Pfizer has announced findings from the Phase II MagnetisMM-3 clinical trial of ELREXFIO (elranatamab-bcmm) in patients with relapsed or refractory multiple myeloma (RRMM), who are heavily pretreated.

ELREXFIO is a B-cell maturation antigen (BCMA)-cluster of differentiation (CD)3-directed bispecific antibody immunotherapy delivered subcutaneously.

The non-randomised, open-label, multicentre trial assessed ELREXFIO monotherapy in patients who are refractory to a minimum of one proteasome inhibitor, immunomodulatory drug and anti-cluster of differentiation 38 antibody.

Two participant cohorts were evaluated, including those previously treated with BCMA-targeted therapies.

The study’s primary endpoint was the objective response rate (ORR), with key secondary outcomes including duration of response and safety.

According to the findings, a median overall survival of 24.6 months was reported in cohort A of the single arm trial.

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The trial showcased an ORR of 61% and a complete response rate of 37.4%, with a median duration of response not yet reached.

At the two-year mark, the estimated duration of response rate stood at 66.9% for all responders, and 87.9% for those with a complete response or better.

The median progression-free survival (PFS) was recorded at 17.2 months, with the two-year estimated PFS rate for patients with a complete response or better at 90.6%.

ELREXFIO’s safety profile in the trial was consistent with previous observations.

It obtained accelerated approval from the US Food and Drug Administration in August last year for treating RRMM in adults with at least four prior therapies.

Pfizer Oncology chief development officer Roger Dansey said: “These compelling overall survival data support the clinical benefit ELREXFIO has already demonstrated and its potential to be a transformative treatment option for people with multiple myeloma.

“The latest results from MagnetisMM-3 reinforce the very promising efficacy observed with ELREXFIO in a relapsed or refractory setting, with deep and durable responses, and although definitive conclusions cannot be drawn across studies, the longest reported median progression-free survival among B-cell maturation antigen bispecific antibodies.”