Demonstrated safety profile in the phase 3 
IKEMA study
  • Adverse Reactions
    Adverse Reactions in the Study Safety Population 
(reported in ≥20% of patients in the IsaKd arm)1
    IsaKd (n=177) Kd (n=122)
    All Grades ≥Grade 3 All Grades ≥Grade 3
    Most Common Infections (%)
    Upper respiratory tract infection* 66.7 9.0 57.0 7.0
    Pneumonia† 36.2 22.0 30.0 18.0
    Bronchitis‡ 23.7 2.3 13.0 0.8
    Most Common Adverse Reactions in Other Organ Systems (%)
    Infusion reactions§ 45.8 0.6 3.3 0
    Fatigue 41.8 5.0 32.0 3.3
    Hypertension∆ 37.3 21.0 32.0 20.0
    Diarrhea 36.2 2.8 29.0 2.5
    Dyspnea# 28.8 5.0 24.0 0.8
    Cough« 23.0 0 15.0 0
  • Serious Adverse Reactions
    Most Common Serious Adverse Reactions in the Study Safety Population Occurring with Incidences >5%1
    IsaKd (n=177) Kd (n=122)
    Pneumonia 24.9% 18.0%
    Upper respiratory tract infection 9.0% 8.2%
  • Treatment-Emergent Laboratory Abnormalities
    Treatment-Emergent Laboratory Abnormalities in the Study Safety Population1
    IsaKd (n=177) Kd (n=122)
    All Grades ≥Grade 3 All Grades ≥Grade 3
    Adverse Reaction (%)
    Anaemia 99.4 22.0 99.2 19.7
    Lymphopenia 94.4 68.9 95.1 57.3
    Thrombocytopenia 94.4 29.9 87.7 23.8
    Neutropenia 54.8 19.2 43.4 7.4

    The denominator used for the percentage calculation is the number of patients with at least 1 evaluation of the laboratory test during the considered observation period.

STUDY DESIGN
BASELINE
CHARACTERISTICS
Learn about the IKEMA Study by reading the trial abstract.
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* Upper respiratory tract infection includes acute sinusitis, chronic sinusitis, H1N1 influenza, H3N2 influenza, influenza, 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.

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

¶ Fatigue includes fatigue and asthenia.

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

# Dyspnea includes dyspnea and dyspnea exertional.

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

IsaKd, isatuximab + KYPROLIS + dexamethasone; Kd, KYPROLIS + dexamethasone.

Baseline characteristics were well-balanced between both groups14
Characteristics IsaKd (n=179) Kd (n=123)
Age
Median (years) 65 63
Range (years) 55–70 57–70
Distribution [number of patients (%)]
<65 88 (49) 66 (54)
65–74 years 74 (41) 47 (38)
≥75 years 17 (9) 10 (8)
ECOG Performance Status [number of patients (%)]
0 95 (53) 73 (59)
1 73 (40) 45 (37)
2 10 (6) 5 (4)
Cytogenic Risk at Study Entry [number of patients (%)]
High risk* 42 (23) 31 (25)
Standard risk 114 (64) 78 (63)
Unknown 23 (13) 14 (11)
Previous therapies in patients participating in the IKEMA study
ITT Population [number of patients (%)]14
Prior Therapies IsaKd (n=179) Kd (n=123)
1 prior line of therapy 79 (44) 55 (45)
2 prior lines of therapy 64 (36) 36 (29)
3 prior lines of therapy 33 (18) 30 (24)
Autologous transplant 116 (65) 69 (56)
Previous proteasome inhibitor 166 (93) 105 (85)
Previous immunomodulators 136 (76) 100 (81)
Previous lenalidomide 72 (40) 59 (48)
Prior daratumumab 1 (1) 0 (0)
Study eligibility:1
  • Patients with relapsed and/or refractory multiple myeloma
  • Patients must have received 1 to 3 prior lines of therapy
  • Patients were excluded if they had primary refractory disease or were refractory to previous anti-CD38 monoclonal antibody treatment

* High-risk cytogenetic status defined as the presence of del(17p) or translocation t(4;14) or translocation t(14;16).

ECOG, Eastern Cooperative Oncology Group; ITT, intent to treat; IsaKd, isatuximab + KYPROLIS + dexamethasone; Kd, KYPROLIS + dexamethasone.

IKEMA was a randomized, open-label, 2-arm, multicentre, phase 3 study with the following study design1
Patients with relapsed and/or refractory multiple myeloma who had received 1 to 3 prior lines of therapy (N=302) were randomized 3:2 to one of two groups: IsaKd twice weekly* (n=179) which consisted of KYPROLIS® (carfilzomib; 20/56 mg/m²), dexamethasone (20 mg), and isatuximab (10 mg/kg) or Kd twice weekly* (n=123) consisting of KYPROLIS® (carfilzomib; 20/56 mg/m²) and dexamethasone (20 mg). The primary endpoint was progression-free survival (PFS).

* Cycles were repeated until disease progression or unacceptable toxicity. Isatuximab was administered weekly in the first cycle and every two weeks in the following cycles.

PFS was determined by an Independent Review Committee.1

IsaKd, isatuximab + KYPROLIS + dexamethasone; Kd, KYPROLIS + dexamethasone; PFS, progression-free survival.