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Safety and tolerability of AMG 330 in adults with relapsed/refractory AML: a phase 1a dose-escalation study.
Ravandi, Farhad; Subklewe, Marion; Walter, Roland B; Vachhani, Pankit; Ossenkoppele, Gert; Buecklein, Veit; Döhner, Hartmut; Jongen-Lavrencic, Mojca; Baldus, Claudia D; Fransecky, Lars; Pardee, Timothy S; Kantarjian, Hagop; Yen, Priscilla K; Mukundan, Lata; Panwar, Bharat; Yago, Marc R; Agarwal, Suresh; Khaldoyanidi, Sophia K; Stein, Anthony.
Afiliação
  • Ravandi F; Department of Leukemia, MD Anderson Cancer Center, Houston, TX, USA.
  • Subklewe M; Department of Medicine III, University Hospital, LMU Munich, Munich, Germany.
  • Walter RB; Laboratory for Translational Research, Gene Center, LMU Munich, Munich, Germany.
  • Vachhani P; Translational Science and Therapeutics Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
  • Ossenkoppele G; Division of Hematology and Oncology, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.
  • Buecklein V; Amsterdam University Medical Center, Amsterdam, The Netherlands.
  • Döhner H; Department of Medicine III, University Hospital, LMU Munich, Munich, Germany.
  • Jongen-Lavrencic M; Laboratory for Translational Research, Gene Center, LMU Munich, Munich, Germany.
  • Baldus CD; Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.
  • Fransecky L; Department of Hematology, Erasmus University Medical Center Cancer Institute, Rotterdam, The Netherlands.
  • Pardee TS; Department of Internal Medicine II, University Hospital Schleswig-Holstein, Kiel, Germany.
  • Kantarjian H; Department of Internal Medicine II, University Hospital Schleswig-Holstein, Kiel, Germany.
  • Yen PK; Department of Internal Medicine, Section on Hematology and Oncology, Atrium Health Wake Forest Baptist, Winston-Salem, NC, USA.
  • Mukundan L; Department of Leukemia, MD Anderson Cancer Center, Houston, TX, USA.
  • Panwar B; Amgen Inc, Thousand Oaks, CA, USA.
  • Yago MR; Amgen Inc, South San Francisco, CA, USA.
  • Agarwal S; Amgen Inc, South San Francisco, CA, USA.
  • Khaldoyanidi SK; Amgen Inc, South San Francisco, CA, USA.
  • Stein A; Amgen Inc, Thousand Oaks, CA, USA.
Leuk Lymphoma ; 65(9): 1281-1291, 2024 Sep.
Article em En | MEDLINE | ID: mdl-38712673
ABSTRACT
AMG 330, a bispecific T-cell engager (BiTE®) that binds CD33 and CD3 on T cells facilitates T-cell-mediated cytotoxicity against CD33+ cells. This first-in-human, open-label, dose-escalation study evaluated the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of AMG 330 in adults with relapsed/refractory acute myeloid leukemia (R/R AML). Amongst 77 patients treated with AMG 330 (0.5 µg/day-1.6 mg/day) on 14-day or 28-day cycles, maximum tolerated dose was not reached; median duration of treatment was 29 days. The most frequent treatment-related adverse events were cytokine release syndrome (CRS; 78%) and rash (30%); 10% of patients experienced grade 3/4 CRS. CRS was mitigated with stepwise dosing of AMG 330, prophylactic dexamethasone, and early treatment with tocilizumab. Among 60 evaluable patients, eight achieved complete remission or morphologic leukemia-free state; of the 52 non-responders, 37% had ≥50% reduction in AML bone marrow blasts. AMG 330 is a promising CD33-targeted therapeutic strategy for R/R AML.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Leucemia Mieloide Aguda / Anticorpos Biespecíficos Limite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Ano de publicação: 2024 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Leucemia Mieloide Aguda / Anticorpos Biespecíficos Limite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Ano de publicação: 2024 Tipo de documento: Article