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Unmet Need in Multiple MyelomaMode of ActionAboutMagentisMM-3 Study OverviewMagnetisMM-3 Study Design and Efficacy OutcomesMagnetisMM-3 Study Safety ProfileMagnetisMM-3 StudySafetyDosingMaterialsVideosSupport & Resources

The content of this website has been produced in line with the ELREXFIO®▼ (elranatamab) Summary of Product Characteristics for Great Britain and Northern Ireland. For ELREXFIO®▼ (elranatamab) Prescribing Information for Great Britain and Northern Ireland click here.

ELREXFIO® has demonstrated a generally manageable safety profile in multiple myeloma patients regardless of previous exposure to BCMA-directed therapy1​​​​​​

The safety database of ELREXFIO® includes 183 adult patients from the MagnetisMM-3 study, who received the recommended ELREXFIO® dosing regimen as monotherapy for multiple myeloma.

The MagnetisMM-3 study included patients who were refractory to at least one proteasome inhibitor, one immunomodulatory again and one anti-CD38 monoclonal antibody. These patients were either naive to prior BCMA-directed therapy (cohort A) OR had received prior BCMA-directed therapy or chimeric antigen receptor (CAR) T-cell therapy (cohort B). The median duration of treatment was 4.1 months (range: 0.03 to 20.3 months).​​​​​​

Adverse event reactions in patients receiving ELREXFIO® at the recommended dose*1-3 ​​​​​​
System organ class Adverse reaction  Frequency* 
(All grades)
n=183
Any grade, n (%) Grade 3 or 4, n (%)
Infections and infestations Pneumoniaa  Very common 68 (37.2) 45 (24.6)
Sepsisb Very common 33 (18.0) 23
(12.6)
Upper respiratory tract infection Very common 71
(38.8)
10
(5.5)
Urinary tract infection Very common 23
(12.6)
8
(4.4)
Blood and lymphatic system disorders Neutropenia Very common 82
(44.8)
79
(43.2)
Anaemia Very common 99
(54.1)
78
(42.6)
Thrombocytopenia Very common 66
(36.1)
48
(26.2)
Lymphopenia Very common 55
(30.1)
51
(27.9)
Leukopenia Very common 32
(17.5)
23
(12.6)
Febrile neutropenia  Common 5
(2.7)
5
(2.7)
Immune system disorders Cytokine release syndrome  Very common 106
(57.9)
1
(0.5)
Hypogammaglobulinaemia Very common 26
(14.2)
5
(2.7)
Metabolism and nutrition disorders Decreased appetite Very common 49
(26.8)
2
(1.1)
Hypokalaemia  Very common 42
(23.0)
16
(8.7)
Hypophosphataemia Common 12
(6.6)
1
(0.5)
Nervous system disorders Peripheral neuropathyc Very common 29
(15.8)
2
(1.1)
Headache Very common 35
(19.1)
0
(0)
Immune effector cell-associated neurotoxicity syndrome Common 6
(3.3)
2
(1.1)
Respiratory, thoracic and mediastinal disorders Dyspnoea Very common 35
(19.1)
9
(4.9)
Gastrointestinal disorders Diarrhoea Very common 69
(37.7)
2
(1.1)
Nausea  Very common 39
(21.3)
0
(0)
Skin and subcutaneous tissue disorders Rashd Very common 48
(26.2)
0
(0)
Dry skin Very common 39
(21.3)
0
(0)
Musculoskeletal and connective tissue disorders Arthralgia Very common 46
(25.1)
3
(1.6)
General disorders and administration site conditions Injection site reaction Very common 70
(38.3)
0
(0)
Pyrexia Very common 50
(27.3)
6
(3.3)
Fatigue  Very common 81
(44.3)
11
(6.0)
Investigations Transaminases increased Very common 31
(16.9)
10
(5.5)

Adapted from ELREXFIO® SmPC; Pfizer Ltd. Data on File. REF-E1A2147; Pfizer Ltd. Data on File. REF-E1A2145.1-3
Data cut off: 16 Apr 2023 (median duration of follow-up was 15.2 months).

*Adverse reactions are listed according to the MedDRA system organ classification and by frequency. Frequency categories are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000) and not known (frequency cannot be estimated from the available data).1 

a. Pneumonia includes pneumonia, COVID-19 pneumonia, bronchopulmonary aspergillosis, lower respiratory tract infection bacterial, lower respiratory tract infection viral, pneumocystis jirovecii pneumonia, pneumonia adenoviral, pneumonia bacterial, pneumonia. cytomegaloviral, pneumonia fungal, pneumonia influenzal, pneumonia pseudomonal, pneumonia viral, atypical pneumonia, coronavirus pneumonia, pneumonia haemophilus, pneumonia pneumococcal, pneumonia respiratory syncytial viral. 
b. Sepsis includes sepsis, bacteraemia, device related bacteraemia, device related sepsis, escherichia bacteraemia, escherichia sepsis, klebsiella sepsis, pseudomonal sepsis, septic shock, staphylococcal bacteraemia, staphylococcal sepsis, streptococcal sepsis, urosepsis, campylobacter bacteraemia. 
c. Peripheral neuropathy includes peripheral sensory neuropathy, paraesthesia, peripheral sensorimotor neuropathy, dysaesthesia, neuropathy peripheral, peripheral motor neuropathy, guillain-barre syndrome, hypoaesthesia, neuralgia, polyneuropathy. 
d. Rash incudes dermatitis exfoliative, dermatitis exfoliative generalised, erythema, palmar-plantar erythrodysaesthesia syndrome, rash, rash erythematous, rash macular, rash maculo-papular, rash pustular, symmetrical drug-related intertriginous and flexural exanthema, epidermolysis.
 

Of the patients experiencing cytokine release syndrome (CRS) in the MagnetisMM-3 study, CRS events were manageable, with early onset and short duration1

57.9% of patients (n=106) receiving ELREXFIO® at the recommended dose in the MagnetisMM-3 trial (n=183) experienced CRS of any grade.1,4​​​​​

CRS events were manageable and resolved with appropriate interventions. Among patients who experienced CRS (n=106):1,4

  • Associated symptoms included: fever, hypoxia and hypotension
  • 33.0% (n=35) of patients received tocilizumab (or siltuximab) 
  • 15.1% (n=16) of patients received corticosteroids
The majority of CRS events occurred after the first step-up dose of ELREXFIO® (n=183)1
  • Recurrent CRS occurred in 13.1% (n=24) of patients1,4

Adapted from ELREXFIO® SmPC.1

Please refer to the ELREXFIO® SmPC for full symptom monitoring and early intervention information for CRS.

A minority of patients experienced ICANS events; most events were Grade 1 or 2, with early onset and short duration1​​​​​​

In patients receiving ELREXFIO® at the recommended dose in the MagnetisMM-3 trial (n=183):1,5 

  • 3.3% (n=6) of patients experienced ICANS events, with 2.7% (n=5) being after the first step-up dose  
  • Among patients who developed ICANS (n=6):1 
  • 66.7% (n=4) received corticosteroids 
  • 33.3% (n=2) received tocilizumab (or siltuximab) 
  • 33.3% (n=2)received levetiracetam  
  • 16.7% (n=1) received anakinra 
  • The most frequent symptoms of ICANS included a depressed level of consciousness and Grade 1 or Grade 2 Immune Effector Cell-Associated Encephalopathy (ICE) scores1
  • The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS1

Please refer to the ELREXFIO® SmPC for full symptom monitoring and early intervention information for ICANS. 

BCMA: B-cell maturation antigen; CAR: chimeric antigen receptor; CD38: cluster of differentiation 38; CRS: cytokine release syndrome; ICANS: immune effector cell-associated neurotoxicity syndrome; SmPC: Summary of Product Characteristics

References:

References:ELREXFIO® Summary of Product Characteristics. Click here for Great Britain. Click here for Northern Ireland.Pfizer Ltd. Data on File. REF-E1A2147.Pfizer Ltd. Data on File. REF-E1A2145.Pfizer Ltd. Data on File. REF-E1A2142. Pfizer Ltd. Data on FIle. REF-E1A2143.

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Unmet Need in Multiple MyelomaMode of ActionAboutMagentisMM-3 Study OverviewMagnetisMM-3 Study Design and Efficacy OutcomesMagnetisMM-3 Study Safety ProfileMagnetisMM-3 StudySafetyDosingMaterialsVideosSupport & Resources
DosingELREXFIO® step-up dosing schedule recommended to reduce the incidence and severity of CRS and ICANS Read moreLoading
MagnetisMM-3 overviewEfficacy and safety reported from the BCMA-directed therapy-naïve cohort of the Phase 2 MagnetisMM-3 study (n=123) Read moreLoading
PP-L1A-GBR-0027. March 2024

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search 

for MHRA Yellow Card in Google Play or Apple App Store

 

Adverse events should also be reported to Pfizer Medical Information on 01304 616161

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