4 days ago · The BLA is supported by data from the pivotal LINKER-MM1 trial investigating linvoseltamab in R/R MM, and linvoseltamab is also under review by the European Medicines Agency (EMA) for the same patient population. Linvoseltamab is investigational and has not been approved by any regulatory authority. About Multiple Myeloma

Jun 16, 2024 · We present a phase I/II first-in-human trial evaluating the safety and efficacy of 50 mg and 200 mg doses of linvoseltamab, a B-cell maturation antigen × CD3 bispecific antibody in relapsed/refractory multiple myeloma (RRMM).

Aug 20, 2024 · Linvoseltamab is a BCMAxCD3 bispecific antibody in development for the treatment of relapsed/refractory multiple myeloma. Multiple myeloma is a blood cancer characterized by the proliferation of cancerous plasma cells (multiple myeloma cells) that crowd out healthy blood cells in the bone marrow, infiltrate other tissues and cause potentially ...

1 day ago · Linvoseltamab will be administered with an initial step-up dosing regimen, followed by a 200-milligram weekly dose. All patients will transition to biweekly dosing at week 16. A response-adapted regimen allows patients who achieve a very good partial response or better and have completed at least 24 weeks of therapy to shift to dosing every ...

4 days ago · Linvoseltamab is a bispecific antibody designed to bridge B-cell maturation antigen on multiple myeloma cells with CD3-expressing T cells. The BLA is supported by data from the phase 1/2 trial LINKER-MM1 trial. Results from this trial were released in December 2023. At a median duration of follow-up of 11 months where 117 patients received ...

Feb 21, 2024 · Linvoseltamab is an investigational bispecific antibody designed to bridge B-cell maturation antigen on multiple myeloma cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing.

3 days ago · Linvoseltamab is being evaluated in an extensive clinical development program assessing its potential both as a monotherapy and in combination regimens across various treatment settings for multiple myeloma, including earlier lines of therapy and plasma cell precursor disorders. 1

Jun 16, 2024 · Purpose: We present a phase I/II first-in-human trial evaluating the safety and efficacy of 50 mg and 200 mg doses of linvoseltamab, a B-cell maturation antigen × CD3 bispecific antibody in relapsed/refractory multiple myeloma (RRMM).

Nov 5, 2024 · Linvoseltamab 200 mg induced prolonged response and survival in patients with RRMM, including those with difficult to treat refractory disease and high tumor burden (high sBCMA concentration or BMPC percentage), while maintaining a …

Nov 2, 2023 · Linvoseltamab, a B-cell maturation antigen (BCMA)×CD3 bispecific antibody, demonstrated promising efficacy and generally manageable safety as therapy for relapsed/refractory multiple myeloma (RRMM; Lee et al. ASCO 2023). Here we report additional analysis of efficacy, including response pattern over time, and safety. Methods