Promising Results of Linvoseltamab in Relapsed/Refractory Myeloma: LINKER-MM1 Study

Dr. Suzanne Lentzsch, MD, PhD from Columbia University Irving Medical Center gave an oral presentation at the European Hematology Association in Madrid on updates for relapsed and refractory myeloma patients with a one-drug-only therapy, linvoseltamab. 

During her presentation, Dr. Lentzsch presented the 14-month follow-up of the actively recruiting study LINKER-MM1. 

It is important to explore the possibility of using one single medication in patients who are commonly heavily treated with five lines of treatment or more. Monotherapy with Linvoseltamab could change the treatment course for relapsed and refractory myeloma patients, facilitating treatment with just one medication that effectively controls the myeloma. 

What Is Linvoseltamab? 

Linvoseltamab is a bispecific antibody that binds to BCMA and CD3, and works by alerting T-cells of cancer cells and promoting their destruction. 

Linvoseltamab is unique because it is that it’s a fully humanized antibody meaning that is an antibody created specifically to bind to a specific region, and it’s less likely to awake a negative immune response when administered, it is given intravenously and needs to be administered in the clinic. 

Who Can Participate in the LINKER-MM1 Study?

Patients with relapsed and refractory myeloma who have been treated with or are resistant to three main drug classes (proteasome inhibitors, immunomodulatory drugs, and anti-CD38 monoclonal antibodies).

How Is Linvoseltamab Used in the LINKER-MM1 Study? 

The patients received monotherapy, meaning that it was the only treatment for their myeloma. Linvoseltamab is given weekly for 14 weeks, then every two weeks. If a very good partial response or better is achieved, the treatment shifts to once every 4 weeks.

What Are the Results So Far? 

The results are based on the 117 patients who participated so far. These results are from a 14-month follow-up. 

• The overall response rate (ORR) was 71%, and 78% of responders maintained their response at 12 months
• 62% achieved very good partial response (VGPR) and 46% achieved complete response (CR)
• For patients achieving complete response or better, 92% maintained the response at 12 months

The progression-free survival (PFS) probability at 12 months is 69%. Overall survival (OS) probability at 12 months is 75%. 

The most encouraging response was for patients in complete remission or better, with a 95% progression-free survival probability at 12 months and a probability of 100% overall survival. 

Is Linvoseltamab Effective for High-Risk Myeloma Patients? 

Yes, so far the study reported high response rates in patients with plasmacytomas and high cytogenetic risk. 

Older patients aged 75+ had an overall response of 71%, with 52% achieving complete remission or better. And importantly for Black patients, the overall response was 85%, with 35% achieving complete remission or better. 

What Are the Side Effects of Monotherapy with Linvoseltamab? 

• Common side effects included cytokine release syndrome (46%), low neutrophil count (a type of white blood cell that helps fight infections) (41%), and anemia (39%).
• Infections were reported in 73% of patients but decreased in frequency and severity after six months.

Linvoseltamab is highly effective and durable in treating relapsed or refractory myeloma, even in high-risk groups. These promising results highlight its potential as a significant treatment option, pending further long-term data.

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Sources: 

• LINKER-MM1 study: Linvoseltamab (REGN5458) in patients with relapsed/refractory multiple myeloma.
• LINVOSELTAMAB IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA IN THE LINKER-MM1 STUDY: DEPTH AND DURABILITY OF RESPONSE AT 14-MONTH MEDIAN FOLLOW-UP
• Phase 1/​2 Study of REGN5458 in Adult Patients With Relapsed or Refractory Multiple Myeloma (LINKER-MM1)