FDA decision on linvoseltamab in treating RRMM expected in July
Preliminary findings in clinical trial show 70% of patients responded to therapy
The U.S. Food and Drug Administration (FDA) has agreed to review an application from Regeneron Pharmaceuticals seeking the approval of linvoseltamab to treat adults with relapsed or refractory multiple myeloma (RRMM).
The request specifically seeks linvoseltamab’s approval for people with RRMM who have received at least four prior lines of therapy, or who have three prior lines of therapy and failed to respond to the last therapy line. An approval application also is being considered in the European Union for the same patient group.
An FDA decision is expected by July 10, according to a press release from Regeneron.
Linvoseltamab aims to direct T-cells to destroy myeloma cells
Regeneron initially applied asking the FDA to approve linvoseltamab for RRMM more than a year ago. However, the agency rejected the company’s application last year due to issues at a third-party manufacturing facility. According to Regeneron, the third-party manufacturing issues have been resolved.
Myeloma is a type of blood cancer that develops when plasma cells, a type of immune cell, start to grow out of control, forming abnormal growths within bone marrow — the spongy tissue inside of bones where new blood cells are produced. The disease almost always affects more than one spot within the bone marrow, and is called multiple myeloma.
Linvoseltamab is a bispecific antibody therapy, meaning an antibody that’s designed to simultaneously bind to two different targets. Specifically, linvoseltamab works to bind to BCMA — a protein typically expressed by myeloma cells — while also binding to CD3, a protein expressed by T-cells, a type of immune cell that is able to destroy cancer cells. By binding to both these targets at the same time, the therapy essentially aims to direct T-cells to destroy myeloma cells.
Regeneron’s application seeking FDA approval of linvoseltamab is supported by data from the ongoing Phase 1/2 LINKER-MM1 (NCT03761108) study, which is testing the therapy in 282 currently enrolled RRMM patients. The trial is recruiting up to 387 adults who have had at least three previous therapy lines, including a proteasome inhibitor, an immunomodulator, and a CD38 inhibitor, at sites in the U.S., Belgium, Spain, Korea, Japan.
Available data from LINKER-MM1 showed that more than 70% of patients responded to linvoseltamab treatment, with nearly half achieving a complete response or better. A complete response means a person had no signs of cancer following treatment.
Regeneron also is running a Phase 3 study called LINKER-MM3 (NCT05730036) that’s comparing linvoseltamab as a monotherapy to a standard treatment combination of Empliciti (elotuzumab), Pomalyst (pomalidomide), and dexamethasone in RRMM patients who’ve had one to four prior lines of treatment. This study also is enrolling eligible adults at sites worldwide.
Additionally, linvoseltamab is being investigated in two other clinical trials. The Phase 1 LINKER-MM2 trial (NCT05137054) is evaluating its efficacy in combination with other therapies in previously treated multiple myeloma patients, while the Phase 1/2 LINKER-MM4 (NCT05828511) study is assessing linvoseltamab as a first-line treatment for newly diagnosed patients. Both studies are currently enrolling participants in the U.S. and Europe.
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