Amgen/BeiGene's CD3/BCMA Bispecific Antibody AMG 701 Granted Clinical Trial Approval in China for Relapsed/Refractory Multiple Myeloma

On August 17, the CD3/BCMA bispecific antibody AMG 701, developed by Amgen and BeOne Medicines, received clinical trial approval in China for the treatment of relapsed/refractory multiple myeloma.

BCMA (B-cell maturation antigen) is a membrane protein belonging to the tumor necrosis factor (TNF) receptor superfamily. It is primarily expressed on the surface of late-stage B cells, short-lived proliferating plasmablasts, and long-lived plasma cells, and is present to some extent on memory B cells. However, it is not expressed in naive B cells, CD34-positive hematopoietic stem cells, or other normal tissue cells. BCMA plays a critical role in the survival of long-lived plasma cells but is dispensable for maintaining normal B-cell homeostasis.

Multiple Myeloma (MM) is a malignant plasma cell disorder and ranks as the second most common hematologic malignancy. In MM cases, BCMA expression on malignant plasma cells is significantly higher than that on normal plasma cells, with high BCMA expression observed in up to 60%-70% of multiple myeloma (MM) cases.

Currently, BCMA has become a highly prominent immunotherapeutic target in multiple myeloma (MM) and other hematologic malignancies. Various immunotherapies targeting BCMA are under development, including chimeric antigen receptor T-cell (CAR-T) therapy, bispecific antibodies (BsAbs), and antibody-drug conjugates (ADCs).