**Regeneron Pharmaceuticals has received a positive opinion from the European Medicines Agency’s human medicines committee for the use of its investigational bispecific antibody linvoseltamab in multiple myeloma (MM).**
The Committee for Medicinal Products for Human Use (CHMP) has recommended that the drug be granted conditional marketing authorisation to treat relapsed and refractory MM in adults who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and have also demonstrated disease progression on their last therapy.
More than 35,000 new cases of MM, an incurable blood cancer that develops in plasma cells in the bone marrow, are diagnosed every year in Europe. While current MM treatments are able to slow its progression, most patients will ultimately experience relapse and require additional therapies.
Linvoseltamab is designed to bridge B-cell maturation antigen on MM cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing.
The CHMP’s decision on the drug was supported by positive results from the phase 1/2 LINKER-MM1 trial, which demonstrated a 71% objective response rate at a media follow-up of 14 months, with 50% of patients achieving a complete response (CR) or better and 63% achieving a very good partial response or better.
The results presented at the European Hematology Association (EHA) Congress also showed a median duration of response (DoR) of 29 months for all linvoseltamab responders, while median DoR was not reached for those who achieved a CR or better.
Median progression-free survival was not reached, and median overall survival of 31 months for all patients.
Suzanne Lentzsch, director of the MM and amyloidosis programme at Columbia University, said at the time of the EHA presentation in June: “Previous results from LINKER-MM1 have demonstrated that linvoseltamab has compelling efficacy characterised by deep and durable responses… Additionally, a study using US-based electronic health record data to indirectly compare linvoseltamab to real-world standard-of-care treatment also supports the overall body of evidence for this investigational medicine in heavily pretreated MM.
“Collectively, these presentations underscore the exciting potential of linvoseltamab as we await decisions from regulatory authorities.”
The European Commission will now consider the CHMP’s recommendation as it makes a final decision on linvoseltamab, expected in the coming months.