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Newest Findings

Presentation From the 66th American Society of Hematology (ASH) Annual Meeting & Exposition 2025

IONA-MM Second Interim Analysis

Real-World Experience with Isatuximab in Patients with Relapsed and/or Refractory Multiple Myeloma (RRMM)

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Recently published data: Richardson PG et al. Haematologica. 2025.

ICARIA-MM Final Overall Survival Analysis

SARCLISA + Pd demonstrated a clinically meaningful OS benefit vs Pd

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The addition of SARCLISA to Pd improved mOS by 6.9 months at a median follow-up of ~52 months

The addition of SARCLISA to Pd improved mOS by 6.9 months at a median follow-up of ~52 months

aOne-sided P value. Significance level is set to 0.02.

Adapted from Richardson PG et al. Haematologica. 2025. doi:10.3324/haematol.2023.284325

  • SARCLISA + Pd improved median time to next treatment at 15.5 months (95% CI: 12.1, 19.8) vs Pd at 8.9 months (95% CI: 6.3, 11.5), HR=0.548 (95% CI: 0.417, 0.718)
  • The addition of SARCLISA to Pd increased Grade ≥3 TEAE rates (91%) and serious TEAE rates (74%) vs Pd (76% and 61%, respectively) but did not increase fatal events or events leading to treatment discontinuation. No new safety concerns were identified with longer follow-up

HR=hazard ratio; mOS=median overall survival; OS=overall survival; Pd=pomalidomide and dexamethasone; TEAE=treatment-emergent adverse event.

Reference: Richardson PG, Perrot A, Miguel JS, et al. Isatuximab-pomalidomide-dexamethasone versus pomalidomide-dexamethasone in patients with relapsed and refractory multiple myeloma: final overall survival analysis. Haematologica. 2025. doi:10.3324/haematol.2023.284325

For more information about the phase 3 ICARIA-MM study, view SARCLISA + Pd Trial Design.

Presentations From the 20th International Myeloma Society (IMS) 2023 Annual Meeting and Exposition

IKEMA Final Overall Survival Analysis

SARCLISA + Kd demonstrated a clinically meaningful OS benefit vs Kd at a median follow-up of 56.6 months

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*138 OS events: 79 (44.1%) in SARCLISA + Kd; 59 (48.0%) in Kd (cutoff date for OS analysis February 7, 2023). Results of a sensitivity analysis showed that COVID-19 disproportionately impacted OS in the SARCLISA + Kd arm; HR=0.803 (95% CI: 0.564, 1.142).

†Nominal one-sided P value.

Adapted from Yong K et al. Presented at: 20th International Myeloma Society (IMS) Annual Meeting and Exposition; September 27-30, 2023; Athens, Greece. ID #OA-48.

  • Safety summary at the OS analysis (median follow-up of 56.6 months):
    • Grade ≥3 TEAEs and serious TEAEs occurred in 84.2% and 73.0%, and 71.2% and 60.7% of patients in the SARCLISA + Kd and Kd arms, respectively
    • TEAEs leading to discontinuation occurred in 13.6% and 18.0% of patients in the SARCLISA + Kd and Kd arms, respectively
    • Despite an additional 30 weeks of treatment exposure in the SARCLISA + Kd arm, the incidence of cardiac failure (grouping using MedDRA SMQ cardiac failure narrow terms) was similar in both arms: 8.5% (4.5% Grade ≥3) and 8.2% (4.1% Grade ≥3) in the SARCLISA + Kd and Kd arms, respectively

HR=hazard ratio; Kd=carfilzomib and dexamethasone; MedDRA=Medical Dictionary for Regulatory Activities; mOS=median overall survival; mPFS2=median second progression-free survival; mTTNT=median time to next treatment; NR=not reached; OS=overall survival; PFS2=second progression-free survival; SMQ=Standardised MedDRA Queries; TEAE=treatment-emergent adverse event.

Reference: Yong K, Martin T, Dimopoulos MA, et al. Isatuximab plus carfilzomib and dexamethasone versus carfilzomib and dexamethasone in patients with relapsed multiple myeloma (IKEMA): overall survival analysis. Presented at: 20th International Myeloma Society (IMS) Annual Meeting and Exposition; September 27-30, 2023; Athens, Greece. ID #OA-48.

For more information about the phase 3 IKEMA study, view SARCLISA + Kd Trial Design.

IMAGE Subgroup Analysis: SARCLISA + Pd in Patients With RRMM in Real-Life Context in France

SARCLISA + Pd showed a PFS benefit in subgroups of interest

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Median PFS in elderly patients (age ≥75 years) was similar to that seen in patients age <75 years

Median PFS in elderly patients (age ≥75 years) was similar to that seen in patients age <75 years

Adapted from Decaux O et al. Presented at: 20th International Myeloma Society (IMS) Annual Meeting and Exposition; September 27-30, 2023; Athens, Greece. Poster 287.

  • Results are from the noninterventional, retrospective IMAGE study conducted in France. In the overall study population (N=294):
    • Patients had received a median of 2 prior lines of therapy (range 1-9)
    • 73% of patients were refractory to lenalidomide
    • Median PFS was 12.4 months, with a median follow-up of 14.2 months
  • Subgroups of interest included elderly patients (age ≥75 years; n=83), patients with severe renal impairment (eGFR <30 mL/min/1.73 m2; n=25), and patients with high-risk cytogenetics (presence of del[17p], t[4;14], or t[14;16]; n=40)
    • Median PFS was 10.0 months in patients with eGFR <30 mL/min/1.73 m2 (95% CI: 2.4, 18.6) and 13.2 months in patients with eGFR ≥30 mL/min/1.73 m2 (95% CI: 9.0, 16.6)
    • Median PFS was 7.6 months (95% CI: 2.8, NR) in patients with high-risk cytogenetics (n=40), 10.2 months (95% CI: 7.8, 14.2) in patients with standard-risk cytogenetics (n=134), and 15.0 months (95% CI: 11.2, 19.8) in patients whose cytogenetic risk was unknown (n=120)
    • The data reported in the noninterventional IMAGE study are consistent with the benefit observed in the pivotal ICARIA-MM study
  • Safety summary (N=299):
    • 3 elderly patients and 1 patient with high-risk cytogenetics had an AE leading to permanent discontinuation of SARCLISA
    • Incidence of neutropenia in elderly patients, patients with severe renal impairment, and patients with high-risk cytogenetics was 12.0%, 0%, and 7.5%, respectively
    • Infections and infestations occurred in 3 patients in the overall safety population: 2 who were elderly, 1 with severe renal impairment, and 0 with high-risk cytogenetics

AE=adverse event; eGFR=estimated glomerular filtration rate; mPFS=median progression-free survival; NR=not reached; Pd=pomalidomide and dexamethasone; PFS=progression-free survival; RRMM=relapsed and/or refractory multiple myeloma.

Reference: Decaux O, Fontan J, Perrot A, et al. Isatuximab plus pomalidomide and dexamethasone in patients with relapsed and/or refractory multiple myeloma in real-life context in France: IMAGE subgroup analysis based on subgroups of interest. Presented at: 20th International Myeloma Society (IMS) Annual Meeting and Exposition; September 27-30, 2023; Athens, Greece. Poster 287.

For more information about the phase 3 ICARIA-MM study, view SARCLISA + Pd Trial Design.

Presentations From the European Hematology Association (EHA) 2023 Hybrid Congress

SARCLISA in Relapsed Multiple Myeloma Patients With Ultra-High-Risk Cytogenetics

The addition of SARCLISA to Kd and Pd led to a PFS benefit regardless of risk category

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PFS in IKEMA for patients with (A) standard risk, (B) extended high-risk, and (C) ultra-high-risk MM

PFS in ICARIA-MM for patients with (A) standard risk, (B) extended high-risk, and (C) ultra-high-risk MM

Adapted from Moreau P, et al. Presented at: European Hematology Association (EHA) 2023 Hybrid Congress; June 8-11, 2023; Frankfurt, Germany, and online.

  • Extended high-risk was defined as the presence of one of the following: del(17p), t(4;14), t(14;16), or 1q21+, which includes both gain(1q21) and amp(1q21)
  • Ultra-high-risk was defined as the presence of ≥2 of the following: del(17p), t(4;14), t(14;16), or 1q21+
  • The incidence of grade ≥3 TEAEs was generally higher in the SARCLISA-containing arm than in the control arm in both trials, regardless of risk category, with the exception of standard-risk patients in IKEMA
  • This information is from a post hoc analysis of the IKEMA and ICARIA-MM trials.

HR=hazard ratio; Kd=carfilzomib and dexamethasone; MM=multiple myeloma; mPFS=median progression-free survival; NR=not reached; Pd=pomalidomide and dexamethasone; PFS=progression-free survival; TEAE=treatment-emergent adverse event.

Reference: Moreau P, Perrot A, Dimopolous MA, et al. Isatuximab in relapsed multiple myeloma patients with ultra-high-risk cytogenetics: ICARIA-MM and IKEMA subgroup analysis. Presented at: European Hematology Association (EHA) 2023 Hybrid Congress; June 8-11, 2023; Frankfurt, Germany, and online. Poster P931.

For more information about the phase 3 SARCLISA studies, view SARCLISA + Kd Trial Design and SARCLISA + Pd Trial Design.

Long-Term Outcomes With SARCLISA + Kd in Relapsed Multiple Myeloma Patients With 1q21+ Status: Updated Results From the Phase 3 IKEMA Study

The addition of SARCLISA to Kd resulted in longer PFS compared to Kd in patients with 1q21+ chromosomal abnormalities

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PFS in IKEMA in patients (A) without 1q21+, (B) with 1q21+, (C) with isolated 1q21+, (D) with gain(1q21), (E) with amp(1q21)

Adapted from Facon T, et al. Presented at: European Hematology Association (EHA) 2023

Hybrid Congress; June 8-11, 2023; Frankfurt, Germany, and online.

  • The presence of 1q21+ chromosomal abnormalities (gain or amplification) is associated with a higher risk of progression and worse prognosis in patients with MM
  • In this updated subgroup analysis, PFS and depth of response was evaluated in relapsed MM patients with 1q21+ status. In the SARCLISA + Kd and Kd arms, respectively:
    • 41.9% and 42.3% of patients had 1q21+ (≥3 copies, with or without HRCA)
    • 26.3% and 25.2% of patients had isolated 1q21+ (≥3 copies, without HRCA)
    • 24.0% and 30.1% of patients had gain(1q21) (3 copies, with or without HRCA)
    • 17.9% and 12.2% of patients had amp(1q21) (≥4 copies, with or without HRCA)
  • Treatment discontinuation rates due to adverse events were 10.7% and 13.1% in the SARCLISA + Kd arm vs 11.5% and 23.6% for the Kd arm in patients with 1q21+ and without 1q21+, respectively

HRCA=high-risk chromosomal abnormalities; Kd=carfilzomib and dexamethasone; MM=multiple myeloma; mPFS=median progression-free survival; NC=not calculable; PFS=progression-free survival.

Reference: Facon T, Moreau P, Spicka I, et al. Long-term outcomes with isatuximab-carfilzomib-dexamethasone (Isa-Kd) in relapsed multiple myeloma patients with 1q21+ status: updated results from the phase 3 IKEMA study. Presented at: European Hematology Association (EHA) 2023 Hybrid Congress; June 8-11, 2023; Frankfurt, Germany, and online. Poster P916.

For more information about the phase 3 SARCLISA studies, view SARCLISA + Kd Trial Design.

Allocation and Validation of the Second Revision of the International Staging System (R2-ISS) in the IKEMA and ICARIA-MM Studies

A study validating the R2-ISS in patients with RRMM and in patients treated with an anti-CD38 mAb

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PFS by R2-ISS stage (pooled data from IKEMA and ICARIA-MM)

PFS by R2-ISS stage (pooled data from IKEMA and ICARIA-MM).

Adapted from Perrot A, et al. Presented at: European Hematology Association (EHA) 2023 Hybrid Congress; June 8-11, 2023; Frankfurt, Germany, and online.

  • Pooled patients from both arms of IKEMA and ICARIA-MM were re-allocated into R2-ISS stage using the scoring strategy outlined by D’Agostino et al
  • In this pooled analysis, SARCLISA triplet therapies (in combination with Kd and Pd) led to longer PFS vs comparator doublets regardless of R2-ISS stage
  • In this study, PFS decreased with increasing R2-ISS stage, consistent with published findings
  • In the IKEMA and ICARIA-MM trials (N=609), 68 patients were R2-ISS Stage I, 136 patients were Stage II, 204 patients were Stage III, 55 patients were Stage IV, and 146 patients were unclassified

Kd=carfilzomib and dexamethasone; mAb=monoclonal antibody; NC=not calculable; Pd=pomalidomide and dexamethasone;

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

Reference: Perrot A, Richardson P, Mikhael J, et al. Allocation and validation of the second revision of the International Staging System in the ICARIA-MM and IKEMA studies. Presented at: European Hematology Association (EHA) 2023 Hybrid Congress; June 8-11, 2023; Frankfurt, Germany, and online. Poster P968.

For more information about the phase 3 SARCLISA studies, view SARCLISA + Kd Trial Design and SARCLISA + Pd Trial Design.

Prior Findings

Presentations From the 64th American Society of Hematology (ASH) Annual Meeting & Exposition (2022)

IKEMA Post Hoc Subgroup Analysis by Number of Prior Lines of Therapy

SARCLISA + Kd improved PFS and depth of response in patients with RRMM, regardless of the number of prior lines of therapy

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mPFS: patients with only 1 prior line of therapy

Adapted from Capra et al. Presented at: 64th American Society of Hematology (ASH) Annual Meeting & Exposition; December 10-13, 2022; New Orleans, LA. Poster 3176.

  • In patients who received 1 prior line of therapy, mPFS was 38.2 months with SARCLISA + Kd and 28.2 months with Kd (HR=0.723; 95.4% CI: 0.442, 1.184)
  • In patients who received >1 prior line of therapy, mPFS was 29.2 months with SARCLISA + Kd and 17.0 months with Kd (HR=0.452; 95.4% CI: 0.298, 0.686)
  • In this study, PFS decreased with increasing R2-ISS stage, consistent with published findings
  • The frequency of Grade ≥3 TEAEs were: 83.3% (SARCLISA + Kd) and 72.2% (Kd), 1 prior line; 83.8% (SARCLISA + Kd) and 73.5% (Kd), >1 prior line. Serious TEAEs occurred in 66.7% vs 51.9% of patients (1 prior line subgroup) and 72.7% vs 66.2% of patients (>1 prior line subgroup) with SARCLISA + Kd vs Kd, respectively

HR=hazard ratio; Kd=carfilzomib and dexamethasone; mPFS=median progression-free survival; NC=not calculable;

PFS=progression-free survival; R2-ISS=Second Revision of the International Staging System; RRMM=relapsed and/or refractory multiple myeloma; TEAE=treatment-emergent adverse event.

Reference: Capra M, Martin T, Moreau P, et al. Isatuximab plus carfilzomib and dexamethasone in relapsed multiple myeloma: IKEMA subgroup analysis by number of prior lines of treatment. Presented at: 64th American Society of Hematology (ASH) Annual Meeting & Exposition; December 10-13, 2022; New Orleans, LA. Poster 3176.

For more information about the phase 3 IKEMA study, view SARCLISA + Kd Trial Design.

IKEMA Subgroup Analysis: Early vs Late Relapse

This analysis examined the efficacy and safety of SARCLISA + Kd vs Kd in patients who experienced early vs late relapse from prior treatment

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  • This is a post hoc analysis with a median follow-up of 44 months; this analysis examined PFS, ORR, ≥VGPR, CR, MRD-, and OS
    • Early relapse was defined as <12 months since initiation of the most recent line of treatment in patients with ≥2 prior lines of treatment, <18 months in patients with 1 prior line of treatment, and <12 months in patients with ASCT
    • Late relapse was defined as ≥12 months since initiation of the most recent line of treatment in patients with ≥2 prior lines of treatment and ≥18 months in patients with 1 prior line of treatment
  • See the results by downloading the congress presentation below

ASCT=autologous stem cell transplant; CR=complete response; Kd=carfilzomib and dexamethasone; MRD-=minimal residual disease negative/negativity; ORR=overall response rate; OS=overall survival; PFS=progression-free survival; VGPR=very good partial response.

Reference: Facon T, Moreau P, Baker R, et al. Isatuximab plus carfilzomib and dexamethasone in pts with early versus late relapsed multiple myeloma: Ikema subgroup analysis. Presented at: 64th American Society of Hematology (ASH) Annual Meeting & Exposition; December 10-13, 2022; New Orleans, LA. Presentation 753.

For more information about the phase 3 IKEMA study, view SARCLISA + Kd Trial Design.

Presentations from International Myeloma Society (IMS) 2022

IKEMA Updated PFS Analysis

At a median follow-up of 44 months, SARCLISA + Kd demonstrated unprecedented mPFS of 3 years in a pivotal trial that includes lenalidomide-refractory patients

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IKEMA Updated PFS Analysis. At a median follow-up of 44 months, SARCLISA + Kd demonstrated unprecedented mPFS of 3 years in a pivotal trial that includes lenalidomide-refractory patients.

Adapted from Yong et al. Presented at: International Myeloma Society (IMS) Annual Meeting; August 25-27, 2022; Los Angeles, CA. Poster 284.

  • At a median follow-up of 44 months, SARCLISA + Kd demonstrated deep responses: 44% CR and 34% MRD- (vs 29% and 15% with Kd, respectively)
  • Safety profiles in both arms remained consistent with prior IKEMA findings; serious TEAEs were reported in 70% of patients on SARCLISA + Kd vs 60% on Kd
  • The most common, non-haematologic TEAEs in the SARCLISA + Kd arm were: infusion reaction (46%), diarrhoea (40%), hypertension (38%), and upper respiratory tract infection (37%)

CR=complete response; HR=hazard ratio; Kd=carfilzomib and dexamethasone; mPFS=median progression-free survival; MRD-=minimal residual disease negative/negativity; PFS=progression-free survival; TEAE=treatment-emergent adverse event.

Reference: Yong K, Moreau P, Dimopoulos MA, et al. Updated progression-free survival and depth of response in IKEMA, a randomized phase 3 trial of isatuximab, carfilzomib and dexamethasone (Isa-Kd) vs Kd in relapsed multiple myeloma. Presented at: International Myeloma Society (IMS) Annual Meeting; August 25-27, 2022; Los Angeles, CA. Poster 284.

For more information about the phase 3 IKEMA study, view SARCLISA + Kd Trial Design.

IKEMA Updated Depth of Response Analysis

At a median follow-up of 44 months, SARCLISA + Kd demonstrated deep responses

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*Stratified on randomisation factors according to IRT.

Adapted from Hajek et al. Presented at: International Myeloma Society (IMS) Annual Meeting; August 25-27, 2022; Los Angeles, CA. Presentation OAB-046.

  • SARCLISA + Kd patients had a >2-fold higher likelihood of achieving MRD- compared to Kd patients
  • The impact of achieving MRD- on long-term outcomes with SARCLISA + Kd vs Kd is discussed in the poster. MRD- rates seen in difficult-to-treat populations are also reported
  • Grade ≥3 and serious TEAEs were higher in the SARCLISA + Kd arm, regardless of MRD status (85% MRD-, 83% MRD+) vs Kd (74% MRD-, 73% MRD+); however, the addition of SARCLISA to Kd did not increase fatal TEAEs or events leading to treatment discontinuation

CR=complete response; IRC=independent response committee; IRT=interactive response technology; Kd=carfilzomib and dexamethasone; MRD=minimal residual disease; MRD-=minimal residual disease negative/negativity; MRD+=minimal residual disease positive/positivity; NGS=next-generation sequencing; ORR=overall response rate; TEAE=treatment-emergent adverse event; VGPR=very good partial response.

Reference: Hajek R, Moreau P, Augustson B, et al. Depth of response of isatuximab plus carfilzomib and dexamethasone in relapsed multiple myeloma: IKEMA updated analysis. Presented at: International Myeloma Society (IMS) Annual Meeting; August 25-27, 2022; Los Angeles, CA. Presentation OAB-046.

For more information about the phase 3 IKEMA study, view SARCLISA + Kd Trial Design.

ICARIA-MM Final Overall Survival Analysis

SARCLISA + Pd showed a clinically meaningful overall survival benefit, with a ~7-month median overall survival improvement vs Pd

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SARCLISA + Pd showed a clinically meaningful overall survival benefit, with a ~7-month median overall survival improvement vs Pd

ICARIA-MM Final Overall Survival Analysis. SARCLISA + Pd showed a clinically meaningful overall survival benefit, with an ~7-month median overall survival improvement vs Pd.

*One-sided P value, significance level is set to 0.02.

220 OS events: 106 (68.8%) in SARCLISA + Pd; 114 (74.5%) in Pd.

Adapted from Richardson et al. Presented at: International Myeloma Society (IMS) Annual Meeting; August 25-27, 2022; Los Angeles, CA. Presentation OAB-052.

  • SARCLISA + Pd improved median time to next treatment at 15.51 months (95% CI: 12.123, 19.811) vs Pd at 8.87 months (95% CI: 6.341­, 11.466), HR=0.548 (95% CI: 0.417, 0.718)
  • The addition of SARCLISA to Pd increased Grade ≥3 TEAE rates (91%) and serious TEAE rates (74%) vs Pd (76% and 61% respectively), but did not increase fatal events or events leading to treatment discontinuation

HR=hazard ratio; mOS=median overall survival; mPFS=median progression-free survival; OS=overall survival; Pd=pomalidomide and dexamethasone; TEAE=treatment-emergent adverse event.

Reference: Richardson P, Perrot R, San-Miguel J, et al. Isatuximab plus pomalidomide/low-dose dexamethasone versus pomalidomide/low-dose dexamethasone in patients with relapsed/refractory multiple myeloma (ICARIA-MM): final overall survival analysis. Presented at: International Myeloma Society (IMS) Annual Meeting; August 25-27, 2022; Los Angeles, CA. Presentation OAB-052.

For more information about the phase 3 ICARIA-MM study, view SARCLISA + Pd Trial Design.

IKEMA TRIAL DESIGN

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Sanofi does not recommend the use of its products in any manner inconsistent with that described in the label available in your country. Please refer to your local product labelling information before prescribing. View your country-specific product labelling information here.

SARCLISA® (isatuximab) – Abbreviated Prescribing Information

Name and Presentation: SARCLISA 20 mg/mL concentrate for solution for infusion. Each vial contains 100 mg of isatuximab in 5 mL of concentrate (100 mg/5 mL) or 500 mg of isatuximab in 25 mL of concentrate (500 mg/25 mL). Isatuximab is an immunoglobulin G1 (IgG1) monoclonal antibody (mAb).

Therapeutic indications: In combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor (PI) 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. In combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.

Pediatric population: Outside its authorised indications, SARCLISA has been studied in children aged 28 days to less than 18 years of age with relapsed or refractory acute lymphoblastic or myeloid leukaemia but efficacy has not been established.

Dosage and administration: SARCLISA should be administered by a healthcare professional, in an environment where resuscitation facilities are available. Premedication should be used 15-60 minutes prior to SARCLISA infusion with the following medicinal products to reduce the risk and severity of infusion reactions: Dexamethasone 40 mg (when administered in combination with isatuximab and pomalidomide) or 20 mg (when administered in combination with isatuximab and carfilzomib; or when administered in combination with isatuximab, bortezomib, and lenalidomide) oral or intravenous, 20 mg for patients ≥75 years of age, Acetaminophen, Diphenhydramine, H2 antagonists. The recommended dose of SARCLISA is 10 mg/kg body weight administered as an intravenous infusion in combination with pomalidomide and dexamethasone or in combination with carfilzomib and dexamethasone or in combination with bortezomib, lenalidomide, and dexamethasone (isatuximab regimen). Dosing schedule in combination with pomalidomide and dexamethasone or in combination with carfilzomib and dexamethasone: cycle 1: days 1, 8, 15 and 22 (weekly), cycle 2 and beyond: days 1, 15 (every 2 weeks). Each treatment cycle consists of a 28-day period. Dosing schedule in combination with bortezomib, lenalidomide, and dexamethasone: cycle 1: days 1, 8, 15, 22 and 29, cycles 2 to 4: days 1, 15 and 29 (every 2 weeks), cycles 5 to 17: days 1 and 15 (every 2 weeks), cycles 18 and beyond: day 1 (every 4 weeks). Each treatment cycle consists of a 42-day period from cycle 1 to 4, and of a 28-day period from cycle 5. Treatment is repeated until disease progression or unacceptable toxicity.

Method of administration: SARCLISA is for intravenous use. For details on preparation and infusion rate see full SmPC.

Contraindications: Hypersensitivity to the active substance or to any of the excipients. See full SmPC for full list of excipients.

Warnings and precautions: Infusion reactions, mostly mild or moderate, were observed in 38.2% of patients treated with SARCLISA in ICARIA, and in 45.8% in IKEMA but resolved on the same day in 98% of infusions, and in 24.0% of patients treated with Isa-VRd in IMROZ and resolved the same day in 97.3% of patients. The most common symptoms of an IR included dyspnoea and chills. The most common severe sign and symptom was hypertension. Vital signs should be frequently monitored during the entire infusion and when required infusion should be interrupted or permanently discontinued in case symptoms that do not improve to grade ≤1 after infusion interruption. Serious infusion reactions including severe anaphylactic reactions have also been observed after SARCLISA administration. Most of the grade 3-4 neutropenia was reported as laboratory abnormalities. In patients treated with Isa-VRd, neutropenia was reported as a laboratory abnormality in 87.5% of patients and as an adverse reaction in 30% of patients. Neutropenic complications have been observed in 1/3 of patients treated with SARCLISA. A higher incidence of infections including grade ≥3 infections occurred with SARCLISA. Antibacterial and antiviral prophylaxis (such as herpes zoster prophylaxis) according to treatment guidelines should be considered during treatment. Patients receiving SARCLISA should be closely monitored for signs of infection. Physicians should carefully evaluate patients before and during treatment as per International Myeloma Working Group (IMWG) guidelines for occurrence of secondary primary malignancies (SPM) and treatment should be initiated as indicated. Patients should be monitored closely, and appropriate precautions taken for tumor lysis syndrome. Isatuximab binds to CD38 on red blood cells (RBCs) and may result in a false positive indirect antiglobulin test (indirect Coombs test). This interference with the indirect Coombs test may persist for at least 6 months after the last infusion of SARCLISA. Patient should have blood type and screen tests performed prior to the first infusion of Isatuximab and should be monitored for theoretical risk of haemolysis. For details in tests interference see full SmPC.

Drug interactions: Isatuximab has no impact on the pharmacokinetics of pomalidomide or carfilzomib, or bortezomib, or lenalidomide and vice versa. Isatuximab may interfere with serological testing and with Serum Protein Electrophoresis and Immunofixation assays. In patients with persistent very good partial response, where isatuximab interference is suspected, consider using a validated isatuximab-specific IFE assay to distinguish isatuximab from any remaining endogenous M protein in the patient’s, to facilitate determination of complete response.

Fertility, pregnancy and lactation: Women of childbearing potential treated with isatuximab should use effective contraception during treatment and for 5 months after cessation of treatment. The use of isatuximab in pregnant women is not recommended since there are no available data.

Undesirable effects: Observed in patients treated with isatuximab in combination with pomalidomide and dexamethasone: Infections/infestations: very common: pneumonia, upper respiratory tract infection, bronchitis: common: Herpes zoster. Neoplasms benign, malignant and unspecified: common: skin cancer, solid tumour (non-skin cancer): uncommon: haematology malignancy. Blood/lymphatic system disorders: very common: neutropenia, thrombocytopenia, common: febrile neutropenia, anaemia, unknown frequency: lymphopenia. Metabolism and nutrition disorders: very common: decreased appetite. Cardiac disorders: common: atrial fibrillation. Respiratory, thoracic and mediastinal disorders: very common: dyspnoea. Gastrointestinal disorders: very common: diarrhoea, nausea, vomiting. Investigations: common: weight decreased. Injury, poisoning and procedural complications: very common: infusion reaction. Immune system disorders: uncommon: anaphylactic reaction. Observed in patients treated with isatuximab in combination with carfilzomib and dexamethasone: Infections/infestations: very common: pneumonia, upper respiratory tract infection, bronchitis: common: Herpes Zoster. Vascular disorder: very common: hypertension. Neoplasms benign, malignant and unspecified: common: Skin cancers and solid tumors non-skin cancers. Blood/lymphatic system disorders: common: neutropenia, anaemia, thrombocytopenia, unknown frequency: lymphopenia. Respiratory, thoracic and mediastinal disorders: very common: dyspnoea and cough. Gastrointestinal disorders: very common: diarrhoea and vomiting. General disorders and administration site conditions: very common: Fatigue. Injury, poisoning and procedural complications: very common: infusion reaction. Immune system disorders: uncommon: anaphylactic reaction. Reported in patients with multiple myeloma treated with isatuximab in combination with bortezomib, lenalidomide, and dexamethasone: Infections/infestations: very common: pneumonia, bronchitis, Covid-19. Neoplasms benign, malignant and unspecified: common: skin cancer, solid tumour, uncommon: haematology malignancy. Blood and lymphatic system disorders: very common: neutropenia, thrombocytopenia, common: anaemia, not known: lymphopenia. Immune system disorders: uncommon: anaphylactic reaction. Eye disorders: very common: cataract. Gastrointestinal disorders: very common: diarrhoea, common: vomiting. General disorders and administration site conditions: very common: fatigue. Injury, poisoning and procedural complications: very common: infusion reaction.

Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01FC02.

List of excipients: Sucrose, Histidine hydrochloride monohydrate, Histidine, Polysorbate 80 and Water for injections.

Legal classification: Prescription Only Medicine.

Marketing authorization holder: Sanofi Winthrop Industrie, 82, avenue Raspail, 94250 Gentilly, France.

Date of last revised: March 2025.

Abbreviated Prescribing Information based on the EU SmPC as of February 2025.

Before prescribing always refer to your full local prescribing information as this information may vary from country to country

MAT-GLB-2101917-v10.0-03/2025

Review the Summary of Product Characteristics.

United Arab Emirates Prescribing Information