Updated Linvoseltamab Data Highlights Deepening Responses in Heavily Pre-Treated Multiple Myeloma Patients

Regeneron Pharmaceuticals recently shared promising 14-month median follow-up data from its Phase 1/2 LINKER-MM1 trial of linvoseltamab, a bispecific antibody for relapsed/refractory multiple myeloma (R/R MM). These findings were presented at the European Hematology Association Congress 2024 and published in the Journal of Clinical Oncology. The results showed enhanced responses compared to the 11-month follow-up data previously presented.

Linvoseltamab targets B-cell maturation antigen (BCMA) on multiple myeloma cells and CD3-expressing T cells, promoting T-cell activation and cancer-cell destruction. The new data revealed that 50% of patients achieved a complete response or better, with an overall response rate of 71%. Suzanne Lentzsch, MD, PhD, from Columbia University, highlighted the drug's efficacy in patients whose cancer was unresponsive to standard treatments.

The trial involved 117 patients treated with a 200 mg dose of linvoseltamab. Key outcomes included a 71% objective response rate, with 63% achieving a very good partial response or better. The median duration of response was 29 months, with the median not reached for those achieving a complete response. Additionally, the study showed a high probability of maintaining response at 12 months: 81% for partial responders and 95% for complete responders. Median progression-free survival was not reached, with a 70% probability of being progression-free at 12 months, increasing to 96% for complete responders. Overall survival was 31 months for all patients.

Safety data remained consistent, with cytokine release syndrome being the most common adverse event, occurring in 46% of patients. Other significant adverse events included infections and neutropenia. There were six treatment-related deaths, primarily due to infections.

A retrospective study comparing linvoseltamab to real-world standard-of-care (SOC) treatments was also presented. The study included 105 linvoseltamab-treated patients and 101 SOC-treated patients, showing superior outcomes for linvoseltamab: a 70% objective response rate versus 32% for SOC, and a median progression-free survival of 20 months compared to 3 months for SOC. Overall survival for linvoseltamab was not reached, whereas it was 12 months for SOC.

Linvoseltamab has received Fast Track Designation in the U.S. and is under Priority Review by the FDA, with a target decision date of August 22, 2024. The European Medicines Association is also reviewing the drug. Ongoing trials, including the Phase 3 LINKER-MM3, continue to evaluate linvoseltamab's efficacy and safety.

Multiple myeloma, the second most common blood cancer, affects over 176,000 people worldwide annually. Despite treatment advances, the disease remains incurable, and many patients experience cancer progression.

The LINKER-MM1 trial is an ongoing, open-label, multicenter study. Phase 1 focused on safety and tolerability, while Phase 2 is assessing safety and anti-tumor activity, with a primary endpoint of objective response rate. Secondary endpoints include duration of response, progression-free survival, and overall survival. Patients receive an initial dosing regimen followed by a maintenance dose, with potential adjustment based on disease response.

Regeneron is also conducting additional trials in earlier stages of multiple myeloma and in combination therapies. These efforts reflect Regeneron's commitment to developing innovative treatments for blood cancers and other serious diseases.

Regeneron's extensive research in hematology leverages its proprietary technologies to develop bispecific antibodies and other therapeutic modalities, aiming to provide effective and customized cancer treatments.