Updated favorable elranatamab data from pivotal phase II MagnetisMM-3 trial is presented at ASH.- Pfizer
Pfizer announced 10.4 month follow-up data from the pivotal Phase II MagnetisMM-3 clinical trial suggesting elranatamab, a B-cell maturation antigen (BCMA)-CD3-targeted bispecific antibody (BsAb), is efficacious and has a manageable safety profile in patients with relapsed or refractory multiple myeloma (RRMM) in a heavily pretreated population, who have received at least three classes of prior therapies including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody (i.e. triple-class refractory or exposed).
In this analysis, safety and efficacy were analyzed in 123 patients who had received at least one dose of elranatamab (cohort A – BCMA-naïve) as of the data cut-off on October 14, 2022. Patients received SC elranatamab 76 mg weekly (QW) on a 28-day cycle with a step-up priming dose regimen, 12 mg and 32 mg administered on Day 1 and Day 4, respectively, during Cycle 1.
With a median follow up of 10.4 months, patients who received elranatamab achieved a high objective response rate of 61%, with 84% probability of maintaining response at nine months. Probability of progression-free survival and overall survival were 63% and 70%, respectively, at nine months. The results also suggest elranatamab has a manageable safety profile and that the two-step-up priming dose regimen (12/32 mg) mitigated the rate and severity of cytokine release syndrome (CRS) (58%, all Grade 1/2) and immune effector cell-associated neurotoxicity syndrome (ICANS, 3%, all Grade 1/2) in cohort A of MagnetisMM-3 (n=119).
The most common hematologic treatment emergent adverse events (TEAEs) of any grade were – anemia (48%), neutropenia (48%), thrombocytopenia (30%) and lymphopenia (26%). These data are being presented in an oral session at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition 2022 (abstract 159).
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