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Unmet Need in Multiple MyelomaMode of ActionAboutReimbursement InformationStudy OverviewStudy Design and Baseline DemographicsEfficacy OutcomesFollow-up Analyses OutcomesSafety ProfileMagnetisMM-3 StudySafetyDosingMaterialsVideosEventsService SupportSupport & Resources

The content of this website has been produced in line with the ELREXFIO®▼ (elranatamab) Summary of Product Characteristics. For Elrexfio®▼ (elranatamab) Prescribing Information for United Kingdom click here.​

MagnetisMM-3 Study: Follow-up Analyses Outcomes

In the primary analysis (median duration of follow-up was 15.2 months)* and follow-up analyses (median durations of follow-up were 17.6 for PFS months and 28.4 months for mOS and DoR)† of the MagnetisMM-3 study, response rate and survival data demonstrated continued ELREXFIO® efficacy over, time with no new safety signals in patients with no prior BCMA-directed therapy.1,2,3

With extended follow-up (median follow-up of 28.4 months), ELREXFIO continued to deliver deep‡ and durable responses in some patients with no prior BCMA-directed therapy 2,3Objective response rate (ORR; primary endpoint)§

With a median follow-up of 28.4 months (95% CI: 28.0-29.0), ORR§ assessed by BICR per International Myeloma Working Group criteria (primary endpoint) remained at 61.0% (n=75/123).1,3

Adapted from ELREXFIO® Summary of Product Characteristics and Mohty M, Iida S, Bahlis NJ, et al.1,3

Minimal residual disease (MRD) negativity rate was 90.3% in patients with CR or better who were evaluable for MRD at the threshold of 10-5 next generation sequencing clonoSEQ assay (n=31).1,3

Duration of response (DoR; secondary endpoint)

With a median follow-up of 28.4 months (95% CI: 28.0-29.0), the median duration of response (secondary endpoint) among responders was not reached. The probability of maintaining a response at 2 years was 66.9% (95% CI: 54.4-76.7) among all responders and was 87.9% (95% CI: 73.1-94.8) in patients with complete response (CR) or better.3

Median duration of response (secondary endpoint)1,5

Adapted from Mohty, M. et al. Abstract P932.3

Data cutoff: 26 March 2024 (median follow-up of 28.4 months [95% CI: 28.0-29.0]).  

With a median follow-up of 17.6 months, ELREXFIO demonstrated a median progression-free survival (PFS; secondary endpoint) of 17.2 months in patients with no prior BCMA-directed therapy2

PFS was defined as the time from the first dose to confirmed PD or death due to any cause (whichever was earlier) or censoring.4 

Adapted from Tomasson M, et al. Poster presented at the 65th American Society of Hematology Annual Meeting.2 

Data cutoff: 11 September 2023 (median follow-up of 17.6 months [range: 0.2-31.1]).

Limitation: Longer-term follow-up is required to confirm the benefits in PFS. These data should be interpreted with caution due to no comparator time to event.2 

With extended follow-up (median follow-up of 28.4 months), ELREXFIO demonstrated a median overall survival (OS; secondary endpoint) of >2 years in patients with no prior BCMA-directed therapy3

With a median follow-up of 28.4 months (95% CI: 28.0-29.0), the median OS (secondary endpoint) was 24.6 months (95% CI: 13.4-NE). This data cut-off was 24 months after the last enrolled patients' initial dose.3

Adapted from Mohty M, et al. Abstract P932.3
Data cutoff: 26 March 2024 (median follow-up of 28.4 months [95% CI: 28.0-29.0]).

At data cut-off (March 26, 2024), no new safety signals emerged with longer follow-up.6,7

References*In the primary analysis for the MagnetisMM-3 study, with a median follow-up of 15.2 months (range: 2.4-24.2), 61.0% (95% CI: 51.8-69.6; n=75/123) of patients with no prior BCMA-directed therapy achieved ORR and 35.7% (n=44/123) achieved CR/sCR.1

†Follow-up analyses took place after a median follow-up of 17.6 months (range: 0.2-31.1; data cutoff: 7 January 2022) and after a median follow-up of 28.4 months (95% CI: 28.0-29.0; data cutoff: 26 March 2024).2,3

‡Response assessed by BICR. Deep response defined as ≥CR.1,5

§ORR defined as sCR+CR+VGPR+PR.1BCMA: B-cell maturation antigen; BICR: blinded independent central review; CI: confidence interval; CR: complete response; DoR: duration of response; MM: multiple myeloma; MRD: minimal residual disease; NE: not evaluable; OR: objective response; ORR: objective response rate; PD: Progressive disease; PFS: progression-free survival; PR: partial response; RRMM: relapsed or refractory multiple myeloma; sCR: stringent complete response; SmPC: Summary of Product Characteristics; VGPR: very good partial responseReferences:ELREXFIO® Summary of Product Characteristics.Tomasson MH, Iida S, Niesvizky R, et al. Long-term efficacy and safety of elranatamab monotherapy in the phase 2 MagnetisMM-3 trial in relapsed or refractory multiple myeloma. Poster presented at the 65th American Society of Hematology Annual Meeting.Mohty M, Iida S, Bahlis NJ, et al. Long-term survival after elranatamab monotherapy in patients with relapsed or refractory multiple myeloma (RRMM). Poster presented at the Congress of the European Hematology Association 2024, Madrid, Spain; Abstract P932.Lesohkin AM, et al. Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results. Nature Medicine. 2023;29:2259-2267.Kumar S, et al. Lancet Oncol. 2016;17:e328-3346.PfizerLtd. Data on file. REF-E1A2582Tomasson M, Lida S, Lesokhin A, and Niesvizky R. et al. (2024). Long‐term survival and safety of elranatamab in patients with relapsed or refractory multiple myeloma: Update from the MagnetisMM‐3 study. Available at: https:// onlinelibrary.wiley.com/doi/10.1002/hem3.136.Dosing Details of the recommended ELREXFIO® step-up dosing and administration instructions  Read moreLoadingSafety 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-0553. January 2025

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