Study Design

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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)
	ITT 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	43 (68.3)
Black	2 (3.2)
Asian	1 (1.6)
Unknown/Not reported	17 (27.0)
Ethnicity, n (%)
Hispanic/Latino	7 (11.1)

	Efficacy Population: BCMA-naïve (n=97)	ITT 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)	ITT 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	20 (20.6)	28 (22.8)	11 (17.5)
II	52 (53.6)	68 (55.3)	35 (55.6)
III	17 (17.5)	19 (15.4)	15 (23.8)
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.²

Defined 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)
	ITT 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.²

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

Treatment history

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

Defined 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)	ITT 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 (%)	75 (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 (75.6)	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)
	ITT 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.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 Pls, 2 IMiDs, and 1 anti-CD38 mAb.²

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

Of the 66 patients who had received ADC therapy or CAR T-cell therapy, 3 received both.²

Due to a protocol deviation, 1 patient who had prior treatment with a BCMA-directed bispecific was enrolled and included in the endpoint analysis.²

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ADC=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; ITT=intent-to-treat; 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-naïve

Efficacy results in patients without 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.

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INDICATION AND USAGE

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).® (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).® (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).® (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 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.

Indication and Usage