Novartis has begun a new Phase 3 trial of its BCMAxCD3 T-cell engager antibody, called linvoseltamab, for patients with relapsed or refractory multiple myeloma. The trial is called LINKER-MM3 and aims to compare linvoseltamab with two standard treatment options: elotuzumab plus pomalidomide and dexamethasone (EPd), or carfilzomib plus dexamethasone (Kd).
Linvoseltamab was previously known as REGN5458 and was licensed to Novartis from Regeneron. Regeneron shared earlier results from the Phase 1/2 LINKER-MM1 trial at the 2023 American Society of Clinical Oncology meeting. This earlier study included patients who had already gone through at least three prior lines of therapy. It showed an overall response rate of 71% for linvoseltamab among patients who received the higher 200 mg dose. The complete response or better rate was 46%.
The phase 3 LINKER-MM3 study will track progression-free survival as its primary goal. Dr. Jeff Legos, EVP and Global Head of Oncology Development at Novartis, said, “We have made deep investments in next-generation biologics over the past several years. We are excited by the potential of linvoseltamab and our broader T-cell engager portfolio to offer new options for people living with multiple myeloma.”
This trial adds to a growing list of T-cell engager therapies being investigated for blood cancers. Multiple companies are racing to develop treatments in this rapidly evolving field, hoping to improve survival rates and quality of life for patients with difficult-to-treat forms of cancer.
