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Sanofi

Sarclisa (isatuximab)

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IKEMA Adverse Reactions

Adverse Reaction Overview1

Upper respiratory tract infections, IRRs, fatigue, hypertension, pneumonia, diarrhea, dyspnea, insomnia, bronchitis and back pain were the most frequent adverse events reported in the SARCLISA® + Kd group and occurred in more than 20% of patients.

IRRs

45.8% (n=81) of patients treated with SARCLISA® in IKEMA experienced an IRR.

  • Grade 1 IRRs were reported in 13.6%, Grade 2 in 31.6% and Grade 3 in 0.6% of the patients treated with SARCLISA® + Kd
A graphic representing the percentage of IRRs, by Grade, experienced in the IKEMA study.
  • Signs and symptoms of Grade 3 IRRs included dyspnea and hypertension
  • The incidence of SARCLISA® infusion interruptions due to IRRs was 29.9%
  • The most common symptoms of an IRR included dyspnea, cough, nasal congestion, chills and nausea
  • Other reported symptoms included hypertension, hypoxia, pulmonary edema, hypotension, tachycardia, syncope, bronchospasm, cytokine release syndrome, anaphylactic reaction, face edema and hyperglycemia
  • SARCLISA® was discontinued in 0.6% of patients because of IRRs

IRR = infusion-related reaction; Kd = carfilzomib and dexamethasone.

Reference

  1. PrSARCLISA® Product Monograph. Sanofi Canada. January 12, 2024.

Treatment-Emergent Adverse Events1

  • The overall incidence of serious TEAEs was 59.3% in the SARCLISA® + Kd group and 57.4% in the Kd group
  • The most frequent serious adverse reactions (>5% of patients) were pneumonia (24.9% in the SARCLISA® + Kd group vs. 18.0% in the Kd group) and upper respiratory tract infections (9.0% in the SARCLISA® + Kd group vs. 8.2% in the Kd group)
  • Fatal AEs were reported in 3.4% of patients in the SARCLISA® + Kd group and 3.3% in the Kd group
    • Fatal AEs reported in >1% of patients were pneumonia and cardiac failure, both occurring in 1.1% of patients in the SARCLISA® + Kd group and in 0.8% of patients in the Kd group

Adverse reactions (≥10%) in patients receiving SARCLISA® + Kd with a difference between arms of ≥5% compared to Kd arm

Adapted from SARCLISA® Product Monograph.

*Infusion-related reaction includes infusion-related reaction, cytokine release syndrome and hypersensitivity.

†Upper respiratory tract infection includes acute sinusitis, chronic sinusitis, H1N1 influenza, H3N2 influenza, influenza, laryngitis, laryngitis viral, nasal herpes, nasopharyngitis, pharyngitis, pharyngotonsillitis, respiratory syncytial virus infection, rhinitis, sinusitis, sinusitis bacterial, tonsillitis, tracheitis, upper respiratory tract infection, viral rhinitis, respiratory tract infection, respiratory tract infection viral, influenza-like illness, parainfluenzae virus infection, respiratory tract infection bacterial and viral upper respiratory tract infection.

‡Pneumonia includes atypical pneumonia, lower respiratory tract infection, lower respiratory tract infection viral, pneumocystis jirovecii pneumonia, pneumonia, pneumonia influenzal, pneumonia legionella, pneumonia pneumococcal, pneumonia respiratory syncytial viral, pneumonia streptococcal, pneumonia viral, pulmonary sepsis and pulmonary tuberculosis.

§Bronchitis includes bronchitis, bronchitis viral, respiratory syncytial virus bronchitis, bronchitis chronic and tracheobronchitis.

¶Hypertension includes hypertension, blood pressure increased and hypertensive crisis.

**Dyspnea includes dyspnea and dyspnea exertional.

††Cough includes cough, productive cough and allergic cough.

‡‡Fatigue includes fatigue and asthenia.

Permanent discontinuation due to adverse reactions was reported in 8.5% of patients treated with SARCLISA® + Kd and in 13.9% of patients treated with Kd

AE = adverse event; Kd = carfilzomib and dexamethasone; TEAE = treatment-emergent adverse event.

Reference

  1. PrSARCLISA® Product Monograph. Sanofi Canada. January 12, 2024.

Hematologic Abnormalities and Treatment Discontinuation1

Treatment-emergent laboratory abnormalities in patients receiving SARCLISA® + Kd vs. Kd treatment

Adapted from SARCLISA® Product Monograph.

The denominator used for the percentage calculation was the number of patients with at least one evaluation of the laboratory test during the considered observation period.

CTCAE version: 4.03.

CTCAE = Common Terminology Criteria for Adverse Events; Kd = carfilzomib and dexamethasone.

Reference

  1. PrSARCLISA® Product Monograph. Sanofi Canada. January 12, 2024.

Infections1

  • The incidence of Grade 3 or higher infections was 38.4% in the SARCLISA® + Kd group
  • Pneumonia was the most commonly reported severe infection, with Grade 3 reported in 19.2% of patients in the SARCLISA® + Kd group compared with 14.8% in the Kd group, and Grade 4 in 3.4% of patients in the SARCLISA® + Kd group compared with 2.5% in the Kd group
  • Discontinuations of treatment due to infections were reported in 2.8% of patients in the SARCLISA® + Kd group compared with 4.9% in the Kd group
  • Fatal infections were reported in 2.3% of patients in the SARCLISA® + Kd group and in 0.8% in the Kd group

Kd = carfilzomib and dexamethasone.

Reference

  1. PrSARCLISA® Product Monograph. Sanofi Canada. January 12, 2024.

Warnings and Precautions: Neutropenia1

  • Neutropenia occurred as a laboratory abnormality in 54.8% of patients treated with SARCLISA® + Kd (Grade 3 = 17.5%; Grade 4 = 1.7%) 
  • Neutropenic complications occurred in 2.8% of patients, including febrile neutropenia (1.1%) and neutropenic infections (1.7%)
  • Monitor complete blood cell counts at baseline and periodically during treatment
  • Antibacterial, antifungal and antiviral prophylaxis can be considered during treatment
  • Monitor patients with neutropenia for signs of infection
  • SARCLISA® dose delays, modification of dexamethasone treatment, and the use of G-CSF may be required to allow improvement of neutrophil count

Dose Adjustment

  • No dose reductions of SARCLISA® are recommended
  • In case of Grade 3 and Grade 4 neutropenia, SARCLISA® administration should be delayed until neutrophil count improves to at least 1.0 x 109/L
  • The use of colony-stimulating factors (e.g., G-CSF) should be considered according to local guidelines
  • Temporary interruption or definitive discontinuation of SARCLISA® treatment may be required for neutropenia

G-CSF = granulocyte colony-stimulating factor; Kd = carfilzomib and dexamethasone.

Reference

  1. PrSARCLISA® Product Monograph. Sanofi Canada. January 12, 2024.