Mogamulizumab for relapsed adult T-cell leukemia–lymphoma

Updated follow-up analysis of phase I and II studies

Takashi Ishida, Atae Utsunomiya, Tatsuro Jo, Kazuhito Yamamoto, Koji Kato, Shinichiro Yoshida, Shigeki Takemoto, Hitoshi Suzushima, Yukio Kobayashi, Yoshitaka Imaizumi, Kenichi Yoshimura, Kouichi Kawamura, Takeshi Takahashi, Kensei Tobinai, Ryuzo Ueda

Research output: Contribution to journalArticle

18 Citations (Scopus)

Abstract

The present study sought to elucidate the prognosis of adult T-cell leukemia–lymphoma (ATL) patients receiving mogamulizumab, a defucosylated anti-CCR4 monoclonal antibody. Progression-free survival (PFS) and overall survival (OS) of ATL patients enrolled in two studies are herein updated, namely NCT00355472 (phase I study of mogamulizumab in relapsed patients with ATL and peripheral T-cell lymphoma) and NCT00920790 (phase II study for relapsed ATL). Of 13 patients with relapsed aggressive ATL in the phase I study, four (31%) survived >3 years. For 26 relapsed patients with aggressive ATL in the phase II study, median PFS was 5.2 months and 1-year PFS was 26%, whereas median OS was 14.4 months, and 3-year OS was 23%. For patients without a rash or who developed a grade 1 rash only, median PFS was 0.8 months, and 1-year PFS was zero, with a median OS of 6.0 months, and 3-year OS of 8%. In contrast, for patients who developed a rash ≥grade 2, median PFS was 11.7 months, and 1-year PFS was 50%, with a median OS of 25.6 months, and 3-year OS of 36%. Thus, we conclude that mogamulizumab monotherapy may improve PFS and OS in some patients with relapsed aggressive ATL, especially those who develop a skin rash as a moderate immune-related adverse event. Therefore, further investigation is warranted to validate the present observations and to clarify the mechanisms involved in the activity of mogamulizumab.

Original languageEnglish
Pages (from-to)2022-2029
Number of pages8
JournalCancer Science
Volume108
Issue number10
DOIs
Publication statusPublished - Oct 1 2017

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Disease-Free Survival
T-Lymphocytes
Survival
Exanthema
Peripheral T-Cell Lymphoma
mogamulizumab
Monoclonal Antibodies

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Mogamulizumab for relapsed adult T-cell leukemia–lymphoma : Updated follow-up analysis of phase I and II studies. / Ishida, Takashi; Utsunomiya, Atae; Jo, Tatsuro; Yamamoto, Kazuhito; Kato, Koji; Yoshida, Shinichiro; Takemoto, Shigeki; Suzushima, Hitoshi; Kobayashi, Yukio; Imaizumi, Yoshitaka; Yoshimura, Kenichi; Kawamura, Kouichi; Takahashi, Takeshi; Tobinai, Kensei; Ueda, Ryuzo.

In: Cancer Science, Vol. 108, No. 10, 01.10.2017, p. 2022-2029.

Research output: Contribution to journalArticle

Ishida, T, Utsunomiya, A, Jo, T, Yamamoto, K, Kato, K, Yoshida, S, Takemoto, S, Suzushima, H, Kobayashi, Y, Imaizumi, Y, Yoshimura, K, Kawamura, K, Takahashi, T, Tobinai, K & Ueda, R 2017, 'Mogamulizumab for relapsed adult T-cell leukemia–lymphoma: Updated follow-up analysis of phase I and II studies', Cancer Science, vol. 108, no. 10, pp. 2022-2029. https://doi.org/10.1111/cas.13343
Ishida, Takashi ; Utsunomiya, Atae ; Jo, Tatsuro ; Yamamoto, Kazuhito ; Kato, Koji ; Yoshida, Shinichiro ; Takemoto, Shigeki ; Suzushima, Hitoshi ; Kobayashi, Yukio ; Imaizumi, Yoshitaka ; Yoshimura, Kenichi ; Kawamura, Kouichi ; Takahashi, Takeshi ; Tobinai, Kensei ; Ueda, Ryuzo. / Mogamulizumab for relapsed adult T-cell leukemia–lymphoma : Updated follow-up analysis of phase I and II studies. In: Cancer Science. 2017 ; Vol. 108, No. 10. pp. 2022-2029.
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abstract = "The present study sought to elucidate the prognosis of adult T-cell leukemia–lymphoma (ATL) patients receiving mogamulizumab, a defucosylated anti-CCR4 monoclonal antibody. Progression-free survival (PFS) and overall survival (OS) of ATL patients enrolled in two studies are herein updated, namely NCT00355472 (phase I study of mogamulizumab in relapsed patients with ATL and peripheral T-cell lymphoma) and NCT00920790 (phase II study for relapsed ATL). Of 13 patients with relapsed aggressive ATL in the phase I study, four (31{\%}) survived >3 years. For 26 relapsed patients with aggressive ATL in the phase II study, median PFS was 5.2 months and 1-year PFS was 26{\%}, whereas median OS was 14.4 months, and 3-year OS was 23{\%}. For patients without a rash or who developed a grade 1 rash only, median PFS was 0.8 months, and 1-year PFS was zero, with a median OS of 6.0 months, and 3-year OS of 8{\%}. In contrast, for patients who developed a rash ≥grade 2, median PFS was 11.7 months, and 1-year PFS was 50{\%}, with a median OS of 25.6 months, and 3-year OS of 36{\%}. Thus, we conclude that mogamulizumab monotherapy may improve PFS and OS in some patients with relapsed aggressive ATL, especially those who develop a skin rash as a moderate immune-related adverse event. Therefore, further investigation is warranted to validate the present observations and to clarify the mechanisms involved in the activity of mogamulizumab.",
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AU - Ishida, Takashi

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AU - Jo, Tatsuro

AU - Yamamoto, Kazuhito

AU - Kato, Koji

AU - Yoshida, Shinichiro

AU - Takemoto, Shigeki

AU - Suzushima, Hitoshi

AU - Kobayashi, Yukio

AU - Imaizumi, Yoshitaka

AU - Yoshimura, Kenichi

AU - Kawamura, Kouichi

AU - Takahashi, Takeshi

AU - Tobinai, Kensei

AU - Ueda, Ryuzo

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N2 - The present study sought to elucidate the prognosis of adult T-cell leukemia–lymphoma (ATL) patients receiving mogamulizumab, a defucosylated anti-CCR4 monoclonal antibody. Progression-free survival (PFS) and overall survival (OS) of ATL patients enrolled in two studies are herein updated, namely NCT00355472 (phase I study of mogamulizumab in relapsed patients with ATL and peripheral T-cell lymphoma) and NCT00920790 (phase II study for relapsed ATL). Of 13 patients with relapsed aggressive ATL in the phase I study, four (31%) survived >3 years. For 26 relapsed patients with aggressive ATL in the phase II study, median PFS was 5.2 months and 1-year PFS was 26%, whereas median OS was 14.4 months, and 3-year OS was 23%. For patients without a rash or who developed a grade 1 rash only, median PFS was 0.8 months, and 1-year PFS was zero, with a median OS of 6.0 months, and 3-year OS of 8%. In contrast, for patients who developed a rash ≥grade 2, median PFS was 11.7 months, and 1-year PFS was 50%, with a median OS of 25.6 months, and 3-year OS of 36%. Thus, we conclude that mogamulizumab monotherapy may improve PFS and OS in some patients with relapsed aggressive ATL, especially those who develop a skin rash as a moderate immune-related adverse event. Therefore, further investigation is warranted to validate the present observations and to clarify the mechanisms involved in the activity of mogamulizumab.

AB - The present study sought to elucidate the prognosis of adult T-cell leukemia–lymphoma (ATL) patients receiving mogamulizumab, a defucosylated anti-CCR4 monoclonal antibody. Progression-free survival (PFS) and overall survival (OS) of ATL patients enrolled in two studies are herein updated, namely NCT00355472 (phase I study of mogamulizumab in relapsed patients with ATL and peripheral T-cell lymphoma) and NCT00920790 (phase II study for relapsed ATL). Of 13 patients with relapsed aggressive ATL in the phase I study, four (31%) survived >3 years. For 26 relapsed patients with aggressive ATL in the phase II study, median PFS was 5.2 months and 1-year PFS was 26%, whereas median OS was 14.4 months, and 3-year OS was 23%. For patients without a rash or who developed a grade 1 rash only, median PFS was 0.8 months, and 1-year PFS was zero, with a median OS of 6.0 months, and 3-year OS of 8%. In contrast, for patients who developed a rash ≥grade 2, median PFS was 11.7 months, and 1-year PFS was 50%, with a median OS of 25.6 months, and 3-year OS of 36%. Thus, we conclude that mogamulizumab monotherapy may improve PFS and OS in some patients with relapsed aggressive ATL, especially those who develop a skin rash as a moderate immune-related adverse event. Therefore, further investigation is warranted to validate the present observations and to clarify the mechanisms involved in the activity of mogamulizumab.

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