Mogamulizumab for relapsed adult T-cell leukemia-lymphoma: Updated follow-up analysis of phase I and II studies.
Takashi IshidaAtae UtsunomiyaTatsuro JoKazuhito YamamotoKoji KatoShinichiro YoshidaShigeki TakemotoHitoshi SuzushimaYukio KobayashiYoshitaka ImaizumiKenichi YoshimuraKouichi KawamuraTakeshi TakahashiKensei TobinaiRyuzo UedaPublished in: Cancer science (2017)
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.
Keyphrases
- acute myeloid leukemia
- diffuse large b cell lymphoma
- acute lymphoblastic leukemia
- phase ii study
- multiple myeloma
- hodgkin lymphoma
- end stage renal disease
- free survival
- newly diagnosed
- ejection fraction
- monoclonal antibody
- prognostic factors
- bone marrow
- magnetic resonance imaging
- emergency department
- randomized controlled trial
- radiation therapy
- young adults
- computed tomography
- immune response
- case control