Pfizer ELREXFIO Beats Standard of Care in Phase 3 Multiple Myeloma Trial as AbbVie Files for FDA Approval of Rival Drug

Pfizer reported that its bispecific antibody ELREXFIO (elranatamab) met the primary endpoint of progression-free survival in the Phase 3 MagnetisMM-32 trial, outperforming three established standard-of-care regimens in adults with relapsed or refractory multiple myeloma who had previously received anti-CD38 therapy and lenalidomide. The benefit was described as clinically meaningful and statistically significant, with median PFS not yet reached at the time of the pre-specified interim analysis. Grade 3 or higher infections were observed in 27.5% of elranatamab patients versus 18.1% on investigator's choice, though Grade 5 infection rates were lower in the ELREXFIO arm at 0.8% compared to 1.6% on standard regimens, and no new safety signals were identified.

The MagnetisMM-32 data are notable because they test elranatamab as a fixed-dose, off-the-shelf monotherapy against a rigorous set of clinical benchmarks in an earlier treatment line than the drug's current approved use, potentially supporting a label expansion into second-line-plus patients. On the same day, AbbVie submitted a Biologics License Application to the FDA seeking approval for etentamig, another bispecific antibody targeting relapsed or refractory multiple myeloma, intensifying competition in the space.

Elsewhere in oncology and gene therapy, Beam Therapeutics reported clinical proof of concept for BEAM-301, its in vivo base editing therapy for glycogen storage disease type Ia, showing restoration of endogenous glucose production following a single treatment with dose-dependent improvements in key disease endpoints at the ESGCT 33rd Annual Congress in Hamburg. Natera highlighted data from 25 abstracts at the ESMO Congress, including results from the Phase 3 VOLGA trial supporting its Signatera Genome technology for minimal residual disease-guided treatment in bladder cancer. Arrowhead Pharmaceuticals announced that plozasiran (REDEMPLO) is now available on the NHS in England and Wales for familial chylomicronaemia syndrome after receiving licensing approval for the rare lipid disorder.