Regeneron's Multiple Myeloma Therapy Receives E.U. Approval
The bispecific monoclonal antibody has demonstrated robust and durable responses in patients with relapse/refractory multiple myeloma.
The European Commission has granted conditional marketing authorization to linvoseltamab (Lynozyfic, Regeneron Pharmaceuticals) for the treatment of adults with relapsed/refractory multiple myeloma (RRMM). To be eligible for treatment with linvoseltamab, patients must have undergone at least three prior therapies — including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody (1).
Linvoseltamab is a bispecific monoclonal antibody that targets both CD3 on T cells and B-cell maturation antigen (BCMA) on myeloma cells, facilitating T-cell-mediated cytotoxicity against malignant plasma cells. Data from the Phase I/II LINKER-MM1 trial — that was responsible for the conditional approval — demonstrated an overall response rate of 71% and a complete response rate of 50% amongst heavily pretreated patients.
Dr. Paula Rodriguez-Otero, Department of Hematology at Spain's Cancer Center Clínica Universidad de Navarra highlighted the significance of this approval, stating, in a company press release about the approval (1), that the drug “demonstrated compelling and impressive efficacy with the potential for complete remission in this patient population, including those with high disease burden.”
The approval of linvoseltamab demonstrates the growing importance of bispecific antibodies for the treatment of multiple myeloma. Linvoseltamab and similar therapies use a novel mechanism of action by engaging the patient's own immune system to target cancer cells. Unlike traditional monoclonal antibodies that target a single antigen, bispecific antibodies are engineered to simultaneously bind two different targets and can initiate a potent and localized immune response without the need for external immune activation or prior antigen presentation (2). The high response rates — even in heavily pretreated patients — offer promise to patients that have typically been considered difficult to treat due to the emergence of drug resistance and immune escape.
Bispecifics are also appealing from a logistical standpoint as, unlike chimeric antigen receptor (CAR)-T cell therapies, which require complex and time-consuming manufacturing processes tailored to each patient, many can be delivered off-the-shelf (3). This scalability may allow for broader and more rapid deployment in clinical settings. Additionally, these therapies can often be administered in outpatient settings, reducing the need for hospitalization and making treatment more accessible to patients who may not be near specialized centers, such as those required for CAR-T therapy (4).
Once seen as a niche modality, bispecifics are now gaining ground as viable options for patients with limited alternatives. Several promising bispecific antibodies are advancing through clinical development, aiming to expand treatment options for patients with hematologic malignancies. Several bispecific antibodies are being developed to treat multiple myeloma, reflecting the growing interest in T-cell engaging immunotherapies that target novel antigens beyond traditional approaches. These agents vary by target specificity and are at different stages of regulatory approval and clinical testing (5).
The U.S. FDA is reviewing the Biologics License Application for linvoseltamab in adults with RRMM with a target action date of July 10, 2025. Genentech and Regeneron are advancing cevostamab and linvoseltamab, respectively, through clinical trials.
References
Regeneron. Lynozyfic™ (linvoseltamab) Approved in the European Union for the Treatment of Relapsed/Refractory Multiple Myeloma. Press Release, April 28, 2025.
Lancman, G.; Sastow, D.L.; Cho, H.J.; et al. Bispecific Antibodies in Multiple Myeloma: Present and Future. Blood Cancer Discov. 2021, 2(5), 423–433.
Nath, K.; Mailankody, S.; Usmani, S.; The Role of CAR T-Cell Therapy in the Era of Bispecific Antibodies. Hematol Oncol Clin North Am. 2023, 37(6), 1201–1214.
Hospital Healthcare Europe. Harnessing the Potential of Bispecific antibodies in Blood Cancer Care and Beyond. Clinical News, Feb. 16, 2024.
MyelomaUK. Bispecific Antibodies Horizons Infosheet. Infosheet, September 2024.