RE:RE:RE:ONCY pelareorep + CD3 bispecific antibody true-killer comboNovember 03, 2022 - Pfizer's Elranatamab, a B-cell maturation antigen (BCMA)-CD3-targeted bispecific antibody (BsAb), received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of people with relapsed or refractory multiple myeloma (RRMM).
BsAbs are a novel form of cancer immunotherapy that bind to and engage two different targets at once. One arm binds directly to specific antigens on cancer cells and the other arm binds to T-cells, bringing both cell types together. Elranatamab is designed to bind to BCMA, which is highly expressed on the surface of multiple myeloma (MM) cells, and the CD3 receptor found on the surface of T-cells, bridging them together and activating the T-cells to kill the myeloma cells. The binding affinity of elranatamab for BCMA and CD3 has been engineered to elicit potent T-cell mediated anti-myeloma activity.
The Breakthrough Therapy Designation is based on six-month follow-up data from cohort A (n=123) of MagnetisMM-3, an open-label, multicenter, single arm, Phase 2 study evaluating the safety and efficacy of elranatamab monotherapy in patients with RRMM. Patients received subcutaneous (SC) elranatamab 76 mg weekly (QW) with a 2-step-up priming dose regimen administered during the first week.
The study showed elranatamab demonstrated a manageable safety profile, and at a median follow-up of 6.8 months, patients achieved an overall response rate (ORR) of 61.0%.
https://www.biospace.com/article/releases/pfizer-s-elranatamab-granted-fda-breakthrough-therapy-designation-for-relapsed-or-refractory-multiple-myeloma/