Study Results: BCMA-naïve

ELREXFIO delivered deep responses^1,2

Deep response defined as ≥VGPR.³

Efficacy was based on response rate and duration of response. Among patients who had ≥4 lines of prior therapy (n=97)¹:

Primary endpoint: ORR*

Median follow-up was 10.2 months; range 0.2-20.1 months.²

Among responding patients, the majority (89.3% [50/56]) achieved ≥VGPR.¹

Median follow-up was 10.2 months; range 0.2-20.1 months.²

Among responding patients, the majority (89.3% [50/56]) achieved ≥VGPR.¹

Secondary endpoint: DoR*

Secondary endpoint: DoR^*

Secondary endpoint: PFS as assessed by BICR²

Median follow-up was 11.1 months (95% CI: 10.6-12.0) among responders.¹

References

As assessed by BICR.^1,2

CR was achieved by 13.4% (13/97) of patients and sCR was achieved by 12.4% (12/97) of patients.²

References

As assessed by BICR.^1,2

CR was achieved by 13.4% (13/97) of patients and sCR was achieved by 12.4% (12/97) of patients.²

Secondary endpoint: Median TTR*

Secondary endpoint: Median TTR^*

The analyses for median time to best response and complete response or better were not prespecified and not powered to detect statistical significance. Small patient numbers and lack of multiplicity adjustments can be limitations of these analyses.

Response data for patients who switched to Q2W dosing²

Analyses were post hoc and not powered to detect statistical significance. Small patient numbers and lack of multiplicity adjustments can be limitations of these analyses.

For patients who received at least 24 weeks of treatment and achieved a partial response or better and maintained this response for at least 2 months, the dose interval could be changed from QW to Q2W.¹

62.5% (35/56) of responding patients switched to Q2W dosing at least 12 weeks prior to the data cutoff date

Patients in MagnetisMM-3 who switched to Q2W dosing experienced a decrease from 58.6% to 46.6% in Grade 3/4 AEs (n=58).⁴

Treatment history and other selected prognostic factors in MM²

Treatment-related factors

Title

ELREXFIO may be appropriate for a range of patients you see in practice

Triple-class exposed^*

Triple-class refractory^†

Penta-drug exposed^‡

Penta-drug refractory^§

Other selected prognostic factors

Extramedullary disease^||

High-risk cytogenetics^¶

Age (≥75 years)

CrCI ≤60 mL/min

R-ISS

Median prior lines of therapy

n=97.¹

Triple-class exposed refers to having received at least 1 PI, 1 IMiD, and 1 anti-CD38 mAb.²

Triple-class refractory refers to refractory to at least 1 PI, 1 IMiD, and 1 anti-CD38 mAb.²

Penta-drug exposed refers to having received at least 2 PIs, 2 IMiDs, and 1 anti-CD38 mAb.²

Penta-drug refractory refers to refractory to at least 2 PIs, 2 IMiDs, and 1 anti-CD38 mAb.²

Defined by BICR as the presence of any plasmacytoma (extramedullary and/or paramedullary) with a soft tissue component.²

Defined as the presence of any of the following chromosomal abnormalities: t(4;14), t(14;16), and/or del(17P).²

BCMA=B-cell maturation antigen; BICR=Blinded Independent Central Review; CD=cluster of differentiation; CR=complete response; CrCl=creatinine clearance; DoR=duration of response; IMiD=immunomodulatory drug; mAb=monoclonal antibody; MM=multiple myeloma; NE=not evaluable; ORR=objective response rate; PI=proteasome inhibitor; PR=partial response; QW=every week; Q2W=once every 2 weeks; R-ISS=Revised International Staging System; sCR=stringent complete response; TTR=time to response; VGPR=very good partial response.

Report Adverse Events

Study Results: BCMA-exposed

Efficacy results in patients with prior BCMA-directed therapy

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References:

ELREXFIO Prescribing Information. New York, NY: Pfizer Inc.

Data on file. Pfizer Inc., New York, NY.

Harousseau J-L, Avet-Loiseau H, Attal M, et al. Achievement of at least very good partial response is a simple and robust prognostic factor in patients with multiple myeloma treated with high-dose therapy: long-term analysis of the IFM 99-02 and 99-04 trials. J Clin Oncol. 2009;27:5720-5726. doi:10.1200/JCO.2008.21.1060

Lesokhin AM, Tomasson MH, Arnulf B, et al. Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results. Nat Med. 2023;29:2259-2267. doi:10.1038/s41591-023-02528-9

Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma V.4.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed May 1, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org.

NCCN Clinical Practice Guidelines In Oncology (NCCN Guidelines®)

NCCN Category 2A Preferred

Elranatamab-bcmm (ELREXFIO™) is a Category 2A, Preferred treatment option for multiple myeloma patients after at least four prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent, recommended by the NCCN Guidelines^®.^5*

*See the NCCN Guidelines for detailed recommendations, including other preferred options.

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NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

Important Safety Information

WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME

Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving ELREXFIO. Initiate treatment with ELREXFIO step-up dosing to reduce risk of CRS. Withhold ELREXFIO until CRS resolves or permanently discontinue based on severity.

Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS) and serious and life-threatening reactions, can occur in patients receiving ELREXFIO. Monitor patients for signs and symptoms of neurologic toxicity, including ICANS, during treatment. Withhold ELREXFIO until the neurologic toxicity resolves or permanently discontinue based on severity.

Because of the risk of CRS and neurologic toxicity, including ICANS, ELREXFIO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called ELREXFIO REMS.

Cytokine Release Syndrome (CRS): ELREXFIO can cause CRS, including life-threatening or fatal reactions. In the clinical trial, CRS occurred in 58% of patients who received ELREXFIO at the recommended dose, with Grade 1 CRS in 44% of patients, Grade 2 CRS in 14% of patients, and Grade 3 CRS in 0.5% of patients. Recurrent CRS occurred in 13% of patients. Most patients experienced CRS after the first step-up dose (43%) or the second step-up dose (19%), with 7% of patients having CRS after the first treatment dose and 1.6% of patients after a subsequent dose. The median time to onset of CRS was 2 (range: 1-9) days after the most recent dose, with a median duration of 2 (range: 1-19) days.

Clinical signs and symptoms of CRS may include, but are not limited to, fever, hypoxia, chills, hypotension, tachycardia, headache, and elevated liver enzymes.

Initiate therapy according to the ELREXFIO step-up dosing schedule to reduce risk of CRS and monitor patients following administration of ELREXFIO accordingly. Administer pretreatment medications prior to each dose in the step-up dosing schedule to reduce risk of CRS.

Counsel patients to seek medical attention should signs or symptoms of CRS occur. At the first sign of CRS, evaluate patients immediately for hospitalization. Manage CRS according to the recommendations and consider further management per current practice guidelines. Withhold or permanently discontinue ELREXFIO based on severity.

Neurologic Toxicity Including ICANS: ELREXFIO can cause serious or life-threatening neurologic toxicity, including ICANS.

In the clinical trial, neurologic toxicity occurred in 59% of patients who received ELREXFIO at the recommended dose, with Grade 3 or 4 neurologic toxicity occurring in 7% of patients. Neurologic toxicities included headache (18%), encephalopathy (15%), motor dysfunction (13%), sensory neuropathy (13%), and Guillain-Barré Syndrome (0.5%).

In the clinical trial, ICANS occurred in 3.3% of patients who received ELREXFIO at the recommended dose. Most patients had ICANS after the first step-up dose (2.7%), 1 (0.5%) patient had ICANS after the second step-up dose, and 1 (0.5%) patient had ICANS after subsequent dose(s). Recurrent ICANS occurred in 1.1% of patients. The median time to onset was 3 (range: 1-4) days after the most recent dose, with a median duration of 2 (range: 1-18) days. The most frequent clinical manifestations of ICANS included a depressed level of consciousness and Grade 1 or Grade 2 immune effector cell-associated encephalopathy (ICE) scores. The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS.

Counsel patients to seek medical attention should signs or symptoms of neurologic toxicity occur. Monitor patients for signs and symptoms of neurologic toxicities during treatment with ELREXFIO. At the first sign of neurologic toxicity, including ICANS, evaluate and treat patients immediately based on severity. Withhold or permanently discontinue ELREXFIO based on severity per recommendations and consider further management per current practice guidelines.

Due to the potential for neurologic toxicity, including ICANS, patients receiving ELREXFIO are at risk of depressed level of consciousness. Advise patients not to drive or operate heavy or potentially dangerous machinery for 48 hours after completing each of the 2 step-up doses and the first treatment dose within the ELREXFIO step-up dosing schedule and in the event of new onset of any neurologic toxicity symptoms until symptoms resolve.

REMS: ELREXFIO is available only through a restricted program under a REMS called the ELREXFIO REMS because of the risks of CRS and neurologic toxicity, including ICANS.

Hepatotoxicity: ELREXFIO can cause hepatotoxicity. In the clinical trial, elevated ALT occurred in 36% of patients, with Grade 3 or 4 ALT elevation occurring in 3.8%; elevated AST occurred in 40% of patients, with Grade 3 or 4 AST elevation occurring in 6%. Grade 3 or 4 total bilirubin elevations occurred in 0.5% of patients. Liver enzyme elevation can occur with or without concurrent CRS.

Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. Withhold ELREXFIO or consider permanent discontinuation of ELREXFIO based on severity.

Infections: ELREXFIO can cause severe, life-threatening, or fatal infections. In the clinical trial, in patients who received ELREXFIO at the recommended dose, serious infections, including opportunistic infections, occurred in 42% of patients, with Grade 3 or 4 infections in 31% and fatal infections in 7%. The most common serious infections reported (≥5%) were pneumonia and sepsis.

Do not initiate treatment with ELREXFIO in patients with active infections. Monitor patients for signs and symptoms of infection prior to and during treatment with ELREXFIO and treat appropriately. Withhold or permanently discontinue ELREXFIO based on severity. Administer prophylactic antimicrobial and antiviral medications according to current practice guidelines. Consider treatment with subcutaneous or intravenous immunoglobulin (IVIG) as appropriate.

Neutropenia: ELREXFIO can cause neutropenia and febrile neutropenia. In patients who received ELREXFIO at the recommended dose in the clinical trial, decreased neutrophils occurred in 62% of patients, with Grade 3 or 4 decreased neutrophils in 51%. Febrile neutropenia occurred in 2.2% of patients.

Monitor complete blood cell counts at baseline and periodically during treatment. Provide supportive care according to current practice guidelines. Monitor patients with neutropenia for signs of infection. Withhold ELREXFIO based on severity.

Embryo-Fetal Toxicity: Based on its mechanism of action, ELREXFIO may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with ELREXFIO and for 4 months after the last dose.

Adverse Reactions: In patients who received ELREXFIO, the most common adverse reactions (incidence ≥20%) were CRS, fatigue, injection-site reaction, diarrhea, upper respiratory tract infection, musculoskeletal pain, pneumonia, decreased appetite, rash, cough, nausea, and pyrexia. The most common Grade 3 or 4 laboratory abnormalities (≥30%) were decreased lymphocytes, decreased neutrophils, decreased hemoglobin, decreased white blood cells, and decreased platelets.

Please see full Prescribing Information, including BOXED WARNING, and Medication Guide for ELREXFIO.

ELREXFIO™ (elranatamab-bcmm) is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).

Indication and Usage