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<p>In the Phase 2 IZALCO study, we evaluated efficacy, patient preference, safety and pharmacokinetics for isatuximab administered SC by an innovative on-body injector (OBI) or manual injection, plus carfilzomib-dexamethasone (Kd) in relapsed/refractory multiple myeloma (RRMM) patients. In Part 1, isatuximab SC was injected manually (cycles 1−6). In Part 2, patients were randomized to isatuximab SC by manual injection (cycles 1−3) followed by OBI administration (cycles 4−6) or to isatuximab OBI (cycles 1−3) followed by manual injection (cycles 4−6). From cycle 7, all patients could choose either treatment method. Overall, 74 RRMM patients received isatuximab SC plus Kd: 8 in Part 1 and 66 in Part 2. The patients had a median age of 65.0 years (44−85) with a median of 1 prior treatment line (1−5). The study met its primary efficacy endpoint with a 79.7% overall response rate (<i>N</i> = 74), at a median follow-up of 10.1 months. 74.5% of patients preferred the OBI rather than manual injection, 17% preferred manual injection, 8.5% had no preference. No impact of the SC delivery method was observed on efficacy, safety, pharmacokinetics, and immunogenicity of isatuximab given SC plus Kd, supporting the feasibility of using the OBI as a convenient method for isatuximab SC administration. Clinical trial information: ClinicalTrials.gov NCT05704049.</p>

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Efficacy and safety of isatuximab subcutaneous plus carfilzomib and dexamethasone in patients with relapsed/refractory multiple myeloma: results of the Phase 2 study IZALCO

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年12月27日

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  • Gurdeep Parmar,
  • Marcelo Capra,
  • Fernanda Seguro,
  • Vania Hungria,
  • Meletios-Athanasios Dimopoulos,
  • Sosana Delimpasi,
  • Jiří Minařík,
  • Ivan Špička,
  • Luděk Pour,
  • Herlander Marques,
  • Graça Esteves,
  • Kazutaka Sunami,
  • Junichiro Yuda,
  • Roman Hájek,
  • Jana Mihályová,
  • Christine Soufflet,
  • Disa Yu,
  • Khadija Benlhassan,
  • Victorine Koch,
  • Erin Comerford,
  • Paul Cordero,
  • Florence Suzan,
  • Hang Quach

摘要

In the Phase 2 IZALCO study, we evaluated efficacy, patient preference, safety and pharmacokinetics for isatuximab administered SC by an innovative on-body injector (OBI) or manual injection, plus carfilzomib-dexamethasone (Kd) in relapsed/refractory multiple myeloma (RRMM) patients. In Part 1, isatuximab SC was injected manually (cycles 1−6). In Part 2, patients were randomized to isatuximab SC by manual injection (cycles 1−3) followed by OBI administration (cycles 4−6) or to isatuximab OBI (cycles 1−3) followed by manual injection (cycles 4−6). From cycle 7, all patients could choose either treatment method. Overall, 74 RRMM patients received isatuximab SC plus Kd: 8 in Part 1 and 66 in Part 2. The patients had a median age of 65.0 years (44−85) with a median of 1 prior treatment line (1−5). The study met its primary efficacy endpoint with a 79.7% overall response rate (N = 74), at a median follow-up of 10.1 months. 74.5% of patients preferred the OBI rather than manual injection, 17% preferred manual injection, 8.5% had no preference. No impact of the SC delivery method was observed on efficacy, safety, pharmacokinetics, and immunogenicity of isatuximab given SC plus Kd, supporting the feasibility of using the OBI as a convenient method for isatuximab SC administration. Clinical trial information: ClinicalTrials.gov NCT05704049.