TIDMGSK
RNS Number : 0111T
GlaxoSmithKline PLC
14 July 2020
Issued: 14 July 2020, London UK - LSE Announcement
GSK announces FDA advisory committee votes in favour of positive
benefit/risk profile for belantamab mafodotin for patients with
relapsed/refractory multiple myeloma
-- Recommendation based on review of DREAMM clinical trial
programme, including the pivotal DREAMM-2 study
-- If approved, belantamab mafodotin will be a first-in-class
anti-BCMA therapy for the treatment of relapsed/refractory multiple
myeloma
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/ .
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.
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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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