Regeneron Receives Positive Opinion from EMA for Relapsed and Refractory Multiple Myeloma

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Regeneron Pharmaceuticals announced on Feb. 28, 2025 that the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has given the company’s Lynozyfic (linvoseltamab) conditional marketing authorization for treatment of relapsed and refractory (R/R) multiple myeloma (MM). The recommendation is for patients who have received at least three prior therapies, such as a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, but after which the disease has progressed. CHMP’s recommendation is now with the European Commission for a final decision.

An investigational BCMAxCD3 bispecific antibody, linvoseltamab is “designed to bridge B-cell maturation antigen (BCMA) on MM cells with CD3-expressing T cellsto facilitate T-cell activation and cancer-cell killing,” according to the company (1).CHMP’s decision is based on data from the LINKER-MM1 trial that evaluated adults with R/R MM treated with linvoseltamab. There are 282 patients enrolled in the trial, which is an ongoing open-label, multicenter Phase I/II dose-escalation and dose-expansion trial.

“The Phase I dose-escalation portion of the trial—which is now complete—primarily assessed safety, tolerability and dose-limiting toxicities across nine dose levels of linvoseltamab and explored different administration regimens. The ongoing Phase II dose expansion portion is assessing the safety and anti-tumor activity of linvoseltamab, with the primary endpoint of objective response rate. Key secondary endpoints include duration of response, progression-free survival, rate of minimum residual disease negative status and overall survival,” the company stated in the press release.

Patients will be required to receive at least three prior treatments or have triple-class refractory MM to be eligible for Phase II of the study. “Linvoseltamab is administered with an initial step-up dosing regimen followed by the full 200 mg dose administered weekly. At week 16, all patients transition to every two-week dosing. A response-adapted regimen further enables patients to shift to every four-week dosing if they achieve a very good partial response or better and have completed at least 24 weeks of therapy. The regimen requires a total of two 24-hour hospitalizations for safety monitoring,” the company stated in the release.

A broad clinical development program is evaluating linvoseltamab as a monotherapy and in combination with regimens in different lines of MM therapy, including plasma cell precursor disorders. Linvoseltamab is being reviewed in a Phase Ib trial with other cancer treatments in R/R MM and a Phase III confirmatory trial as a monotherapy for R/R MM.

According to EMA, side effects associated with linvoseltamab include musculoskeletal pain, cytokine release syndrome, neutropenia, cough, diarrhea, anemia, fatigue, pneumonia, and upper respiratory tract infection (2).

In the United States, FDA is reviewing Regeneron’s biologics license application for linvoseltamab. FDA’s target action date for the decision on the drug’s approval is July 10, 2025.

Multiple myeloma is the second most common blood cancer, according to Regeneron, with more than 35,000 new cases diagnosed in Europe each year and 187,000 new cases worldwide every year. In MM, cancerous plasma cells crowd out healthy blood cells in the bone marrow. Then it invades other tissues and may cause life-threatening organ injury. MM is not curable at the moment, but current treatments may slow down progression; however, most patients will see their cancer progress and need further treatment, according to the company.

References

1. Regeneron. Linvoseltamab Recommended for EU Approval by the CHMP to Treat Relapsed/Refractory Multiple Myeloma. Press Release. Feb. 28, 2025.
2. EMA. Lynozyfic. Product Overview. ema.europa.eu https://www.ema.europa.eu/en/medicines/human/EPAR/lynozyfic (accessed March 4, 2025.)