Work

Linvoseltamab in Patients With Relapsed/Refractory Multiple Myeloma in the LINKER-MM1 Study: Longer Follow-Up and Subgroup Analyses

Year: 2025

Type: article

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 (e.g., 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. MicroAbstract: With 21.3 months' median follow-up, linvoseltamab demonstrated durable efficacy in patients with relapsed/refractory multiple myeloma (RRMM), with an objective response rate of 71% (≥ complete response 52%) and median progression-free survival not reached. Efficacy was observed across key patient subgroups, including high-risk disease. The safety profile was generally manageable. These findings support linvoseltamab as an effective therapeutic option in RRMM.

Source: Clinical Lymphoma Myeloma & Leukemia

DOI: 10.1016/j.clml.2025.11.004