NEW YORK - Regeneron (NASDAQ:REGN) Pharmaceuticals has announced encouraging results from its phase 1/2 LINKER-M1 trial for the treatment of relapsed or refractory multiple myeloma (R/R MM) with linvoseltamab, an experimental therapy.
The trial reported a robust objective response rate (ORR) of 71% and a complete response rate of 46% at a 200 mg dose over an average follow-up period of 11 months. These findings, released Thursday, signal significant progress in the development of linvoseltamab, which has demonstrated superior early efficacy data compared to other treatments like Tecvayli and Elrexfio.
The promising outcomes have set the stage for Regeneron to plan a regulatory filing. The company aims to target patients who have undergone a median of five prior therapies, including proteasome inhibitors and anti-CD38 monoclonal antibodies. Despite the high overall adverse event rate observed in the trial, serious cytokine release syndrome (CRS) was minimal, with only one grade 3 case reported among participants.
Regeneron's oncology pipeline is not limited to linvoseltamab. It includes odronextamab in phase 3 trials for non-Hodgkin lymphoma (NHL), ubamatamab in phase 2 trials against ovarian cancer, and Libtayo approved for various carcinomas. Additionally, fianlimab combined with Libtayo has been granted Fast Track status for metastatic melanoma treatment and is awaiting an FDA decision expected by March 31, 2024.
The company also revealed that linvoseltamab’s dosing regimen could potentially offer an advantage over competitors by proposing extended intervals between doses for patients who respond well to the treatment. This would be a significant improvement over Tecvayli's weekly administration schedule.
Further clinical investigations are underway with the ongoing phase 3 LINKER-MM3 trial assessing linvoseltamab combined with other treatments in less heavily pretreated patients and the phase 1/2 LINKER-MM4 trial targeting treatment-naïve individuals.
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