Скачать или смотреть Linvoseltamab in the Treatment of Relapsed/Refractory Multiple Myeloma

Joshua Richter, MD, Associate Professor of Medicine at the Tisch Cancer Institute, Director of Multiple Myeloma at the Blavatnik Family- Chelsea Medical Center at Mount Sinai, discusses the recent U.S. Food and Drug Administration (FDA) approval of linvoseltamab for the treatment of 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. Most patients with MM require multiple lines of therapy as patients are prone to relapse and/or refractory to therapy.

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 was granted accelerated approval on July 10, 2025 for adult patients with relapsed/refractory MM who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

The approval followed data from the ongoing, open-label, multicenter, phase 1/2 dose-escalation and dose-expansion LINKER-MM1 (NCT03761108) clinical trial evaluating linvoseltamab in over 300 patients with MM.

Patients experienced a 70% objective response rate, with 45% achieving a complete response or better. Median time to first response was 0.95 months, however median duration of response was not reached. The estimated duration of response was 89% at 9 months and 72% at 12 months among responders with a median follow-up of 13 months.

Linvoseltamab comes with a Boxed Warning for cytokine release syndrome and neurologic toxicity. The most common adverse events included musculoskeletal pain, CRS, cough, upper respiratory infection, diarrhea, fatigue, pneumonia, nausea, headache, and dyspnea.

Chapters:
Introduction 00:00
Multiple Myeloma Landscape 1:07
Linvoseltamab Overview 3:03
Take Home Message 4:50