Elranatamab Receives Accelerated Approval in R/R Multiple Myeloma

Data from the phase 2 MagnetisMM-3 trial (NCT04649359) support the FDA's approval of elranatamab-bcmm as a treatment for adult patients with previously treated relapsed/refractory multiple myeloma.

The FDA has granted accelerated approval to elranatamab-bcmm (Elrexfio) for patients with relapsed/refractory multiple myeloma who have received at least 4 prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, according to a press release from Pfizer.¹

The approval is based on results from part A of the single-arm phase 2 MagnetisMM-3 trial (NCT04649359) and is dependent upon verification of clinical benefit in a confirmatory trial.¹ Among 97 evaluable patients, the overall response rate (ORR) was 58%, and approximately 82% of patients had responses lasting for at least 9 months. Investigators reported a median time to first response of 1.2 months.

“[Elranatamab] reflects our ongoing commitment to developing scientific breakthroughs that meaningfully improve outcomes for people with cancer…With significant responses in a patient population with highly refractory disease, we believe [elranatamab] is poised to potentially become the new standard of care for multiple myeloma, as we plan to build upon this indication with continued development across the expansive MagnetisMM program,” said Angela Hwang, chief commercial officer and president of Global Biopharmaceuticals Business at Pfizer.

The approved indication also contains data from cohort B of the study. Of 63 patients, 33% had an objective response after a median follow-up of 10.2 months. Additionally, approximately 84% of patients had a response for at least 9 months.

Regarding safety, the most common adverse effects (AEs) were cytokine release syndrome, fatigue, injection site reaction, diarrhea, upper respiratory tract infection, and musculoskeletal pain. Grade 3/4 AEs included decreased lymphocytes, decreased neutrophils, decreased hemoglobin, decreased white blood cells, and decreased platelets.

The FDA granted priority review to elranatamab as a treatment for those with relapsed/refractory multiple myeloma in February 2023.²

References

1. Pfizer’s Elrexfio receives U.S. FDA accelerated approval for relapsed or refractory multiple myeloma. News release. Pfizer. August 14, 2023. Accessed August 14, 2023. https://bit.ly/3DTCRIY
2. Pfizer’s elranatamab receives FDA and EMA filing acceptance. News release. Pfizer. February 22, 2023. Accessed August 14, 2023. http://bit.ly/3KtAwsI