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MOAMOAStructural DesignMechanism of ActionBCMA as a Target in MMEfficacyEfficacyStudy DesignStudy Results: BCMA–naïveStudy Results: BCMA–exposedPatient ProfilesSafetySafetyCRSNeurologic ToxicityInfectionsAdverse ReactionsSelect Laboratory AbnormalitiesDosingTherapy ManagementTherapy ManagementELREXFIO Treatment JourneySerious Adverse Reaction ManagementResources and SupportResources and SupportEventsMaterialsVideosAccess SupportTreatment Locator
Prescribing InformationMedication GuideIndication ELREXFIO REMS Patient Site
The efficacy and safety of ELREXFIO were evaluated
in the MagnetisMM-3 study1,2The efficacy and safety of ELREXFIO were evaluated in the MagnetisMM-3 study1,2MagnetisMM-3 was an open-label, single-arm, non-randomized, multicenter, Phase 2 study of ELREXFIO monotherapy in patients with RRMM1,2MagnetisMM-3 was an open-label, single-arm, non-randomized, multicenter, Phase 2 study of ELREXFIO monotherapy in patients with RRMM1,2

Study design1,2

Baseline patient characteristics2

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Efficacy was based on response rate and duration of response among patients who had ≥4 lines of prior therapy (97 in Cohort A and 63 in Cohort B).1

Efficacy was based on response rate and durability of response among patients who had ≥4 lines of prior therapy (97 in Cohort A and 63 in Cohort B).1

Primary endpoint1,2,II:Primary endpoint1,2:
  • Objective response rate (ORR)
Selected secondary endpoints1,2:Selected secondary endpoints1,2:
  • Complete response rate (CRR)
  • Minimal residual disease (MRD) negativity rate
  • Duration of response (DoR)
  • Time to response (TTR)
  • Progression-free survival (PFS)*
  • Overall survival (OS)
  • Safety
Selected exploratory endpoint2:Selected exploratory endpoint2:
  • Patient-reported symptoms and functioning
Final analysis data cutoff: October 14, 2022.2Patient populations: Efficacy and enrolled

Post hoc extended follow-up of Cohort A looked at outcomes for (1) all 123 patients enrolled in Cohort A, as well as (2) the subset of 97 patients who had ≥4 prior lines of therapy (efficacy population).2,3

 Video Dr. Noa Biran discusses the MagnetisMM-3 study Watch nowLoadingHaving disease progression while on therapy or within 60 days of last dose in any line, regardless of response.2Patients with active or uncontrolled bacterial, fungal, or viral infection; POEMS syndrome; and those who received a stem-cell transplant within 12 weeks prior to enrollment were also excluded.2Four patients received a single step-up dose of 44 mg on Day 1 before receiving the first treatment dose of 76 mg QW starting on Day 8.2If patient received at least 24 weeks of treatment with ELREXFIO and achieved and maintained a partial response or better for at least 2 months, the dose interval could be changed from QW to Q2W.1As assessed by BICR.2​​​​​​​Included BICR and investigator assessments.1,2​​​​​​​ADC=antibody-drug conjugate; ANC=absolute neutrophil count; BCMA=B-cell maturation antigen; BICR=Blinded Independent Central Review; BsAb=bispecific antibody; CAR=chimeric antigen receptor; CD=cluster of differentiation; CrCl=creatinine clearance; ECOG=Eastern Cooperative Oncology Group; IMiD=immunomodulatory drug; mAb=monoclonal antibody; PI=proteasome inhibitor; POEMS=polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes; QW=once weekly; Q2W=once every 2 weeks; RRMM=relapsed or refractory multiple myeloma; SC=subcutaneous.Study Results: BCMA-naïveEfficacy results in patients without prior BCMA-directed therapy Explore more LoadingReferences:ELREXFIO Prescribing Information. New York, NY: Pfizer Inc.Data on file. Pfizer Inc., New York, NY.
Patient demographics
  Efficacy Population: BCMA-naïve 
(n=97)
Age, median 69
Age, n (%)
<75 79 (81.4)
≥75 18 (18.6)
Gender, n (%)
Male 58 (59.8)
Female 39 (40.2)
Race, n (%)
White 58 (59.8)
Black 5 (5.2)
Asian 13 (13.4)
Unknown/Not reported 21 (21.7)
Ethnicity, n (%)
Hispanic/Latino 7 (7.2)
  Enrolled Population: BCMA-naïve (N=123)
Age, median 68
Age, n (%)
<75 99 (80.5)
≥75 24 (19.5)
Gender, n (%)
Male 68 (55.3)
Female 55 (44.7)
Race, n (%)
White 72 (58.5)
Black 9 (7.3)
Asian 16 (13.0)
Unknown/Not reported 26 (21.1)
Ethnicity, n (%)
Hispanic/Latino 11 (8.9)
  Cohort B: BCMA-exposed (n=63)
Age, median 67
Age, n (%)
<75 51 (81.0)
≥75 12 (19.0)
Gender, n (%)
Male 30 (47.6)
Female 33 (52.4)
Race, n (%)
White 11 (8.9)
Black 11 (8.9)
Asian 11 (8.9)
Unknown/Not reported 11 (8.9)
Ethnicity, n (%)
Hispanic/Latino 7 (11.1)
  Efficacy Population: BCMA-naïve
(n=97)		 Enrolled Population: BCMA-naïve (N=123) Cohort B: 

BCMA-exposed

(n=63)
Age, median 69 68 67
Age, n (%)
<75 79 (81.4) 99 (80.5) 51 (81.0)
≥75 18 (18.6) 24 (19.5) 12 (19.0)
Gender, n (%)
Male 58 (59.8) 68 (55.3) 30 (47.6)
Female 39 (40.2) 55 (44.7) 33 (52.4)
Race, n (%)
White 58 (59.8) 72 (58.5) 43 (68.3)
Black 5 (5.2) 9 (7.3) 2 (3.2)
Asian 13 (13.4) 16 (13.0) 1 (1.6)
Unknown/Not reported 21 (21.7) 26 (21.1) 17 (27.0)
Ethnicity, n (%)
Hispanic/Latino 7 (7.2) 11 (8.9) 7 (11.1)
Selected prognostic factors in MM
  Efficacy Population: BCMA-naïve
(n=97)		 Enrolled Population: BCMA-naïve (N=123) Cohort B: 

BCMA-exposed

(n=63)
ECOG PS, n (%)
0-1 92 (94.8) 116 (94.3) 59 (93.7)
2 5 (5.2) 7 (5.7) 4 (6.3)
Bone marrow plasma cells ≥50%, n (%) 20 (20.6) 26 (21.1) 11 (17.5)
Extramedullary disease,* n (%) 33 (34.0) 39 (31.7) 37 (58.7)
High cytogenetic risk,† n (%) 22 (22.7) 31 (25.2) 13 (20.6)
R-ISS stage,n (%)
I 11 (17.5) 28 (22.8) 20 (20.6)
II 52 (53.6) 68 (55.3) 35 (55.6)
III 17 (17.5) 19 (15.4)  
 Renal function, n (%)
CrCl ≤60 mL/min 34 (35.1) 42 (34.1) 23 (36.5)
Defined by BICR as the presence of any plasmacytoma (extramedullary and/or paramedullary) with a soft-tissue component.2Defined by the presence of any of the following chromosomal abnormalities: t(4;14), t(14;16), and/or del(17P).2

 

 Efficacy Population: BCMA-naïve 
(n=97)
ECOG PS,n (%)
0-1 92 (94.8)
2 5 (5.2)
Bone marrow plasma cells ≥50%, n (%) 20 (20.6)
Extramedullary disease,* n (%) 33 (34.0)
High cytogenetic risk,† n (%) 22 (22.7)
R-ISS stage, n (%)
I 20 (20.6)
II 52 (53.6)
III 17 (17.5)
Renal function, n (%)
CrCl ≤60 mL/min 34 (35.1)
  Enrolled Population: BCMA-naïve (N=123)
ECOG PS, n (%)
0-1 116 (94.3)
2 7 (5.7)
Bone marrow plasma cells ≥50%, n (%) 26 (21.1)
Extramedullary disease,* n (%) 39 (31.7)
High cytogenetic risk,† n (%) 31 (25.2)
R-ISS stage, n (%)
I 28 (22.8)
II 68 (55.3)
III 19 (15.4)
Renal function, n (%)
CrCl ≤60 mL/min 42 (34.1)
  Cohort B: BCMA-exposed (n=63)
ECOG PS, n (%)
0-1 59 (93.7)
2 4 (6.3)
Bone marrow plasma cells ≥50%, n (%) 11 (17.5)
Extramedullary disease,* n (%) 37 (58.7)
High cytogenetic risk,† n (%) 13 (20.6)
R-ISS stage, n (%)
I 11 (17.5)
II 35 (55.6)
III 15 (23.8)
Renal function, n (%)
CrCl ≤60 mL/min 23 (36.5)
Defined by BICR as the presence of any plasmacytoma (extramedullary and/or paramedullary) with a soft-tissue component.2Defined by the presence of any of the following chromosomal abnormalities: t(4;14), t(14;16), and/or del(17P).2Treatment history Defined by BICR as the presence of any plasmacytoma (extramedullary and/or paramedullary) with a soft-tissue component.2Defined by the presence of any of the following chromosomal abnormalities: t(4;14), t(14;16), and/or del(17P).2
  Efficacy Population: BCMA-naïve
(n=97)		 Enrolled Population: BCMA-naïve (N=123) Cohort B: 

BCMA-exposed

(n=63)
Time since initial diagnosis (months), median 79.6 72.9 103.0
Prior lines of therapy, median (range) 5.0 (4-22) 5.0 (2-22) 8 (4-19)
Prior stem-cell transplantation, n (%) 70 (72.2) 87 (70.7) 52 (82.5)
Triple-class
Exposed,* n (%) 97 (100.0) 123 (100.0) 63 (100.0)
Refractory,† n (%) 94 (96.9) 119 (96.7) 61 (96.8)
Penta-drug
Exposed,‡ n (%) 74 (77.3) 87 (70.7) 54 (85.7)
Refractory,§ n (%) 45 (46.4) 52 (42.3) 33 (52.4)
Prior pomalidomide therapy, n (%) 82 (84.5) 100 (81.3) 61 (96.8)
Prior carfilzomib therapy, n (%) 77 (79.4) 93 (75.3) 56 (88.9)
Prior BCMA-directed therapy
ADC therapy, n (%) 0 (0) 0 (0) 46 (73)
CAR T-cell therapy, n (%) 0 (0) 0 (0) 20 (31.7)
ADC and CAR T-cell therapy, n (%) 0 (0) 0 (0) 3 (4.8)||
Anti-BCMA bispecific therapy, n (%) 0 (0) 0 (0) 1 (1.6)

 

 Efficacy Population: BCMA-naïve 
(n=97)
Time since initial diagnosis (months), median 79.6
Prior lines of therapy, median (range) 5.0 (4-22)
Prior stem-cell transplantation, n (%) 70 (72.2)
Triple-class
Exposed,* n (%) 97 (100.0)
Refractory,† n (%) 94 (96.9)
Penta-drug,
Exposed,‡ n (%) 75 (77.3)
Refractory,§ n (%) 45 (46.4)
Prior pomalidomide therapy, n (%) 82 (84.5)
Prior carfilzomib therapy, n (%) 77 (79.4)
Prior BCMA-directed therapy
ADC therapy, n (%) 0 (0)
CAR T-cell therapy, n (%) 0 (0)
ADC and CAR T-cell therapy, n (%) 0 (0)
Anti-BCMA bispecific therapy, n (%) 0 (0)
  Enrolled Population: BCMA-naïve (N=123)
Time since initial diagnosis (months), median 72.9
Prior lines of therapy, median (range) 5.0 (2-22)
Prior stem-cell transplantation, n (%) 87 (70.7)
Triple-class
Exposed,* n (%) 123 (100.0)
Refractory,† n (%) 119 (96.7)
Penta-drug
Exposed,‡ n (%) 87 (70.7)
Refractory,§ n (%) 52 (42.3)
Prior pomalidomide therapy, n (%) 100 (81.3)
Prior carfilzomib therapy, n (%) 93 (75.6)
Prior BCMA-directed therapy
ADC therapy, n (%) 0 (0)
CAR T-cell therapy, n (%) 0 (0)
ADC and CAR T-cell therapy, n (%) 0 (0)
Anti-BCMA bispecific therapy, n (%) 0 (0)
  Cohort B: BCMA-exposed (n=63)
Time since initial diagnosis (months), median 103.0
Prior lines of therapy, median (range) 8 (4-19)
Prior stem-cell transplantation, n (%) 52 (82.5)
Triple-class
Exposed,* n (%) 63 (100.0)
Refractory,† n (%) 61 (96.8)
Penta-drug
Exposed,‡ n (%) 54 (85.7)
Refractory,§ n (%) 33 (52.4)
Prior pomalidomide therapy, n (%) 61 (96.8)
Prior carfilzomib therapy, n (%) 56 (88.9)
Prior BCMA-directed therapy
ADC therapy, n (%) 46 (73)
CAR T-cell therapy, n (%) 20 (31.7)
ADC and CAR T-cell therapy, n (%) 3 (4.8)||
Anti-BCMA bispecific therapy, n (%) 1 (1.6)¶
Triple-class exposed refers to having received at least 1 PI, 1 IMiD, and 1 anti-CD38 mAb.2Triple-class refractory refers to refractory to at least 1 PI, 1 IMiD, and 1 anti-CD38 mAb.2Penta-drug exposed refers to having received at least 2 Pls, 2 IMiDs, and 1 anti-CD38 mAb.2Penta-drug refractory refers to refractory to at least 2 Pls, 2 IMiDs, and 1 anti-CD38 mAb.2Of the 66 patients who had received ADC therapy or CAR T-cell therapy, 3 received both.2Due to a protocol deviation, 1 patient who had prior treatment with a BCMA-directed bispecific was enrolled and included in the endpoint analysis.2Video Dr. Noa Biran discusses the MagnetisMM-3 study Watch nowLoadingADC=antibody-drug conjugate; BCMA=B-cell maturation antigen; BICR=Blinded Independent Central Review; CAR=chimeric antigen receptor; CD=cluster of differentiation; CrCl=creatinine clearance; ECOG=Eastern Cooperative Oncology Group; IMiD=immunomodulatory drug; mAb=monoclonal antibody; MM=multiple myeloma; PI=proteasome inhibitor; PS=performance status; R-ISS=Revised International Staging System; RRMM=relapsed or refractory multiple myeloma.Study Results: BCMA-naïveEfficacy results in patients without prior BCMA-directed therapy Explore more LoadingReferences:ELREXFIO Prescribing Information. New York, NY: Pfizer Inc.Data on file. Pfizer Inc., New York, NY.
Efficacy Warnings, precautions, and most common adverse reactions seen with ELREXFIO Safety Review safety data Loading ELREXFIO is available
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INDICATION AND USAGEELREXFIO™ (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).
Important Safety InformationWARNING: 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