Salomon Manier, MD, PhD, Associate Professor of Hematology at Lille University Hospital in France, discusses results from a phase 1b clinical trial evaluating linvoseltamab combination therapy in patients with relapsed/refractory multiple myeloma (MM).
MM is a bone marrow-based plasma cell neoplasm characterized by a serum monoclonal protein and skeletal destruction. Common symptoms include osteolytic lesions, pathological fractures, bone pain, hypercalcemia, and anemia. The exact underlying cause of multiple myeloma is currently unknown.
The LINKER-MM2 clinical trial is a phase 1b, open-label study evaluating linvoseltamab in combination with proteasome inhibitors, carfilzomib or bortezomib, in patients with relapsed/refractory MM. The study included patients who had progressed after at least two lines of therapy and were either double-class refractory or triple-class exposed.
Linvoseltamab is an investigational bispecific antibody designed to bridge B-cell maturation antigen on MM cells with Cd3-expressing T cells to facilitate T-cell activation cancer-cell killing. Initial results from two cohorts of the phase 1b LINKER-MM2 trial were presented at the American Society of Clinical Oncology 2025 Annual Meeting.
In the linvoseltamab plus carfilzomib cohort, results across dose levels demonstrated a 90% objective response rate (ORR), with 76% achieving a complete response (CR). At 12 months, the estimated probability of maintaining a response was 87% and being progression-free was 83%.
Of the 23 patients evaluated for safety data, the most common treatment emergent adverse events (AEs) were neutropenia, cytokine release syndrome, diarrhea, and thrombocytopenia. Additionally, infections occurred in 91% of patients and serious AEs occurred in 83% of patients
In the linvoseltamab plus bortezomib cohort, results across dose levels demonstrated an 80% ORR, with 50% achieving a CR. The most common AEs in this group were neutropenia and thrombocytopenia. Infections occurred in 75% of patients and serious AEs occurred in 83% of patients.
Currently, a registrational, randomized, phase 3 trial investigating linvoseltamab plus carfilzomib against standard of care is in the planning period.
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