Pfizer said its Elrexfio treatment reduced the risk of disease progression or death in a Phase 3 study of adults with multiple myeloma treated earlier than the drug’s current U.S. indication allows.
The result concerns a treatment stage earlier than Elrexfio’s current U.S. indication. The drug is indicated for U.S. adults with relapsed or refractory multiple myeloma after at least four prior lines of therapy, including treatment from the proteasome-inhibitor, immunomodulatory-agent and anti-CD38-antibody classes.
Pfizer’s announcement said MagnetisMM-32 included 523 adults across 26 countries and used a randomized, open-label design. Patients had previously received lenalidomide and a CD38-targeting medicine; Pfizer named daratumumab and isatuximab as examples. Progression-free survival was the primary endpoint, assessed through blinded independent central review.
Pfizer said the prespecified interim efficacy analysis showed the study met its primary endpoint. More than 75% of patients who received Elrexfio were alive without disease progression. The estimated progression-free-survival rate at 18 months was 68%, and median progression-free survival had not been reached.
Pfizer said Elrexfio reduced the risk of progression or death compared with the control regimen. Investigators selected the control from three combinations: elotuzumab with pomalidomide and dexamethasone; pomalidomide with bortezomib and dexamethasone; or carfilzomib with dexamethasone.
Pfizer’s announcement reported grade 3 or higher infections in 27.5% of Elrexfio recipients and 18.1% of control patients. Grade 5 infection rates were 0.8% and 1.6%, respectively. Overall-survival data remain immature, Pfizer said, and patient follow-up is ongoing. The company plans to submit the findings to health authorities worldwide and present detailed results at a future medical meeting.
