TIDMGSK
RNS Number : 5484Q
GlaxoSmithKline PLC
19 June 2020
Issued: 19 June 2020, London UK - LSE announcement
GSK announces FDA Advisory Committee meeting to review
belantamab mafodotin for the treatment of patients with
relapsed/refractory multiple myeloma
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced the US Food
and Drug Administration (FDA) will convene a meeting of the
Oncologic Drugs Advisory Committee (ODAC) to review data supporting
the company's Biologics License Application (BLA) for belantamab
mafodotin for the potential treatment of 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. The ODAC will meet virtually
on 14 July 2020.
Dr Axel Hoos, Senior Vice President and Head of Oncology
R&D, GSK said: "We believe belantamab mafodotin and the results
from the DREAMM clinical trial programme have significant potential
for patients with relapsed/refractory multiple myeloma who have
limited treatment options. We look forward to participating in the
upcoming advisory committee meeting and working with the FDA to
complete its review of the BLA."
Belantamab mafodotin received Breakthrough Therapy Designation
in 2017 , and the BLA was granted Priority Review status by the FDA
in January 2020 based on data from the pivotal DREAMM-2 (DRiving
Excellence in Approaches to Multiple Myeloma) study . Six-month
primary results from the study were published in The Lancet
Oncology and follow-up data were presented at the 2020 American
Society of Clinical Oncology annual meeting .
Belantamab mafodotin is a potential first-in-class, humanised,
anti-BCMA (antibody drug conjugate against B-cell maturation
antigen) being investigated in a robust clinical trial programme
for the treatment of multiple myeloma. ([i]) BCMA is a cell-surface
protein that plays an important role in the survival of plasma
cells and is universally expressed in patients with multiple
myeloma. ([ii])
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.[iii]
About multiple myeloma
Multiple myeloma is the second most common blood cancer in the
US and is generally considered treatable, but not curable. ([iv])
Research into new therapies is needed as multiple myeloma commonly
becomes refractory to available treatments. ([v])
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. (ii)
About belantamab mafodotin (GSK2857916)
Belantamab mafodotin is an investigational anti-body 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.
Belantamab mafodotin is not currently approved for use anywhere
in the world.
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 .
GSK enquiries:
UK Media enquiries: Simon Steel +44 (0) 20 8047 (London)
5502
Tim Foley +44 (0) 20 8047 (London)
5502
US Media enquiries: Kristen Neese +1 804 217 8147 (Philadelphia)
Kathleen Quinn +1 202 603 5003 (Washington
DC)
Analyst/Investor Sarah Elton-Farr +44 (0) 20 8047 (London)
enquiries: 5194
Danielle Smith +44 (0) 20 8047 (London)
0932
James Dodwell +44 (0) 20 8047 (London)
2406
Jeff McLaughlin +1 215 751 7002 (Philadelphia)
Frannie DeFranco +1 215 751 4855 (Philadelphia)
Cautionary statement 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
"Risk Factors" in the company's Annual Report on Form 20-F for 2019
and any impacts of the COVID-19 pandemic.
Registered in England & Wales:
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[i] NCI Drug Dictionary - Anti-BCMA Antibody-Drug Conjugate
GSK2857916. National Cancer Institute.
https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-bcma-antibody-drug-conjugate-gsk2857916.
Accessed May 2020.
[ii] Trudel S, Lendvai N, Popat R, et al. Targeting B-cell
maturation antigen with GSK2857916 antibody-drug conjugate in
relapsed or refractory multiple myeloma (BMA117159): a dose
escalation and expansion phase 1 trial. The Lancet Oncology.
2018;19(12):1641-1653. doi:10.1016/s1470-2045(18)30576-x.
[iii] Lonial S, Lee HC, Badros A, et al. Belantamab mafodotin
for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm,
randomised, open-label, phase 2 study. Lancet Oncol. 2020
Feb;21(2):207-221. doi: 10.1016/S1470-2045(19)30788-0. Epub 2019
Dec 16.
[iv] 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.
[v] 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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END
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