GSK announces data on anti-BCMA antibody-drug conjugate in patients with relapsed/refractory multiple myeloma to be presented at European Hematology Association (EHA) Congress
Issued: London, UK
GlaxoSmithKline plc today announced new data on belantamab mafodotin (GSK2857916), an investigational anti-B-cell maturation antigen (BCMA) antibody-drug conjugate, will be presented at the 24th Congress of the European Hematology Association.
The studies being presented at EHA include:
- Abstract #PS1401: Patient Reported Experience from Part 2 of the First Time in Human Study of the BCMA Antibody-Drug Conjugate GSK2857916 for Advanced Relapsed Refractory Multiple Myeloma (DREAMM-1) (Popat R, Opalinska L, Eliason J, et. al)
- Abstract #PS1372: B-cell Maturation Antigen Antibody-Drug Conjugate (ADC), GSK2857916, in Relapsed/Refractory Multiple Myeloma (RRMM): Final Safety, Efficacy and Pharmacokinetic (PK) Analyses From a Pivotal Phase I Study (Popat R, Lendvai S, Trudel PM, et. al)
- Abstract #PF558: The Anti-BCMA Antibody-Drug Conjugate GSK2857916 Drives Immunogenic Cell Death and Immune-Mediated Anti-Tumor Responses, and in Combination with an OX40 Agonist Potentiates in Vivo Activity (Montes De Oca R, Bhattacharya S, Vitali N, et. al)
In 2017, belantamab mafodotin was awarded Breakthrough Therapy designation from the U.S. Food and Drug Administration and PRIME designation from the European Medicines Agency; these designations are intended to facilitate development of investigational medicines that have shown clinical promise for conditions where there is significant unmet need.
About B-cell maturation antigen (BCMA)
The normal function of BCMA is to promote plasma cell survival by transduction of signals from two known ligands, BAFF and APRIL. This pathway has been shown to be important for myeloma cell growth and survival. BCMA expression is limited to B cells at later stages of development. BCMA is expressed at varying levels in myeloma patients and BCMA membrane expression is universally detected in myeloma cell lines[i].
About the DREAMM Clinical Trial Programme for Belantamab Mafodotin (GSK2857916)
Belantamab mafodotin is an antibody-drug conjugate comprising a humanised anti-B cell maturation antigen (BCMA) monoclonal antibody conjugated to the cytotoxic agent auristatin F via non-cleavable linker. The drug linker technology is licensed from Seattle Genetics; monoclonal antibody is produced using technology licensed from BioWa.
Belantamab mafodotin is currently in clinical development in patients with relapsed/refractory multiple myeloma and other advanced haematologic malignancies expressing BCMA.
Belantamab mafodotin is not currently approved for use anywhere in the world.
GSK in Oncology
GSK is focused on maximizing patient survival through transformational medicines. GSK’s pipeline is focused on immuno-oncology, cell therapy, cancer epigenetics and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, antibody drug conjugates and cells, either alone or in combination.
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Cautionary statements regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D Principal risks and uncertainties in the company's Annual Report on Form 20-F for 2018.
[i] Robert O. Carpenter, Moses O. Evbuomwan, [...], and James N. Kochenderfer. B-cell Maturation Antigen is a Promising Target for Adoptive T-cell Therapy of Multiple Myeloma. Clin Can Res