Pfizer is hoping for earlier use of Elrexfio (elranatamab) in relapsed or refractory multiple myeloma (RRMM) after the drug showed benefit as a second-line therapy in a Phase III trial.
In the MagnetisMM-5 study (NCT05020236), Elrexfio as a monotherapy 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 Johnson & Johnson’s (J&J) Darzalex (daratumumab) plus pomalidomide and dexamethasone (DPd).
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The PFS results exceeded the pre-specified interim analysis target, with most Elrexfio patients remaining progression-free. The trial remains ongoing to assess overall survival (OS), a key secondary endpoint, which is not yet mature.
The study enrolled an estimated 944 adult patients with RRMM who had already received at least one prior line of treatment.
The safety and tolerability of Elrexfio were consistent with its known safety profile.
Jeff Legos, chief oncology officer at Pfizer, said: “Effective intervention earlier in the course of disease represents a critical opportunity to improve outcomes for people living with multiple myeloma. 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.”
Pfizer will discuss the MagnetisMM-5 data with global health authorities, and detailed results will be submitted for presentation at a future medical congress.
Elrexfio, a subcutaneous bispecific antibody, is approved in more than 35 countries worldwide, including in the US 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 (EU) where it was granted conditional marketing authorisation for adults with RRMM who have received at least three prior therapies and have demonstrated disease progression on the last therapy.
MM is the second most common type of blood cancer worldwide, with over 36,000 new cases each year in the US and over 187,000 globally. 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.
GlobalData’s ‘Multiple Myeloma: Eight-Market Drug Forecast 2022–32’ report forecasted that in 2026, there will be $25.5bn of sales, increasing to $29.9bn by 2032, across the eight major markets (8MM: US, France, Germany, Italy, Spain, UK, Japan, and China). This is led by monoclonal antibodies, immunomodulatory drugs, and chimeric antigen receptor T-cell (CAR-T) therapies.
As per the analysis, total market sales will see a distribution shift towards the second line of therapy or later with the approvals of J&J’s Carvykti (ciltacabtagene autoleucel) and Tecvayli (teclistamab-cqyv) in 2022, and as patents for first-line and maintenance therapies, BMS’s Revlimid (lenalidomide) and J&J’s Darzalex expire in 2027 and 2029, respectively.
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