touchFEATURE
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
- 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.
- 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.
- 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.
- 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.
- 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.
- SARCLISA (Isatuximab) Summary of product characteristics. Sanofi-aventis groupe: Paris, France; 2024.
- 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.
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