Pfizer Announces FDA Accelerated Approval of ELREXFIO (elranatamab), a BCMAxCD3 Bispecific Antibody, for Relapsed or Refractory Multiple Myeloma

On August 14, Pfizer announced that its CD3/BCMA bispecific antibody ELREXFIO (elranatamab) had received accelerated FDA approval for marketing. It is used to treat relapsed or refractory multiple myeloma (R/R MM) in patients who have previously undergone at least four types of therapy, including proteasome inhibitors, immunomodulatory agents, and anti-CD38 monoclonal antibodies. This is the second CD3/BCMA bispecific antibody to receive FDA approval following Johnson & Johnson's Tecvayli (teclistamab-cqyv).

Elranatamab (PF-06863135) is a humanized bispecific antibody that can simultaneously target multiple myeloma (MM) cells expressing B-cell maturation antigen (BCMA) and T cells expressing CD3.

This approval is based on the positive data from Cohort A of the MagnetisMM-3 (NCT04649359) study. The study is an open-label, multi-center, single-arm Phase II trial designed to evaluate the safety and efficacy of elranatamab monotherapy in patients with R/R MM. Cohort A enrolled 123 patients with R/R MM who were refractory to at least one proteasome inhibitor (PI), one immunomodulatory drug (IMiD), and one anti-CD38 monoclonal antibody.

In this study, the overall response rate (ORR) was 58% in patients (n=97) who had received four or more prior lines of therapy before elranatamab treatment, with an estimated 82% of patients maintaining response for at least 9 months, and a median time to first response of 1.2 months. The study also established that for patients achieving a response after 24 weeks of weekly dosing, the dosing frequency could be adjusted to once every two weeks. ELREXFIO is also the first BCMA therapy approved in the U.S. with this dosing regimen, which implies shorter clinical treatment duration and potentially better long-term tolerability.

Long-term efficacy data for Cohort A (n=123), presented at the 2023 European Hematology Association meeting, showed that at a median follow-up of 10.4 months, patients receiving elranatamab as their first BCMA-targeted therapy had an ORR of 61% and a VGPR of 55%. At a median follow-up of 14.7 months, the median duration of response, overall survival, and progression-free survival had not yet been reached. The probability of maintaining a response at 15 months was 72% for responding patients. Additionally, elranatamab demonstrated manageable safety in the study. CRS occurred at rates of 43% and 24% for grades 1 or 2 after the first and second doses, respectively, while CRS rates were 6% and <1% after the third and fourth doses, respectively. The incidence of ICANS was 3%, all of which were grade 1 or 2.

The instructions also include data from Cohort B (n=64) of the MagnetisMM-3 study. In this cohort, 63 patients had previously received at least four lines of therapy, including BCMA-targeted treatments (CAR-T or ADC). After a median follow-up of 10.2 months, the ORR was 33%, with an estimated 84% of patients maintaining their response for at least 9 months.

In the CD3/BCMA bispecific antibody track, Regeneron's linvoseltamab has entered Phase III clinical trials; BeiGene/Amgen's AMG 420, Connaught Biologics' CM336, EpimAb Biotherapeutics' EMB-06, Regeneron's REGN5459, and AbbVie/Amgen's TNB-383B have all entered Phase I/II.

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