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In the single-arm, Phase 2 MagnetisMM-3 study

ELREXFIO delivered deep (≥VGPR) and durable responses2,3Objective response in BCMA-directed therapy–naïve patients (primary endpoint)

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

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

Among responding patients, the DoR rate at 9 months was 82.3%.

Most common adverse reactions2,†

The most common adverse reactions (≥20%) were CRS (58%), fatigue (43%), injection-site reaction (37%), diarrhea (36%), upper respiratory tract infection (34%), musculoskeletal pain (34%), pneumonia (32%), decreased appetite (26%), rash (25%), cough (24%), nausea (22%), and pyrexia (21%).

The most common Grade 3/4 laboratory abnormalities (≥30%) were decreased lymphocytes (84%), decreased neutrophils (51%), decreased hemoglobin (43%), decreased white blood cells (40%), and decreased platelets (32%).

Study design: MagnetisMM-3 was an open-label, single-arm, non-randomized, multicenter, Phase 2 study in 187 adult patients with RRMM refractory to at least 1 PI, 1 IMiD, and 1 anti-CD38 mAb. Of these patients, 183 received the recommended dosing regimen, and after 2 step-up doses of ELREXFIO, received 76 mg once weekly for Weeks 2 through 24, reduced to once every 2 weeks if a partial response or better was achieved and persisted for ≥2 months. The primary endpoint was ORR as assessed by BICR per IMWG criteria.2,3

ELREXFIO offers patients the convenience of subcutaneous administration and off-the-shelf availability2

Available off-the-shelf2

Rapid subcutaneous injection2,4

After Week 24, dosing can be reduced to every 2 weeks in responding patients2,‡

Ready-to-use, single-dose vial2

Fixed dose, with no weight-based calculations2

ELREXFIO is intended for subcutaneous use by a healthcare provider only, with adequate medical personnel and appropriate medical equipment to manage severe reactions, including CRS and neurologic toxicity, including ICANS.

Before starting ELREXFIO:

Premedication is recommended for both step-up doses (Days 1 and 4), as well as for the first treatment dose (Day 8), and is administered ~1 hour prior to ELREXFIO2:

  • Acetaminophen (or equivalent) 650 mg oral
  • Dexamethasone (or equivalent) 20 mg oral or IV
  • Diphenhydramine (or equivalent) 25 mg oral

Patients should continue treatment with ELREXFIO until disease progression or unacceptable toxicity.

ELREXFIO can be administered every 2 weeks after Week 24 in responding patients2,‡

*CR was achieved by 13.4% (13/97) of patients and sCR was achieved by 12.4% (12/97) of patients.3

†Safety population was comprised of the 183 patients (those with and without prior BCMA-directed therapy) who received the recommended step-up doses of 12 mg (Day 1) and 32 mg (Day 4).2

‡Patients who have received at least 24 weeks of treatment with ELREXFIO and have achieved a partial response or better and maintained this response for at least 2 months. Those patients who cannot switch to a dose frequency of every 2 weeks should continue weekly treatment.2

BCMA=B-cell maturation antigen; BICR=Blinded Independent Central Review; CD=cluster of differentiation; CR=complete response; CRS=cytokine release syndrome; DoR=duration of response; ICANS=immune effector cell-associated neurotoxicity syndrome; IMiD=immunomodulatory drug; IMWG=International Myeloma Working Group; IV=intravenous; mAb=monoclonal antibody; ORR=objective response rate; PI=proteasome inhibitor; PR=partial response; QW=once weekly; Q2W=once every 2 weeks; REMS=Risk Evaluation and Mitigation Strategy; sCR=stringent complete response; VGPR=very good partial response.

References: 1. 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 2. ELREXFIO Prescribing Information. New York, NY: Pfizer Inc. 3. Data on file. Pfizer Inc., New York, NY. 4. Kim H, Park H, Lee SJ. Effective method for drug injection into subcutaneous tissue. Sci Rep. 2017;7:9613. doi:10.1038/s41598-017-10110-w

INDICATION AND USAGE

IMPORTANT SAFETY INFORMATION

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).

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 System (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 the 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 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.