Linvoseltamab in Patients With Relapsed/Refractory Multiple Myeloma in the LINKER-MM1 Study: Longer Follow-Up and Subgroup Analyses.
Publication Title
Clin Lymphoma Myeloma Leuk
Document Type
Article
Publication Date
11-12-2025
Keywords
washington; swedish
Abstract
Background: Linvoseltamab, a BCMA × CD3 bispecific antibody, demonstrated durable efficacy and generally manageable safety in patients with relapsed/refractory multiple myeloma (RRMM) in the LINKER-MM1 study (NCT03761108).
Methods: We conducted an updated analysis with a longer median follow-up of 21.3 months for 117 patients from LINKER-MM1 who received linvoseltamab 200 mg, including response data in high-risk subgroups.
Results: As of July 23, 2024 (data cutoff), the objective response rate (ORR) was 71% (complete response or better [≥CR], 52%), with median duration of response of 29.4 months. Median progression-free survival was not reached, and median overall survival was 31.4 months. Minimal residual disease negativity (10-5 threshold) was achieved in 94% of evaluable patients with ≥CR. High response rates were observed across subgroups defined by baseline patient characteristics (age and race) and treatment history (eg, penta-refractory status). Response rates and survival outcomes were favorable in patients with markers of high disease burden (elevated % bone marrow plasma cells or soluble BCMA) or difficult-to-treat RRMM (including extramedullary plasmacytoma, International Staging System stage 3, and high-risk cytogenetic status); ORR was ≥50% in all subgroups assessed. The most common treatment-emergent adverse events were cytokine release syndrome (46%; Grade 3, 1%; most events occurred during step-up dosing) and neutropenia (44%; Grade ≥3, 43%). Infections were reported in 75% of patients (Grade ≥3, 48%), with the rate decreasing after 6 months of treatment.
Conclusions: Long-term treatment with linvoseltamab 200 mg provided deep and durable responses, with no new safety signals, and thus represents an effective therapeutic option in RRMM.
Area of Special Interest
Cancer
Specialty/Research Institute
Oncology
Specialty/Research Institute
Pharmacy
DOI
10.1016/j.clml.2025.11.004
