib 250 mg (n = 104) twice daily. The primary end point was IRF-assessed PFS. Secondary end points included OS and safety. All patients entered survival follow-up in July 2018. RESULTS: Median follow-up was 42.4 months for alectinib and 42.2 months for crizotinib. Sustained improvement in IRF-assessed PFS with alectinib was shown (HR 0.37, 95 % CI: 0.26-0.52; median PFS 34.1 months vs 10.2 months crizotinib). At the second interim OS analysis, superiority of alectinib to crizotinib could not be concluded (stratified HR 0.80, 99.8799 % CI: 0.35-1.82, stratified log-rank P = 0.3860; median OS not reached alectinib vs 43.7 months crizotinib). Fewer alectinib-treated patients experienced grade ≥3 adverse events (36.9 % vs 60.6 % crizotinib). CONCLUSIONS: At the final PFS analysis, alectinib continued to demonstrate superiority in IRF-assessed PFS versus crizotinib in ALK-inhibitor-naïve ALK-positive NSCLC, with a favorable safety profile. OS follow-up continues.

KW - Alectinib

KW - ALK-positive

KW - Crizotinib

KW - J-ALEX

KW - NSCLC

KW - PFS

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