- Regeneron Pharmaceuticals (REGN, Financial) announces promising results from Phase 1b LINKER-MM2 trial for relapsed/refractory multiple myeloma.
- Linvoseltamab with carfilzomib showed a 90% objective response rate, and with bortezomib, an 85% response rate.
- FDA review for linvoseltamab is expected by July 10, 2025.
Regeneron Pharmaceuticals (REGN) has unveiled initial data from its Phase 1b LINKER-MM2 trial, which explores the efficacy of linvoseltamab in combination with proteasome inhibitors for relapsed/refractory multiple myeloma. The trial tested two combinations: linvoseltamab with carfilzomib and linvoseltamab with bortezomib.
The linvoseltamab and carfilzomib combination achieved a 90% objective response rate with 76% of patients achieving a complete response. Importantly, the probability of maintaining this response at 12 months was 87%, with an 83% probability of remaining progression-free over the same period.
For the combination of linvoseltamab and bortezomib, the objective response rate was 85%, with a complete response rate of 50%. Both regimens demonstrated manageable safety profiles, with common side effects including neutropenia, cytokine release syndrome, and thrombocytopenia.
Linvoseltamab is already approved in the European Union for treating this form of multiple myeloma, and the U.S. FDA is expected to complete its review by July 10, 2025. These promising results suggest potential advancements in treatment options for patients who have already been heavily pre-treated for this disease.
