New Clinical Data at ASCO Reveals Deep and Durable Response to Elranatamab

• 13 abstracts across the comprehensive MagnetisMM clinical trial program reinforce the safety and efficacy profile of elranatamab among patients with heavily pretreated multiple myeloma

NEW YORK, NY, JUNE 3, 2023 – Pfizer Inc. (NYSE:PFE) announced today updated data from the MagnetisMM clinical development program that continue to show the emerging positive clinical profile of elranatamab, currently being investigated in multiple myeloma (MM). Data will be shared across 13 abstracts at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, including one oral and seven poster presentations. Notably, Phase 2 MagnetisMM-3 clinical trial data from patients with relapsed or refractory multiple myeloma (RRMM) who were previously treated with B-cell maturation antigen (BCMA)-directed therapy will be shared for the first time at ASCO, supporting the safety and efficacy of elranatamab regardless of prior BCMA-directed treatment history. Additional presentations include new 15-month data from BCMA-naïve patients, subgroup analyses among difficult-to-treat patient populations, real-world treatment patterns for triple-class refractory MM, and indirect comparisons/comparative effectiveness between elranatamab and other therapies.

“Relapse of multiple myeloma is unfortunately inevitable in most patients and can make later-line treatment decisions difficult given the heterogeneity of the disease. Given this challenge, the encouraging results presented at ASCO are particularly compelling,” said lead investigator Ajay Nooka, MD, MPH, Director of the Multiple Myeloma Program at Winship Cancer Institute of Emory University. “This population of heavily pretreated patients sets a high bar for efficacy and safety, and the current data coupled with its convenient subcutaneous dosing suggest elranatamab, if approved, could provide a much-needed new treatment option for these difficult-to-treat patients.”

With a median follow up of 11.3 months, RRMM patients previously treated with BCMA-directed therapy (n=87) – either in the form of CAR-T cell therapy or as an antibody-drug conjugate – achieved an objective response rate of 46% with elranatamab, which is an investigational BCMA-CD3-directed bispecific antibody (BsAb). Median time to objective response was 1.7 months. These data were shared as an oral presentation (abstract 8008) and are based on interim data from Cohort B of MagnestiMM-3 (NCT04649359) pooled together with data from BCMA-pretreated patients enrolled in MagnetisMM-1 (NCT03269136), MagnetisMM-2 (NCT04798586), and MagnetisMM-9 (NCT05014412). In addition to receiving prior BCMA-directed therapy, these patients were also previously treated with other classes of therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Although not all of the patients in this pooled data set received the recommended step-up priming dose regimen, the majority of cytokine release syndrome (CRS) cases were Grade 1 or 2, with 2.3% of participants experiencing a Grade 3 event. 

Additionally, 15-month Cohort A data from MagnetisMM-3 provides the longest-term data to date for elranatamab, suggesting deep and durable responses for patients who received elranatamab as their first BCMA-directed therapy (abstract 8039). With a median follow up of 14.7 months (n=123), objective response rate was 61.0%, and 35.0% had a complete response or better. Median duration of response was still not reached, with a 71.5% probability of maintaining the response at 15 months. Median progression-free survival and overall survival have not yet been reached. New data also show that roughly a third of the participants treated with elranatamab were able to switch to once-every-other-week dosing after achieving partial or better responses lasting at least two months, supporting the feasibility of less frequent dosing, which could have a positive impact on quality of life and overall long-term treatment tolerability. Previous 12-month results suggest elranatamab also has a manageable safety profile, with the two-step-up priming dose regimen helping to mitigate the rate and severity of CRS and immune effector cell-associated neurotoxicity syndrome (ICANS).

MagnetisMM-3 is part of the robust MagnetisMM clinical research program that expands to additional patient populations over time, with ongoing registration-intent trials exploring elranatamab both as a monotherapy and in combination with standard or novel therapies, spanning multiple patient populations from newly diagnosed MM to RRMM. This includes the registration-intent Phase 3 MagnetisMM-5 trial (NCT05020236) in the double-class exposed setting, MagnetisMM-6 (NCT05623020) in transplant-ineligible newly diagnosed patients, and MagnetisMM-7 (NCT05317416) with elranatamab as maintenance treatment in newly diagnosed patients after transplant, all of which are currently enrolling. 

"Based on the compelling data observed for elranatamab, we are continuing to progress and expand the MagnetisMM clinical development program to reach a rapidly growing number of patients globally across the treatment paradigm,” said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology and Rare Disease, Pfizer Global Product Development. “We are excited to share these latest data at ASCO, underscoring the early and deep responses, manageable safety profile, and dosing convenience of elranatamab, as well as its potential to be a transformative treatment for patients with multiple myeloma.” 

Additional data shared at ASCO include:

• Cohort A data from the MagnetisMM-3 trial (n=123) broken down by age and frailty support elranatamab as a potential option for older or more frail patients who may be ineligible for intensive treatments (abstract 8040). 
• Data from high-risk patients in Cohort A (n=123), including people with later-stage MM and resistance to at least five prior treatments, support favorable safety and efficacy of elranatamab in this difficult-to-treat population (abstract e20017). 
• A comparison of data from Cohort A (n=123) against real-world electronic health record data from MM patients with similar demographics and health history (n=385, NCT05565391) shows that the objective response rate for elranatamab was substantially higher than for MM treatments currently used in widespread clinical practice, including proteosome inhibitors, immunomodulatory drugs, and monoclonal antibodies (abstract 6618).

About Elranatamab
Elranatamab is an investigational, off-the-shelf, humanized BCMA-CD3-directed BsAb. BsAbs are a novel form of cancer immunotherapy that bind to and engage two different targets. One arm binds directly to specific antigens on cancer cells and the other arm binds to T-cells, bringing both cell types together. The binding affinity of elranatamab for BCMA and CD3 has been engineered to elicit potent T-cell-mediated anti-myeloma activity.  

Elranatamab is under review by regulatory agencies, including the U.S. Food and Drug Administration (FDA), which has granted Priority Review for its Biologics License Application (BLA) in RRMM and has accepted elranatamab for Project Orbis, a framework for the concurrent submission and review of oncology products to potentially expedite approvals in certain countries outside of the U.S. Additionally, the European Medicines Agency (EMA) is reviewing a marketing authorization application (MAA) for elranatamab under the PRIME scheme. The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has also granted elranatamab Innovative Medicine Designation and the Innovation Passport for the treatment of MM.

About MagnetisMM-3
MagnetisMM-3 (NCT04649359) is an ongoing, open-label, multicenter, single-arm, Phase 2 study designed to evaluate the safety and efficacy of elranatamab monotherapy in patients with RRMM. Patients receive subcutaneous (SC) elranatamab 76 mg weekly (QW) on a 28-day cycle with a step-up priming dose regimen, wherein 12 mg and 32 mg are administered on Day 1 and Day 4, respectively, during Cycle 1. For patients receiving six or more cycles and achieving a partial response or better for at least two months, the dosing interval is once every two weeks (Q2W).

About Multiple Myeloma
MM is a blood cancer that affects plasma cells in the bone marrow. Healthy plasma cells make antibodies that help the body fight infection. There are over 35,000 new cases of MM diagnosed annually in the U.S. and 176,000 globally.^1,2  Despite treatment advances, there is currently no cure. The median survival is just over five years, and most patients receive four or more lines of therapy.³

About Pfizer in Hematology
At Pfizer, we have an industry-leading portfolio of 24 approved innovative cancer medicines and biosimilars, including seven therapies to treat hematologic malignancies. We have taken bold new approaches over the past decade to translate scientific research into transformative medicines for people living with blood cancer. For the millions living with blood cancer today and for those diagnosed tomorrow, we work tirelessly to deliver on our mission: Breakthroughs that change patients’ 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 more than 170 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 Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

DISCLOSURE NOTICE: The information contained in this release is as of June 3, 2023. 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 elranatamab, an investigational B-cell maturation antigen (BCMA) CD3-directed bispecific antibody, including its potential benefits, 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, 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; risks associated with interim data, including the risk that additional data from MagnetisMM-3 could differ from the data discussed in this release; 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 drug applications for any potential indications for elranatamab may be filed in any other jurisdictions; whether and when the FDA and EMA may approve the pending applications for elranatamab for the treatment of people with RRMM and whether and when regulatory authorities in any jurisdictions may approve any such other applications that may be pending or filed for elranatamab, 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 elranatamab 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 elranatamab; 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, 2022 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.

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¹ American Cancer Society. Multiple Myeloma. Available at: https://www.cancer.org/cancer/multiple-myeloma/about/key-statistics.html. Accessed February 20, 2023.

² World Health Organization. Globocan 2020: Multiple Myeloma. Available at: https://gco.iarc.fr/today/data/factsheets/cancers/35-Multiple-myeloma-fact-sheet.pdf. Accessed February 20, 2023.

³ Mikhael, J, Ismaila N, Cheung M, et al. Treatment of multiple myeloma: ASCO and CCO joint clinical practice guideline. J Clin Oncol. 37:1228-1263

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