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Isatuximab demonstrated consistent PFS benefits across diverse patient profiles in RRMM in 2 pivotal trials

Learning Objectives

After watching these videos, participants should be better able to:

  • Explain why isatuximab can be an appropriate and effective treatment in RRMM patients across diverse profiles such as those with lenalidomide refractoriness, high-risk cytogenetics, or renal impairment
  • Discuss key efficacy and safety findings from the pivotal phase 3 IKEMA and ICARIA-MM trials, including subgroup analyses
  • Summarise the robust design of the 2 pivotal trials
Overview

Isatuximab is a CD38-receptor–targeted monoclonal antibody approved as combination therapy for the treatment of certain patients who have received at least 1 prior line of therapy.6

In this activity, 3 short animated videos explore emerging clinical data from the pivotal, phase 3 IKEMA and ICARIA-MM trials (including subgroup analyses), which demonstrate that isatuximab can be an appropriate and effective treatment across diverse patient profiles in RRMM.1-5

PFS=progression-free survival; RRMM=relapsed and/or refractory multiple myeloma.

SARCLISA is indicated6:

  • In combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy
  • In combination with carfilzomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy

References

  1. Attal M, et al. Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study. Lancet. 2019;394(10214):2096–107.
  2. Martin T, et al. Isatuximab, carfilzomib, and dexamethasone in patients with relapsed multiple myeloma: updated results from IKEMA, a randomized Phase 3 study. Blood Cancer J. 2023;12(1):72.
  3. Harrison SJ, et al. Subgroup analysis of ICARIA-MM study in relapsed/refractory multiple myeloma patients with high-risk cytogenetics. Br J Haematol. 2021;194(1):120–31.
  4. Capra M, et al. Isatuximab plus carfilzomib and dexamethasone versus carfilzomib and dexamethasone in relapsed multiple myeloma patients with renal impairment: IKEMA subgroup analysis. Haematologica. 2022;107(6):1397–409.
  5. Dimopoulos MA, et al. Isatuximab plus pomalidomide and dexamethasone in relapsed/refractory multiple myeloma patients with renal impairment: ICARIA-MM subgroup analysis. Leukemia. 2021;35(2):562–72.
  6. SARCLISA (Isatuximab) Summary of product characteristics. Sanofi-aventis groupe: Paris, France; 2024.
  7. Moreau P, et al. Isatuximab, carfilzomib, and dexamethasone in relapsed multiple myeloma (IKEMA): a multicentre, open-label, randomised phase 3 trial. Lancet. 2021;397(10292):2361–71.

Study designs6

  • IKEMA: a randomised, open-label, phase 3 study evaluating the efficacy and safety of SARCLISA + Kd vs Kd alone in 302 patients with relapsed and/or refractory multiple myeloma who had received 1 to 3 prior lines of therapy. PFS was the primary endpoint; secondary endpoints included ORR, ≥VGPR, CR, MRD-, and OS
  • ICARIA-MM: a randomised, open-label, phase 3 study evaluating the efficacy and safety of SARCLISA + Pd vs Pd alone in 307 patients with relapsed and refractory multiple myeloma who had received at least 2 prior lines of therapy, including lenalidomide and a proteasome inhibitor. PFS was the primary endpoint; secondary endpoints included ORR and OS

CR=complete response; Kd=carfilzomib and dexamethasone; MRD-=minimal residual disease negativity; ORR=overall response rate; OS=overall survival; Pd=pomalidomide and dexamethasone; VGPR=very good partial response.

Most common adverse reactions:

  • In IKEMA, the most frequent adverse reactions (≥20%) were infusion reactions (46%), hypertension (37%), diarrhoea (36%), upper respiratory tract infection (36%), pneumonia (29%), fatigue (28%), dyspnoea (28%), insomnia (24%), bronchitis (23%), and back pain (22%)6
  • Serious adverse reactions occurred in 59% of patients receiving SARCLISA + Kd vs 57% with Kd alone6,7
  • In ICARIA-MM, the most common adverse reactions (≥20%) were neutropenia (47%), infusion reactions (38%), pneumonia (31%), upper respiratory tract infection (28%), diarrhoea (26%), and bronchitis (24%)6
  • Serious adverse reactions occurred in 62% of patients receiving SARCLISA + Pd vs 54% with Pd alone1,6

Please see the full Summary of Product Characteristics on the SARCLISA website.

Topics covered in this activity

Myeloma

Topics covered in this activity

Myeloma
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