Pfizer has discovered a new drug, elranatamab for the treatment of people with Relapsed or Refractory Multiple Myeloma (RRMM).
Elranatamab is a B-cell maturation antigen (BCMA)-CD3-targeted bispecific antibody (BsAb).
BCMA, which is widely expressed on the surface of MM, was the target of elranatamab's development. T-cells interact with and become activated by the CD3 receptor on their surface, killing myeloma cells.
The binding affinity of elranatamab for BCMA and CD3 has been engineered to elicit potent T-cell mediated anti-myeloma activity.
BsAbs are defined as a novel form of cancer immunotherapy that bind to and engage 2 different targets at once, and as one arm binds directly to specific antigens on cancer cells, the other arm binds to T-cells and brings both cell types together. The bsAb is delivered subcutaneously, which is more convenient than intravenous administration and may mitigate the risk of potential adverse events, such as cytokine release syndrome (CRS).
The Breakthrough Therapy Designation was based on findings from a 6-month follow-up of cohort A of MagnetisMM-3, a multicenter, phase 2 trial analyzing the safety and efficacy of elranatamab monotherapy in patients with RRMM. Patients received subcutaneous (SC) elranatamab 76 mg weekly with a 2-step-up priming dose regimen administered during the first week.
The study found that elranatamab had a manageable safety profile. The most common treatment-emergent adverse event regardless of causality was CRS, with most cases being either grade 1 or grade 2.
Elranatamab is being studied both as a monotherapy and in conjunction with traditional or novel medicines in several patient populations, including those with newly diagnosed MM, double-class exposed illness, and RRMM. MagnetisMM-3 is a component of the MagnetisMM clinical research programme.
Elranatamab has also been granted Orphan Drug Designation by the FDA and the European Medicines Agency for the treatment of MM.