LONDON, July 14, 2020 /PRNewswire/ -- GlaxoSmithKline plc
(LSE/NYSE: GSK) today announced the US Food and Drug Administration
(FDA) Oncologic Drugs Advisory Committee (ODAC) voted 12-0 in
favour of the demonstrated benefit of monotherapy treatment with
belantamab mafodotin outweighing the risks for patients with
relapsed or refractory multiple myeloma who have received at least
four prior therapies including an immunomodulatory agent, a
proteasome inhibitor and an anti-CD38 antibody. Two committee
members could not participate in the final vote.
Dr Axel Hoos, Senior Vice
President and Head of Oncology R&D, GSK said: "We are pleased
the committee recognised the potential for belantamab mafodotin to
help patients who have relapsed or refractory multiple myeloma, an
incurable disease with limited treatment options. We look forward
to working with the FDA as they complete their review of our
Biologics License Application."
The recommendation was based on data from the DREAMM (DRiving
Excellence in Approaches to Multiple Myeloma) clinical trial
programme, including the pivotal DREAMM-2 study which enrolled
heavily pre-treated patients who had actively progressing multiple
myeloma that had worsened despite current standard of
care.i The six-month primary results from the study were
published in The Lancet Oncology in December 2019 and serve as the basis for the
Biologics License Application (BLA).
The FDA will consider the recommendation of the committee but is
not obligated to follow it. The FDA granted breakthrough therapy
designation to belantamab mafodotin in 2017 and priority review
designation for the BLA earlier this year. A Marketing
Authorisation Application for belantamab mafodotin also is under
accelerated assessment by the European Medicines Agency.
Belantamab mafodotin is not currently approved for use anywhere
in the world.
About belantamab mafodotin (GSK2857916)
Belantamab
mafodotin is an investigational 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 POTELLIGENT
Technology licensed from BioWa.
About DREAMM-2
DREAMM-2 is an open label study of
belantamab mafodotin. Patients in the trial had actively
progressing multiple myeloma that had worsened despite current
standard of care and were randomised to two arms to receive either
2.5 mg/kg or 3.4 mg/kg belantamab mafodotin every three weeks.
Overall, patients in DREAMM-2 had more advanced disease, poorer
prognosis and performance status and also had a greater number of
prior lines of therapy in comparison with patients in DREAMM-1, the
first time in human study of belantamab mafodotin.
About multiple myeloma
Multiple myeloma is the second
most common blood cancer in the US and is generally considered
treatable, but not curable.ii Research into new
therapies is needed as multiple myeloma commonly becomes refractory
to available treatments.iii
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 (B-cell activating factor)
and APRIL (a proliferation-inducing ligand). 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.iii
GSK in Oncology
GSK is focused on maximising 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.
About GSK
GSK is a science-led global healthcare
company with a special purpose: to help people do more, feel
better, live longer. For further information please visit
www.gsk.com/about-us/.
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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
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factors include, but are not limited to, those described under Item
3.D "Risk Factors" in the company's Annual Report on Form 20-F for
2019 and any impacts of the COVID-19 pandemic.
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i Lonial, S, et al. Belantamab mafodotin for
relapsed or refractory multiple myeloma (DREAMM-2): a two-arm,
randomised, open-label, phase 2 study. Lancet Oncol. 2020;
21(2):207–21.
ii Kazandjian D. Multiple myeloma epidemiology and
survival: A unique malignancy. Semin Oncol. 2016;43(6):676–681.
doi:10.1053/j.seminoncol.2016.11.004.
iii Nooka A, Kastritis E, Dimopoulos M, Lonial S.
Treatment options for relapsed and refractory multiple myeloma.
Blood. 2015;125(20):3085-3099.
doi:10.1182/blood-2014-11-568923.
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