Robert Orlowski, MD, PhD, Professor of Medicine at the University of Texas MD Anderson Cancer Center, discusses results from the LINKER-MM4 clinical trial testing Lynozyfic (linvoseltamab) to treat patients with newly diagnosed multiple myeloma (MM).
MM is a form of cancer that occurs due to abnormal and uncontrolled growth of plasma cells in the bone marrow. When present, the most common symptom is anemia, which can be associated with fatigue and shortness of breath. Other features of the condition may include multiple infections, abnormal bleeding, bone pain, weak and/or easily broken bones, and numbness and/or weakness of the arms and legs. The exact underlying cause of MM is currently unknown.
Linvoseltamab is a fully human BCMAxCD3 bispecific antibody designed to bridge B-cell maturation antigen on MM cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing. It is currently approved by the U.S. Food and Drug Administration (FDA) to treat relapsed/refractory MM after four prior lines of therapy.
Data from the phase 1/2 LINKER-MM4 (NCT05828511) clinical trial evaluating linvoseltamab in newly diagnosed multiple myeloma was recently presented at the 2025 American Society of Hematology (ASH) Annual Meeting. Data includes safety and efficacy in two trial phases: Phase 1 dose escalation (phase 1A) and phase 1 dose expansion (phase 1B). By April 28, 2025, 45 patients had received linvoseltamab with a median follow-up of 11.2 months in phase 1A and 4.8 months in phase 1B.
Among 43 patients with available responses, the overall response rate was 79%. Among patients receiving 200 mg, overall response rate was 86%, and in patients receiving 50 mg, overall response rate was 72%. Median time to partial response or better was 1.2 months and 9 out of 11 complete responses were within 6 months of treatment initiation. 22 out of 24 MRD-evaluable patients were MRD negative at or below the 10-5 threshold. All were progression free at cutoff.
No dose-limiting toxicities (DLTs) were observed in any patients. The most common non-hematologic treatment-emergent adverse event was cytokine release syndrome which was reported in 44% of patients. All events were grade 1. The most common hematologic adverse events were neutropenia and anemia. One immune effector cell-associated neurotoxicity syndrome event was observed and resolved. Infections occurred in 82% of patients.
For more information, click here.
To learn more about MM and other rare cancers, visit https://checkrare.com/diseases/cancers/
