Commentary|Videos|September 25, 2025
Promising Responses with Linvoseltamab in Smoldering Myeloma
Author(s)Paula Rodriguez Otero, MD, PhD
Fact checked by: Sabrina Serani
Paula Rodriguez Otero, MD, PhD, discusses promising results of linvoseltamab in high-risk smoldering multiple myeloma, highlighting its potential to prevent disease progression.
In an interview with Targeted Oncology, Paula Rodriguez Otero, MD, PhD, consultant and deputy professor at the University of Navarra, discusses the efficacy of linvoseltamab (Lynozyfic) in high-risk smoldering multiple myeloma (HR-SMM), according to findings from the phase 2 LINKER-SMM1 study.
Linvoseltamab, a BCMA/CD3 bispecific antibody, demonstrated strong early activity in this patient group. Among the 19 patients available for response, the reported efficacy data were highly positive:
- Overall Response Rate (ORR): The ORR was 100%.
- Deepening Responses: Responses occurred very rapidly, with the median time to first response occurring in the first cycle.
- VGPR or Better: 73.7% of the 19 evaluable patients achieved a very good partial response (VGPR) or better.
- Complete Response (CR) Rate in Safety Run-in Cohort: In the first 6 patients enrolled in the safety run-in phase (the cohort with the longest follow-up), 83% of the patients achieved a complete response or better (n = 5/6)
- Minimal Residual Disease (MRD) Negativity: All 12 patients who had available samples were reported to be MRD-negative 10–6 sensitivity. Responses were observed to be deepening over time.
Investigators are confident that with longer follow-up, the depth of response will likely increase in this study.
The primary end points for the expansion phase of the LINKER-SMM1 study relate to deep, sustained responses, focusing on efficacy over a fixed duration of 2 years. The primary end points of the expansion phase (Part 2) are the complete response rate and MRD negativity at 10–5 at 1 year and 2 years.
Secondary efficacy end points include ORR, duration of response, sustained MRD negativity, progression-free survival (PFS), time to a myeloma-defining event, time to initiation of first-line treatment for multiple myeloma, and overall survival.
The overall objective of using such an active drug platform is to determine how effective it will be in the long term in preventing progression to active myeloma. Early data suggest that intervention in high-risk smoldering myeloma, when the immune system is more intact, might significantly delay or even prevent progression to active disease.
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