Posted: Monday, November 7, 2022
On November 3, Pfizer announced its investigational cancer immunotherapy, elranatamab, received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of relapsed or refractory multiple myeloma. In addition, elranatamab has been granted Orphan Drug designation by the FDA and the European Medicines Agency (EMA) for the treatment of multiple myeloma. Elranatamab is a B-cell maturation antigen (BCMA)-CD3–targeted bispecific antibody.
The Breakthrough Therapy designation is based on 6-month follow-up data from cohort A (n = 123) of the phase II MagnetisMM-3 trial. This open-label, multicenter, single-arm study is evaluating the safety and efficacy of elranatamab monotherapy in patients with resistant myeloma. Patients received subcutaneous elranatamab at 76 mg weekly with a two step-up priming dose regimen administered during the first week.
In the study, elranatamab demonstrated a manageable safety profile. And, at a median follow-up of 6.8 months, patients achieved an overall response rate of 61%. Among responders, there was a 90.4% probability of maintaining a response of at least 6 months.
The most common treatment-emergent adverse event regardless of causality was cytokine-release syndrome (57.9%), with many of the events reported being either grade 1 (43.2%) or grade 2 (14.2%). Updated data from MagnetisMM-3 will be presented at the 2022 American Society of Hematology (ASH) Annual Meeting and Exposition in December in New Orleans.