This site contains promotional information intended only for healthcare professionals resident in the United Kingdom

Visit Pfizer Medical site

Menu

Close

Sign InLog Out
  • EN
Single LinkDropdownLabelLinkLinkLinkLinkLinked DropdownLabelLinkLinkLinkLinkMega MenuHeading

Example of description text sitting alongside header

LabelLinkLinkLinkLinkLabelLinkLinkLinkLinkLabelLinkLinkLinkLink
Linked Mega MenuHeading

Example of description text sitting alongside header

LabelLinkLinkLinkLinkLabelLinkLinkLinkLinkLabelLinkLinkLinkLink
EN - EnglishSelect a languageLanguagesEN - EnglishFR - Françias

Menu

Close

Sign InLog Out
  • EN
Single LinkDropdownLabelLinkLinkLinkLinkLinked DropdownLabelLinkLinkLinkLinkMega MenuHeading

Example of description text sitting alongside header

LabelLinkLinkLinkLinkLabelLinkLinkLinkLinkLabelLinkLinkLinkLink
Linked Mega MenuHeading

Example of description text sitting alongside header

LabelLinkLinkLinkLinkLabelLinkLinkLinkLinkLabelLinkLinkLinkLink
EN - EnglishSelect a languageLanguagesEN - EnglishFR - Françias
Search

Menu

Close

Sign In or RegisterLog Out
Pfizer MedicinesTherapy AreasExplore ContentEventsVideosMaterialsFeatured ArticlesLet’s ConnectSupplyAlliance HealthcareOff-contract claims

Adverse event reporting can be found at the bottom of the page

Menu

Close

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.

MagnetisMM-3 Study: ELREXFIO®
demonstrated a generally manageable safety profile in BCMA-directed therapy-naïve patients1,2

MagnetisMM-3 Study Design  

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

Treatment-emergent adverse events (TEAEs) occurring in ≥20% of BCMA-directed therapy-naïve patients receiving ELREXFIO® (n=123)
  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])

Dose interruptions/modificationsIn BCMA-directed therapy-naïve patients receiving ELREXFIO® (n=123):
  • 13.8% (n=17) of patients permanently discontinued ELREXFIO® due to adverse events2,3  
  • 28.5% (n=35) of patients experienced dose reduction due to adverse events2,4
  • 77.2% (n=95) of patients experienced dose interruption due to adverse events2,5 
    • At 50.4% (n=62), infections were the most common cause of dose interruptions (25.2% (n=31) were COVID-19 related)2,5 
    • Of the patients undergoing dose interruptions due to infections who were rechallenged (n=46), 93.5% (n=43)  successfully resumed treatment‡6
InfectionsIn BCMA-directed therapy-naïve patients receiving ELREXFIO® (n=123):
  • 69.9% (n=86) of patients experienced infections (of these, 29.3% (n=36) were COVID-19 related)2,6 
    • 39.8% (n=49) of patients experienced a Grade 3 of Grade 4 reaction6  
    • 6.5% (n=8) of patients had a fatal infection6  
  • Anti-infectious prophylaxis§ was given per local standards of care
    • Concomitant medications administered as prophylaxis for infection included anti-viral (87.0% of patients, n=107), anti-pneumocystis jirovecii pneumonia (49.6%, n=61), anti-fungal (11.4%, n=14) and anti-bacterial (5.7%, n=7)2,7 
CRS and ICANS
  • Of the 119 patients who received the two step-up priming dose ELREXFIO® regimen, CRS occurred in 56.3% (n=67) of patients. Of these:2,8
    • All CRS events were Grade 1 (42.0%, n=50) or Grade 2 (14.3%, n=17) 
    • No Grade 3 or higher events were reported  
    • CRS events generally occurred early in treatment, with 98.8% occurring in the first three doses and 90.6% limited to the step-up doses  
    • No permanent treatment discontinuations were due to CRS events
  • Of the 119 patients who received the two step-up priming dose ELREXFIO® regimen, ICANS occurred in 3.4% (n=4) of patients. Of these:2,9
    • All ICANS events were Grade 1 or Grade 2 
    • No Grade 3 or higher events were reported 
    • No permanent treatment discontinuations were due to ICANS events
*Includes preferred terms in COVID-19 (narrow) standardised Medical Dictionary tor Regulatory Activities (MedDRA) queries.2 †25/36 (69.4%) patients developed COVID-19 or COVID-19 pneumonia and 10/36 (30.6%) only had a positive SARS-CoV-2 test without developing the disease.2 ‡Defined as able to resume treatment following a dose interruption due to an AE and not discontinued permanently due to the same AE type.2 §Criteria for distinguishing antimicrobial agent administration for prophylaxis vs other indication (e.g. treatment of active infection) included continuous treatment for at least 14 days and not administered to treat an adverse event.2ReferencesAE: adverse event; BCMA: B-cell maturation antigen; CRS: cytokine release syndrome; ICANS: immune effector cell-associated neurotoxicity syndrome; IMiD: immunomodulatory drug; CD38: cluster of differentiation 38; POEMS: polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma cell disorder, skin changes; TEAE: treatment-emergent adverse event; RRMM: relapsed refractory multiple myeloma; SC: subcutaneous; SmPC: Summary of Product Characteristics; QW: once-weekly; Q2W: once every 2 weeksReferences:ELREXFIO® Summary of Product Characteristics. Click here for Great Britain. Click here for Northern Ireland.Lesokhin AM, et al. Nature Med. 2023;29:2259-2267. Pfizer Ltd. Data on File. REFL1A0242Pfizer Ltd. Data on File. REFL1A0244Pfizer Ltd. Data on File. REFL1A0243Pfizer Ltd. Data on File. REFE1A2163Pfizer Ltd. Data on File. REFE1A2162Pfizer Ltd. Data on File. REFL1A0241Pfizer Ltd. Data on File. REFE1A2160
DosingDetails of the recommended ELREXFIO® step-up dosing and administration instructions  Read moreLoadingELREXFIO® safety profileSafety profile of ELREXFIO® in all patients treated at the recommended dose in the Phase 2 MagnetisMM-3 study (n=183) Read moreLoading
PP-L1A-GBR-0024. 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

PfizerPro Account

To access further materials, resources and receive communication about medicines and vaccines promoted by Pfizer.

Sign In or RegisterAccountSign Out

This site is intended only for healthcare professionals resident in the United Kingdom. If you are a member of the public wishing to access information on a specific medicine, please visit www.medicines.org.uk/emc

 

This website is brought to you by Pfizer Limited, a company registered in England 

and Wales under No. 526209 with its registered office at Ramsgate Road, Sandwich, Kent, CT13 9NJ

 

Copyright © 2024 Pfizer Limited. All rights reserved.

 

VAT registration number GB201048427

PP-UNP-GBR-7866. January 2024
For UK Healthcare Professionals*

These pages are not intended for patients or for members of the general public. The healthcare professional web pages contain promotional content.

I confirm that I am a healthcare professional* resident in the United Kingdom.

If you select 'No', you will be redirected to Pfizer.co.uk where you will be able to access reference information on Pfizer's prescription medicines.

*The ABPI Code definition for healthcare professional is members of the medical, dental, pharmacy and nursing professionals and any other persons who in the course of their professional activities may administer, prescribe, purchase, recommend or supply a medicine.

PP-UNP-GBR-7812. January 2024

YesNo
You are now leaving PfizerPro​​​​​

​​​​​​​You are now leaving www.pfizerpro.co.uk. Links to external websites are provided as a resource to the viewer. This website is neither owned or controlled by Pfizer Ltd. 

Pfizer accepts no responsibility for the content or services of the linked site.​​​​​​​​​​​​​​

​​​​​​​PP-PFE-GBR-3858. November 2021​​​​​​​
​​​​​​​
You are now leaving PfizerPro
​​​​​​​
​​​​​​​You are now leaving www.pfizerpro.co.uk. Links to external websites are provided as a resource to the viewer. This website is neither owned nor controlled by Pfizer Ltd. 

Pfizer accepts no responsibility for the content or services of the linked site other than the information or other materials relating to ​​​​​Pfizer medicines or 
business which it has provided or reviewed.

PP-PFE-GBR-3859. November 2021
​​​​​​​