Multiple myeloma patients with heavily pretreated relapsed or refractory disease were the focus of Pfizer Inc.’s announcement detailing overall survival (OS) results from the Phase 2 MagnetisMM-3 study of ELREXFIO™ (elranatamab-bcmm). The study demonstrated a median OS of 24.6 months (95% CI, 13.4, NE) in cohort A (n=123) of the pivotal single-arm trial. “These compelling overall survival data support the clinical benefit ELREXFIO has already demonstrated and its potential to be a transformative treatment option for people with multiple myeloma,” said Roger Dansey, M.D., Chief Development Officer, Oncology, Pfizer.
The MagnetisMM-3 data will be presented during a poster session (#932) at the European Hematology Association (EHA) Hybrid Congress in Madrid, Spain, from June 13-16. Additional presentations at EHA 2024 will highlight ELREXFIO data across the comprehensive MagnetisMM clinical trial program.
The study results reinforce the efficacy of ELREXFIO in the relapsed or refractory setting, showcasing deep and durable responses. After more than two years of follow-up, the overall response rate (ORR) for patients on ELREXFIO was 61.0%, with a complete response rate (CRR) of 37.4%. Responses deepened over time, and the median duration of response (DOR) was not reached. At two years, the estimated DOR rate was 66.9% for all responders and 87.9% for patients with CR or better response. Median progression-free survival (PFS) was 17.2 months, and for patients with CR or better response, the median PFS was not reached, with an estimated two-year PFS rate of 90.6%.
Encouraging Survival Data for ELREXFIO™ in Advanced Multiple Myeloma Patients
“People with relapsed or refractory multiple myeloma often have limited therapeutic options as their disease progresses due to treatment resistance, resulting in increasingly shorter remission and duration of response,” said MagnetisMM-3 clinical trial investigator Mohamad Mohty, M.D., Ph.D., Professor of Hematology and Head of the Hematology and Cellular Therapy Department at the Saint-Antoine Hospital and Sorbonne University, Paris, France. “These impactful overall survival data are particularly encouraging given the very advanced patient population with characteristics associated with poorer outcomes.”
The safety profile of ELREXFIO in the MagnetisMM-3 study was consistent with previous observations. Five patients (4.1%) experienced secondary primary malignancies (SPMs), all cases being squamous cell carcinoma of the skin. No hematological SPMs were reported. Due to the risk of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), patients should be monitored for signs and symptoms for 48 hours after administration of each of the two step-up doses within the ELREXFIO dosing schedule and instructed to remain near a healthcare facility. In the EU, precautionary hospitalization is not required for the first treatment dose of 76 mg.
Based on the MagnetisMM-3 trial results, ELREXFIO received accelerated approval in August 2023 from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with RRMM who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody. Continued approval for this indication is contingent upon verification of clinical benefit in a confirmatory trial. In December 2023, the European Commission granted conditional marketing authorization for ELREXFIO for the treatment of adult patients with RRMM who have received at least three prior therapies and have demonstrated disease progression on the last therapy.
ELREXFIO Gains International Approvals and Expands Clinical Trials for Multiple Myeloma
ELREXFIO has also received approval in Switzerland, Brazil, and Canada under Project Orbis, which facilitates concurrent submission and review of oncology drugs among international partners to expedite approvals. Two other countries, Australia and Singapore, are participating in Project Orbis. The Medicines and Healthcare Products Regulatory Agency (MHRA) granted ELREXFIO authorization for Great Britain for RRMM.
Pfizer’s comprehensive MagnetisMM clinical development program is exploring the use of elranatamab across the entire spectrum of multiple myeloma (MM) patients, from relapsed or refractory MM (RRMM) to newly diagnosed MM. Ongoing registrational-intent trials include MagnetisMM-4, which investigates elranatamab with other anti-cancer therapies; MagnetisMM-5, focusing on the double-class exposed setting; MagnetisMM-6, targeting newly diagnosed patients ineligible for stem cell transplant; MagnetisMM-7, addressing newly diagnosed patients post-transplant; and MagnetisMM-32, investigating elranatamab in patients with prior anti-CD38-directed therapy.
Pfizer Inc. is a global biopharmaceutical company committed to discovering and developing innovative treatments to improve patient outcomes. With a broad portfolio of products and a robust pipeline, Pfizer aims to bring breakthroughs that change patients’ lives. The company’s global team of more than 10,000 colleagues spans five continents, working tirelessly to advance medical science and healthcare solutions.
The detailed overall survival results from the MagnetisMM-3 study highlight ELREXFIO’s potential as a transformative treatment for heavily pretreated relapsed or refractory multiple myeloma. With deep and durable responses, the therapy offers hope to patients with limited options. Pfizer’s ongoing commitment to advancing elranatamab through its comprehensive clinical development program further underscores the company’s dedication to improving outcomes for multiple myeloma patients globally.
Resource: Pfizer, June 14, 2024
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