Pfizer Announces European Commission Approval of ELREXFIO (elranatamab) for Relapsed or Refractory Multiple Myeloma

Dec 09, 2023 08:01 CST Updated 08:01

Pfizer

Pharmaceutical R&D Developer

On December 8, Pfizer announced that the European Commission (EC) had approved the CD3/BCMA bispecific antibody.ELREXFIO(Elranatamab) is launched,For the treatment of relapsed or refractory multiple myeloma (R/R MM)These patients have previously received at least three treatments, including proteasome inhibitors, immunomodulatory agents, and anti-CD38 monoclonal antibodies. In August this year, the product has been approved for marketing by the FDA.

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 MagnetisMM-3 (NCT04649359).Positive Data from Cohort A of the Study. This 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, among those receivingelranatamabReceived 4 or more lines of treatment before treatmentThe overall response rate (ORR) for the treated patients (n=97) was 58%, with an estimated 82% of patients maintaining their response for at least 9 months. The median time to first response was 1.2 months. The study also established thatPatients who achieved remission after 24 weeks of weekly dosing treatment, the dosing frequency can be adjusted to once every two weeks.ELREXFIO is also the first in the United States to be approved for this dosing regimen.BCMATherapy，This means shorter clinicalTreatment duration and potentially better long-term treatment tolerance.

Long-term efficacy data of Cohort A (n=123) presented at the 2023 European Hematology Association meetingShow that, at a median follow-up of 10.4 months, patients receiving elranatamab as their first BCMA-targetedThe ORR for patients receiving treatment was 61%, with VGPR at 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. For patients who achieved a response, the probability of maintaining the response at 15 months was 72%. Additionally, elranatamab demonstrated a manageable safety profile in the study. CRS occurred in 43% and 24% of patients after the first and second doses, respectively, with only grade 1 or 2 severity; the incidence of CRS following the third and fourth doses was 6% and <1%, 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), with a median follow-up of 10.2 months.ORRAt 33%, it was estimated that 84% of patients maintained remission for at least 9 months.

Welcome to forward, share, and reasonably cite. When citing, please clearly indicate the source of the article in a prominent position;For reprint, please leave a message or send a message to the WeChat Official Account backend, and indicate the name and ID of the official account.

Disclaimer: The information in this WeChat article is for general reference only and should not be used directly as decision-making content. PharmaCube assumes no responsibility for any loss incurred by any party due to the use of the content herein.

PharmaCube Reader Survey Questionnaire

Thank You for Your Support! We Look Forward to Your Feedback.

Scan the QR code to provide valuable suggestions