Pfizer’s ELREXFIO Significantly Improves Progression-Free Survival for Double-Class Exposed Patients with Relapsed or Refractory Multiple Myeloma

Key Terms

progression-free survival medical

Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.

blinded independent central review medical

Blinded independent central review is a quality-control step in clinical trials where outside medical experts, who do not know which patients received the experimental therapy, re-examine key measurements (like scans or lab results) to prevent bias. Think of it as neutral referees watching game footage without knowing the teams, which gives investors greater confidence that the trial results are fair, more reliable for regulators, and less likely to be overturned or disputed.

hazard ratio medical

A hazard ratio is a way scientists compare the chance of something happening over time between two groups, like patients taking different medicines. If the ratio is high, it means one group is more likely to experience the event sooner or more often, which helps determine how effective a treatment is or how risky a situation might be.

overall survival medical

Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.

multiple myeloma medical

A cancer of the blood that starts in plasma cells, the immune system’s antibody-producing cells in bone marrow. It behaves like a factory where the workers go rogue, crowding out healthy cells and causing bone damage, anemia and infections; treatments and trial results can sharply affect drug sales, regulatory approvals and company valuations, so progress or setbacks are closely watched by investors.

accelerated approval regulatory

Accelerated approval is a process that allows new medical treatments to be approved more quickly than usual if they address serious or life-threatening conditions and show promising early results. For investors, it signals that a treatment may reach the market sooner, potentially boosting a company's prospects, but it also involves some uncertainty since full evidence of effectiveness is still being gathered.

conditional marketing authorization regulatory

A conditional marketing authorization is a limited, temporary approval from a drug regulator that lets a medicine or vaccine be sold based on earlier or smaller amounts of safety and effectiveness data than normally required, usually because the treatment addresses a serious unmet need. It matters to investors because it can allow a company to start generating revenue sooner—like a provisional driver’s license—while carrying higher regulatory and clinical risk if follow‑up studies fail or additional data are required.

standard-of-care medical

The standard-of-care is the widely accepted medical treatment or procedure that doctors typically use for a particular illness, based on current evidence and clinical practice. For investors it matters because new drugs or devices must beat or match this baseline to be adopted, reimbursed and widely sold—think of it as the default recipe a market expects; a new product must prove it’s tastier, cheaper, or faster to replace it.

• Primary endpoint met at the interim analysis in MagnetisMM-5 trial demonstrating a statistically significant and clinically meaningful improvement in progression-free survival
• Safety was consistent with the known ELREXFIO profile, with no new safety signals identified
• Trial remains ongoing to assess overall survival, a key secondary endpoint
• Interim efficacy results further strengthen confidence in development strategy for ELREXFIO as monotherapy and in combination, across multiple lines of therapy

NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) today announced positive topline results from the Phase 3 MagnetisMM-5 study evaluating ELREXFIO^® (elranatamab) as monotherapy in adults with relapsed or refractory multiple myeloma (RRMM) who received at least one prior line of treatment. The study demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression‑free survival (PFS), as assessed by blinded independent central review (BICR), versus standard-of-care daratumumab plus pomalidomide and dexamethasone (DPd). The safety and tolerability of ELREXFIO was consistent with its known safety profile.

The PFS results exceeded the pre-specified interim analysis target hazard ratio for efficacy, with most ELREXFIO-treated patients remaining progression-free. The trial remains ongoing to assess overall survival, a key secondary endpoint, which was not yet mature at the time of this interim analysis. These data will be discussed with global health authorities, and detailed results from MagnetisMM-5 will be submitted for presentation at a future medical congress.

Multiple myeloma is an aggressive and currently incurable blood cancer that affects plasma cells made in the bone marrow:

• It is the second most common type of blood cancer worldwide, with over 36,000 new cases each year in the United States and over 187,000 globally.^1,2,3
• Despite treatment advances, most patients relapse and develop relapsed or refractory disease, often requiring multiple lines of therapy, with approximately 40% not surviving beyond five years.^2,4
• Multiple myeloma can significantly impact quality of life, with immune suppression increasing susceptibility to infection, and symptoms such as fatigue, bone pain, and psychological distress making everyday activities more difficult.^5-7

“Effective intervention earlier in the course of disease represents a critical opportunity to improve outcomes for people living with multiple myeloma,” said Jeff Legos, Chief Oncology Officer, Pfizer. “ELREXFIO has already helped address a significant unmet need in heavily pre‑treated patients, delivering deep, durable, and clinically meaningful responses. The MagnetisMM-5 results reinforce our confidence in ELREXFIO’s potential to benefit patients earlier in their treatment journey and support our comprehensive strategy to evaluate ELREXFIO both as monotherapy and as part of combination approaches across multiple lines of therapy.”

ELREXFIO is approved in more than 35 countries worldwide, including in the United States where it received accelerated approval for use in adults with RRMM who have received at least four prior lines of therapy, and in the European Union where it was granted conditional marketing authorization for adults with RRMM who have received at least three prior therapies and have demonstrated disease progression on the last therapy.

MagnetisMM-5 is part of a comprehensive development program in double-class exposed MM patients. The program includes the fully recruited Phase 3 MagnetisMM-32 study, which is designed to evaluate ELREXFIO in patients who have previously received daratumumab as part of standard-of-care front-line MM treatment.

About Multiple Myeloma
Multiple myeloma is an aggressive and currently incurable blood cancer that affects plasma cells made in the bone marrow. Healthy plasma cells make antibodies that help the body fight infection.⁶ While disease trajectory varies for each person, relapses are nearly inevitable.⁹ The goal of therapy for people with relapsing or refractory multiple myeloma is to achieve disease control with acceptable toxicity and improved quality of life.¹⁰

About MagnetisMM-5
MagnetisMM-5 is an open-label, multicenter, randomized Phase 3 study to evaluate the efficacy and safety of ELREXFIO versus standard-of-care daratumumab plus oral pomalidomide and dexamethasone in patients with RRMM. The study enrolled 497 patients across 26 countries who have received at least one line of previous treatment, including lenalidomide and a proteasome inhibitor (PI). Participants received subcutaneous ELREXFIO as two step-up priming doses followed by a weekly 76 mg injection, with frequency adjusted to every two weeks after 24 weeks if a partial response was achieved for more than two months, and again to every four weeks for all patients after 48 weeks on treatment. The primary endpoint is progression-free survival (PFS), as assessed by blinded independent central review (BICR). A key secondary endpoint is overall survival.

Pfizer continues to evaluate ELREXFIO both as a monotherapy and as a combination regimen as part of the MagnetisMM clinical trial program.

About ELREXFIO (elranatamab)
ELREXFIO is a subcutaneously delivered B-cell maturation antigen (BCMA)-cluster of differentiation CD3-directed bispecific antibody immunotherapy that binds to BCMA on myeloma cells and CD3 on T cells, activating the T cells to kill myeloma cells.

U.S. Important Safety Information and Indication

ELREXFIO may cause side effects that are serious, life-threatening, or can lead to death, including cytokine release syndrome (CRS) and neurologic problems. CRS is common during treatment with ELREXFIO.

Tell your healthcare provider or get medical help right away if you develop any signs or symptoms of CRS or neurologic problems, including:

fever of 100.4°F (38°C) or higher trouble breathing chills dizziness or light-headedness fast heartbeat headache increased liver enzymes in your blood

agitation, trouble staying awake, confusion or disorientation, or seeing or hearing things that are not real (hallucinations) trouble speaking, thinking, remembering things, paying attention, or understanding things

problems walking, muscle weakness, shaking (tremors), loss of balance, or muscle spasms numbness and tingling (feeling like “pins and needles”) burning, throbbing, or stabbing pain changes in your handwriting

Due to the risk of CRS, you will receive ELREXFIO on a “step-up” dosing schedule and should be hospitalized for 48 hours after the first “step-up” dose and for 24 hours after the second “step-up” dose of ELREXFIO.

• For your first dose, you will receive a smaller “step-up” dose of ELREXFIO on day 1
• For your second dose, you will receive a larger “step-up” dose of ELREXFIO, which is usually given on day 4 of treatment
• For your third dose, you will receive the first “treatment” dose of ELREXFIO, which is usually given on day 8

If your dose of ELREXFIO is delayed for any reason, you may need to repeat step-up dosing. Before each dose of ELREXFIO during the step-up dosing schedule, you will receive medicines to help reduce your risk of CRS. Your healthcare provider will decide if you need to receive medicines to help reduce your risk of CRS with future doses.

ELREXFIO is available only through the ELREXFIO Risk Evaluation and Mitigation Strategy (REMS) Program due to the risk of CRS and neurologic problems. You will receive an ELREXFIO Patient Wallet Card from your healthcare provider. Carry the ELREXFIO Patient Wallet Card with you at all times and show it to all of your healthcare providers. The ELREXFIO Patient Wallet Card lists signs and symptoms of CRS and neurologic problems. Get medical help right away if you develop any of the signs and symptoms listed on the ELREXFIO Patient Wallet Card. You may need to be treated in a hospital.

Before taking ELREXFIO, tell your healthcare provider about all of your medical conditions, including if you:

• have an infection
• are pregnant or plan to become pregnant. ELREXFIO may harm your unborn baby. Females who are able to become pregnant should do a pregnancy test before starting treatment with ELREXFIO and should use effective birth control during treatment and for four months after your last dose of ELREXFIO. Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with ELREXFIO
• are breastfeeding or plan to breastfeed. It is not known if ELREXFIO passes into your breast milk. Do not breastfeed during treatment and for four months after your last dose of ELREXFIO

Tell your healthcare provider about all of the medications you take, including prescription and over-the-counter medications, vitamins, and herbal supplements.

Do not drive, operate heavy or potentially dangerous machinery, or do other dangerous activities during treatment with ELREXFIO:

• for 48 hours after completing each of the 2 doses of ELREXFIO that are part of the “step-up dosing schedule” and your first full treatment dose, and
• at any time during treatment with ELREXFIO if you develop any new neurologic symptoms, such as dizziness, confusion, shaking (tremors), sleepiness, or any other symptom that impairs consciousness, until the symptoms go away

Infections: Upper respiratory tract infection and pneumonia are common during treatment with ELREXFIO. ELREXFIO can cause bacterial and viral infections that are severe, life-threatening, or that may lead to death.

• Your healthcare provider may prescribe medications for you to help prevent infections and treat you as needed if you develop an infection during treatment with ELREXFIO
• Tell your healthcare provider right away if you develop any signs or symptoms of an infection during treatment with ELREXFIO, including: fever of 100.4°F (38°C) or higher, chills, cough, shortness of breath, chest pain, sore throat, pain during urination, or feeling weak or generally unwell
• People with active infections should not start ELREXFIO

Decreased white blood cell counts: Decreased white blood cell counts are common during treatment with ELREXFIO and can also be severe. A fever can occur with low white blood cell counts and may be a sign that you have an infection. Your healthcare provider will treat you as needed.

Liver problems: ELREXFIO can cause increased liver enzymes and bilirubin in your blood. These increases can happen with or without you also having CRS. Tell your healthcare provider if you develop any of the following signs or symptoms of a liver problem, including:

tiredness loss of appetite pain in your right upper stomach-area

dark urine yellowing of your skin or the white part of your eyes

The most common side effects of ELREXFIO include:

tiredness injection site reaction, such as redness, itching, pain, bruising, rash, swelling, and tenderness

diarrhea muscle and bone pain decreased appetite

rash cough nausea fever

The most common severe abnormal lab test results with ELREXFIO include decreased white blood cells, red blood cells, and platelets.

Your healthcare provider may temporarily or permanently stop ELREXFIO if you have any of the side effects listed and they are severe. These are not all of the possible side effects of ELREXFIO.

Call your healthcare provider for medical advice about side effects. You may report side effects to the U.S. Food and Drug Administration (FDA) at 1-800-FDA-1088.

What is ELREXFIO?

ELREXFIO is a prescription medication used to treat adults with multiple myeloma who:

• have already received at least 4 treatment regimens, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, to treat their multiple myeloma, and
• their cancer has come back or did not respond to prior treatment

ELREXFIO was approved based on patient responses and durability of response. There are ongoing studies to confirm its clinical benefit. It is not known if ELREXFIO is safe and effective in children.

Please read full Prescribing Information, including BOXED WARNING, for ELREXFIO.

About Pfizer Oncology
At Pfizer Oncology, we are at the forefront of a new era in cancer care. Our industry-leading portfolio and extensive pipeline includes three core mechanisms of action to attack cancer from multiple angles, including small molecules, antibody-drug conjugates (ADCs), and multispecific antibodies, including other immune-oncology biologics. We are focused on delivering transformative therapies in some of the world’s most common cancers, including breast cancer, gastrointestinal cancer, genitourinary cancer, hematology-oncology, and thoracic cancers, which includes lung cancer. Driven by science, we are committed to accelerating breakthroughs to help people with cancer live better and longer lives.

About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

Pfizer Disclosure Notice
The information contained in this release is as of April 29, 2026. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about Pfizer Oncology, ELREXFIO ® (elranatamab), including its potential benefits, the development program for ELREXFIO, the MagnetisMM-5 results, and plans to share the results with global health authorities for potential regulatory submissions, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of ELREXFIO; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; whether the MagnetisMM-5 trial will meet the key secondary endpoint for overall survival; the risks associated with initial, preliminary or interim data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when applications for ELREXFIO may be filed in particular jurisdictions for any potential indications; whether and when any such applications for ELREXFIO that may be pending or filed may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether ELREXFIO will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of ELREXFIO; risks and uncertainties related to issued or future executive orders or other new, or changes in, laws or regulations; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

REFERENCES

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Source: Pfizer Inc.