Regeneron Pharmaceuticals, Inc. announced recently,The European Commission (EC) has granted conditional approval for Lynozyfic (linvoseltamab) to be marketed., for the treatment of adult patients with relapsed/refractory multiple myeloma (MM) who have previously received at least three types of therapy (including proteasome inhibitors, immunomodulatory agents, and anti-CD38 monoclonal antibodies), and have experienced disease progression after their last treatment.Linvoseltamab is a bispecific antibody that promotes T-cell activation and tumor cell killing by connecting B-cell maturation antigen (BCMA) on the surface of MM cells with CD3 on the surface of T cells.

The European Commission's approval was based on the positive results of the pivotal clinical trial LINKER-MM1, which showed that patients with relapsed/refractory MM achieved strong and durable responses.Data showed an objective response rate (ORR) of 71%, with 50% of patients achieving complete response (CR) or better outcomes.As assessed by the independent review committee, the proportion of patients achieving CR or stringent CR with minimal residual disease (MRD) negativity was 41% (95% CI: 29-55). The median duration of response (DOR) was 29 months (95% CI: 19 months - not estimable).

The most common adverse events included musculoskeletal pain (52%), cytokine release syndrome (CRS, 46%), neutropenia (43%), cough (42%), diarrhea (39%), anemia (38%), fatigue (36%), pneumonia (32%), and upper respiratory tract infection (30%). CRS cases were mainly grade 1 (35%) or grade 2 (10%), with one case of grade 3 CRS (0.9%), and no ≥grade 4 CRS was observed.

The press release pointed out,Linvoseltamab is the first approved BCMA/CD3 bispecific antibody therapy that allows for dose adjustment based on patient response.After completing at least 24 weeks of treatment, patients who achieve a very good partial response (VGPR) or better may opt for a dosing regimen of once every 4 weeks.

Linvoseltamab is a bispecific antibody designed to connect BCMA on multiple myeloma cells with CD3 expressed on the surface of T cells, promoting T-cell activation and cancer cell killing. Dr. Karen Rodriguez-Lorenc, Global Program Leader for linvoseltamab at Regeneron, previously told industry media Fierce Biotech that among comparable drugs, linvoseltamab demonstrated a CRS incidence rate in the lower range. Since linvoseltamab is administered intravenously, CRS cases occur earlier in the treatment process, making them easier to monitor and manage. Additionally, the drug’s response rate is in the higher range among similar therapies, positioning linvoseltamab as a potential "best-in-class" bispecific antibody targeting BCMA and CD3. In the U.S., the FDA has accepted the Biologics License Application (BLA) for linvoseltamab for the treatment of adult patients with relapsed/refractory MM, with a review expected to be completed by July 10, 2025.

References:

[1] Lynozyfic™ (linvoseltamab) Approved in the European Union for the Treatment of Relapsed/Refractory Multiple Myeloma. Retrieved April 29, 2025, from https://www.globenewswire.com/news-release/2025/04/28/3069071/0/en/Lynozyfic-linvoseltamab-Approved-in-the-European-Union-for-the-Treatment-of-Relapsed-Refractory-Multiple-Myeloma.html

[2] Regeneron touts possible 'best-in-class' myeloma bispecific, but adverse events climb to 100%. Retrieved April 29, 2025, from https://www.fiercebiotech.com/biotech/regeneron-nears-fda-filing-promising-myeloma-drug-linvoseltamab-safety-remains-factor

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