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December 8, 2025Blood

Isatuximab subcutaneous in relapsed/refractory multiple myeloma: Exposure-response and serum m-protein dynamics analyses from phase 3 iraklia Study and the phase 1b Study

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Authors

NGNadia GaudelSanofi (France)HTHoai‐Thu ThaiInserm

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Implication

Phase 3 trial found equivalent overall response rate of isatuximab SC vs IV in relapsed multiple myeloma, suggesting safety with both regimens.

Key Points

  • To assess the exposure-response relationships of isatuximab in relapsed/refractory multiple myeloma patients.
  • Analyzed data from Phase 3 IRAKLIA and Phase 1b studies.
  • Utilized exposure-efficacy and exposure-safety analyses for treatment outcomes.
  • Applied a population pharmacokinetic model to predict exposure measures.
  • The best predictor for overall response rate was trough level after 4 weeks of treatment.
  • Both subcutaneous and intravenous isatuximab showed similar safety profiles and treatment responses.
  • Patients with lower body weight experienced reduced treatment response despite adequate exposure.

Cite This Study

Gaudel et al. (2025) studied this question.

synapsesocial.com/papers/693624d74fa91c937236d17bhttps://doi.org/10.1182/blood-2025-5826
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Isatuximab (Isa) subcutaneous (SC) via an on-body injector (OBI) vs isa intravenous (IV), plus pomalidomide and dexamethasone (Pd) in relapsed/refractory multiple myeloma (RRMM): East asia subgroup results from the randomized, non-inferiority, phase 3 iraklia study2025
  2. 2Isatuximab subcutaneous by on-body injector in Relapsed/Refractory multiple myeloma in the Phase 3 iraklia study: Effect of body weight on pharmacokinetics and clinical outcome2025
  3. 3Multicenter phase 2 study of subcutaneous isatuximab plus bortezomib , lenalidomide and dexamethasone (Isa Sc-VRd) in transplant ineligible newly diagnosed multiple myeloma: Final analysis of the isasocut study (IFM 2022-05)2025 · 1 citations
  4. 4Isatuximab with bortezomib, cyclophosphamide, and dexamethasone followed by isatuximab and lenalidomide maintenance in newly diagnosed multiple myeloma patients with severe renal impairment: Final analysis of a phase 2 study by the greek myeloma study group2025
  5. 5Isatuximab (Isa) plus lenalidomide (R), Bortezomib (V), and dexamethasone (d) (Isa-RVd) as induction therapy in transplant-eligible patients (pts) with newly diagnosed multiple myeloma (NDMM): Primary analysis of parallel phase 2 studies by the Dana-Farber Cancer Institute (DFCI) and Cancer Trials Ireland (CTI)2025