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Unmet Need in Multiple MyelomaMode of ActionAboutReimbursement InformationMagentisMM-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®▼ delivered deep*† and durable responses in some BCMA-directed therapy-naïve patients1-5 

*Deep response defined as ≥CR.8 
†As assessed by BICR.1 

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

Baseline Patient Characteristics:
Patients with no prior BCMA-directed therapy (Cohort A)

Patient demographics and key prognostic factors for MM1,2

  BCMA-directed therapy-naïve
(n=123)
Median age (range), years 68.0 (36-89)
Male, n (%) 68 (55.3)
Female, n (%) 55 (44.7)
Race, n (%)
White
Asian
Hispanic/Latino
Black or African American		 72 (58.5)
16 (13.0)
11 (8.9)
9 (7.3)
Extramedullary disease,* n(%) 39 (31.7)
High cytogenic risk,† n(%) 31 (25.2)
Revised International Staging System (R-ISS stage), n(%)
I
II
III		 28 (22.8)
68 (55.3)
19 (15.4)
Median lines of prior therapy, n (range) 5 (2-22)
Triple-class refractory, n (%) 119 (96.7)
Refractory to last line of therapy, n (%) 118 (95.9)
Prior allogenic stem cell transplantation, n (%) 7 (5.7)
Prior autologous stem cell transplantation, n (%) 84 (68.3)

Adapted from ELREXFIO® Summary of Product Characteristics and Pfizer Data on File. REF-E1A2136.1

Please note that percentages may not total 100 due to rounding. 
*Defined as the presence of any plasmacytoma (extramedullary and/or paramedullary with a soft tissue component).1 †Includes the following chromosomal abnormalities: t(4;14), t(14;16), and del(17p).1

ELREXFIO® delivered deep responses in some patients with no prior BCMA-directed therapy*†1 

With a median follow-up of 15.2 months (range: 2.4-24.2):1

  • 61.0% (95% CI: 51.8-69.6; n=75) of BCMA-directed therapy-naïve patients (n=123) achieved an ORR (primary endpoint)†‡2 
    • 35.8% (95% CI: 27.3-44.9; n=44) of BCMA-directed therapy-naïve patients (n=123) achieved a complete response (secondary endpoint)*§2​​​​​​​
 
  • 89.7% (95% CI: 72.7-97.8; n=26) of evaluable patients with a CR/sCR (n=29) achieved MRD negativity (secondary endpoint)¶2
    • ​​​​​​​Note, the analyses for minimal residual disease rate were not powered to detect statistical significance and should be interpreted with caution.
Primary endpoint: Objective response rate as assessed by BICR1 

Median duration of response (secondary endpoint)1,5

Adapted from ELREXFIO® Summary of Product Characteristics and Pfizer Data on File. REF-E1A2156.1,3

Median duration of follow-up for the primary endpoint was 15.2 months (range: 2.4-24.2)1 

The analyses for time to CR or better were not powered to detect statistical significance and should be interpreted with caution.

Secondary endpoint: Median time to first response1,3

Adapted from ELREXFIO® Summary of Product Characteristics and Pfizer Data on File. REF-E1A2156.1,3

Median duration of follow-up for the primary endpoint was 15.2 months (range: 2.4-24.2)1 

The analyses for time to CR or better were not powered to detect statistical significance and should be interpreted with caution.

Secondary endpoint: Median time to complete response or better1,3

Adapted from ELREXFIO® Summary of Product Characteristics and Pfizer Data on File. REF-E1A2156.1,3

Median duration of follow-up for the primary endpoint was 15.2 months (range: 2.4-24.2)1 

The analyses for time to CR or better were not powered to detect statistical significance and should be interpreted with caution.

Responses were observed across a range of patient subgroups4

ORR by treatment- and disease-related factors4

Example

ORR by patient-related factors4

Example

Adapted from Pfizer Ltd. Data on File. REF-E1A2157.4

These data represent prespecified subgroup analyses and are presented for descriptive purposes only. Small patient numbers and lack of multiplicity adjustment can be limitations of these analyses. No conclusion about efficacy in subgroups can be drawn from these data.

ELREXFIO® delivered durable responses in patients with no prior BCMA-directed therapy1,5 

With a median follow-up of 15.2 months (range: 2.4-24.2 months), the median duration of response was not reached in patients with no prior BCMA-directed therapy. Response rate at 15 months was 70.8% (95% CI: 58.2-80.2).1

Median duration of response (secondary endpoint)1,5

Adapted from Pfizer Ltd. Data on File. REF-E1A2148.5

Median follow-up was 15.2 months (range: 2.4-24.2)1

These data represent a prespecified secondary endpoint and are presented for descriptive purposes only. This analysis is not powered to detect significance. Small patient numbers and lack of multiplicity adjustment can be limitations of this analysis. These data should be interpreted with caution.

With a median of 14.7 months, PFS was not reached in patients with no prior BCMA-directed therapy6
  • With a median follow-up of 14.7 months (range: 0.2-25.1 months), 50.9% of patients in the overall population (n=123) were progression-free (secondary endpoint)6
  • PFS was defined as the time from the first dose to confirmed PD or death due to any cause (whichever was earlier) or censoring1
  • The depth of response was associated with improved outcomes, with patients in ≥CR having longer PFS1
  • Limitation: Longer term follow-up is required to confirm the benefits of PFS6
  • These data should be interpreted with caution due to no comparator time to event

Adapted from Lesohkin AM, et al. Nature Med. 2023.6

Median duration of follow-up was 14.7 months (range: 0.2-15.1 months)6

References*Deep response defined as ≥CR.8 
†As assessed by BICR.1 
‡ORR defined as sCR+CR+VGPR+PR.1 
§Complete response rate defined as sCR + CR.1
¶By threshold 10-5 next generation sequencing clonoSEQ assay.1
|| Median time to complete response or better is a measure of the median time for patients to reach a response defined as ≥CR. This analysis was completed as part of the time to response secondary endpoint.3
**Indicates an estimate of PFS at 15 months (95% CI).1
††Indicates an estimate of PFS at 18 months (95% CI).7BCMA: B-cell maturation antigen; BICR: blinded independent central review; CI: confidence interval; CR: complete response; CRS: cytokine release syndrome; DoR: duration of response; ECOG PS: Eastern Cooperative Oncology Group performance status; ICANS: immune effector cell-associated neurotoxicity syndrome; IMiD: immunomodulatory drug; mAb: monoclonal antibody; MM: multiple myeloma; MRD: minimal residual disease; NE: not evaluable; OR: objective response; ORR: objective response rate; PI: proteasome inhibitor; POEMS: polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma cell disorder, skin changes; PR: partial response; R-ISS: revised international staging system; RRMM: relapsed or refractory multiple myeloma; SC: subcutaneous; sCR: stringent complete response; SmPC: Summary of Product Characteristics; VGPR: very good partial response; QW: once-weekly; Q2W: once every 2 weeksReferences:ELREXFIO® Summary of Product Characteristics. Click here for Great Britain. Click here for Northern Ireland.Pfizer Ltd. Data on File. REF-E1A2136.Pfizer Ltd. Data on File. REF-E1A2156.Pfizer Ltd. Data on File. REF-E1A2157.Pfizer Ltd. Data on File. REF-E1A2148.Lesohkin AM, et al. Nature Med. 2023;29(9):2259-2267.Tomasson MH, et al. ASH poster; abstract 3385. Kumar S, et al. Lancet Oncol. 2016;17:e328-3346. Dosing Details 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-0023. March 2024

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