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Unmet Need in Multiple MyelomaMode of ActionAboutReimbursementStudy OverviewStudy Design and Baseline DemographicsEfficacy OutcomesFollow-up Analyses OutcomesClinical StudySafetyDosingMaterialsVideosEventsService SupportContact UsSupport & 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.​ ELREXFIO® (elranatamab) has a conditional marketing authorisation. A conditional marketing authorisation means that further evidence of efficacy and safety data are being collected. New information on this medicinal product will be reviewed when any relevant information of significance becomes available and at least every year. The licensing authority will review new information on this medicine at least every year and update the Summary of Product Characteristics as necessary.

MagnetisMM-3 Study: Follow-up Analyses Outcomes
In the primary analysis (median duration of follow-up was 14.7 months)* and follow-up analysis (median duration of follow-up was 33.9 months)† 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
With extended follow-up (median follow-up of 33.9 months), ELREXFIO® continued to deliver deep‡ and durable responses in some patients with no prior BCMA-directed therapy 2Objective response rate (ORR; primary endpoint and extended follow-up analysis)§
With a median follow-up of 14.7 months (range 0.2-25.1), ORR§ assessed by BICR per International Myeloma Working Group criteria (primary endpoint) was 61.0% (n=75/123).1 After 33.9 months follow-up, the ORR remained 61% (75/123).2,4

Minimal residual disease (MRD) negativity rate was 90.3% (28/31) in patients with CR or better who were evaluable for MRD at the threshold of 10-5 next generation sequencing clonoSEQ assay.1

Adapted from Lesokhin AM, et al. Nat Med. 2023; Pfizer Ltd. Data on file REF-L1A2168; Prince HM, et al. Poster presented at the 66th ASH Annual Meeting; Poster 4738; and Pfizer Ltd. Data on file REF-L1A2110.1–4
Minimal residual disease (MRD) negativity rate was 90.3% (28/31) in patients with CR or better who were evaluable for MRD at the threshold of 10-5 next generation sequencing clonoSEQ assay.5
Duration of response (DoR; secondary endpoint)
With a median follow-up of 33.9 months (95% CI 33.4-34.6), the median duration of response (secondary endpoint) among responders was not reached. The probability of maintaining a response at 30 months was 61.0% (95% CI 47.8–71.8) among patients with OR and was 79.1% (62.1–89.0) among patients with CR or better.2

Median duration of response (secondary endpoint)1,5

Adapted from Prince HM, et al. Poster presented at the 66th ASH Annual Meeting 2024. Poster 4738.2

Data cutoff: 10 September 2024 (median follow-up of 33.9 months 95% CI 33.4-34.6).  

With a median follow-up of 33.9 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.1

Adapted from Prince HM, et al. Poster presented at the 66th ASH Annual Meeting 2024. Poster 4738.2 

Data cutoff: 10 September 2024 (median follow-up of 33.9 months [95% CI 33.4-34.6]).

Limitation: These data reflect a prespecified secondary endpoint and are presented for descriptive purposes only. The analysis was not powered to detect statistical significance. Limitations include a small sample size and the absence of multiplicity adjustment. Therefore, the findings should be interpreted with caution.1,5 

With extended follow-up (median follow-up of 33.9 months [95% CI 33.4-34.6]), ELREXFIO® demonstrated a median overall survival (OS; secondary endpoint) of >2 years in patients with no prior BCMA-directed therapy2

With a median follow-up of 33.9 months (95% CI 33.4–34.6), the median OS (secondary endpoint) was 24.6 months (95% CI: 13.4-NE). This data cut-off was 10 September 2024.2

Adapted from Prince HM, et al. Poster presented at the 66th ASH Annual Meeting 2024. Poster 4738.2

Data cutoff: 10 September 2024 (median follow-up of 33.9 months (95% CI 33.4–34.6)).

At data cut-off (March 26, 2024), no new safety signals emerged with longer follow-up.5
References*In the primary analysis for the MagnetisMM-3 study, with a median follow-up of 14.7 months (range 0.2–25.1), 61.0% (95% CI: 51.8-69.6; n=75/123) of patients with no prior BCMA-directed therapy achieved ORR and 35.0% (n=43/123) achieved CR/sCR.1

†Follow-up analyses took place after a median follow-up of 33.9 months (95% CI 33.4-34.6; data cutoff: 10 September 2024).2

‡Response assessed by BICR. Deep response defined as ≥CR.5,6

§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:Lesohkin AM, et al. Nature Medicine. 2023;29:2259–2267.Prince HM, et al. Poster presented at the 66th American Society of Hematology (ASH) Annual Meeting; December 7-10, 2024. San Diego, CA, USA. Poster 4738.Pfizer Ltd. Data on file REF-L1A2168.  Pfizer Ltd. Data on file REF-L1A2110.ELREXFIO® Summary of Product Characteristics.Kumar S, et al. Lancet Oncol. 2016;17:e328–e346.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-0554. January 2025

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