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Adverse event reporting can be found at the bottom of the page
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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.
MagnetisMM-3 (trial ongoing) is an open-label, global, multicentre, non-randomised Phase 2 study evaluating ELREXFIO® monotherapy in patients with relapsed or refractory multiple myeloma (RRMM), refractory to at least 1 proteasome inhibitor (PI), 1 immunomodulatory drug (IMiD), and 1 anti-CD38 monoclonal antibody.1
The primary endpoint is objective response rate (ORR) as assessed by blinded independent central review (BICR). Key secondary endpoints include: minimal residual disease (MRD) negativity rate (10-5), time to response (TTR), duration of response (DoR), progression-free survival (PFS), complete response rate (CRR), and safety.1
Adapted from ELREXFIO® Summary of Product Characteristics.1
*The dosing interval was changed from QW to Q2W in patients who achieved an IMWG response category of partial response or better with responses persisting for at least 2 months.1
BCMA-directed therapy-naïve patients (n=123) | ||
---|---|---|
All grades, n (%) | Grade 3/4, n (%) | |
Any TEAE | 123 (100) | 87 (70.7) |
Haematologic | ||
Anaemia | 60 (48.8) | 46 (37.4) |
Neutropenia | 60 (48.8) | 60 (48.8) |
Thrombocytopenia | 38 (30.9) | 29 (23.6) |
Lymphopenia | 33 (26.8) | 31 (25.2) |
Non-haematologic | ||
CRS | 71 (57.7) | 0 |
Diarrhoea | 52 (42.3) | 2 (1.6) |
Fatigue | 45 (36.6) | 4 (3.3) |
Decreased appetite | 41 (33.3) | 1 (0.8) |
Pyrexia | 37 (30.1) | 5 (4.1) |
COVID-19 related* | 36 (29.3)† | 19 (15.4) |
Injection site reaction | 33 (26.8) | 0 |
Nausea | 33 (26.8) | 0 |
Hypokalaemia | 32 (26.0) | 13 (10.6) |
Cough | 31 (25.2) | 0 |
Headache | 29 (23.6) | 0 |
Adapted from Lesohkin AM, et al. Nature Med. 2023.2
Data cutoff: 14 March 2023 (except from CRS and ICANS data which were 12 January 2023).(Median follow-up was 14.7 months [range 0.2-25.1 months])
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search
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PP-UNP-GBR-7812. January 2024