UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR
15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the
month of July 2020
Commission
File Number 001-15170
GlaxoSmithKline plc
(Translation
of registrant's name into English)
980 Great West Road, Brentford, Middlesex, TW8 9GS
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F . . . .X. . . . Form 40-F . . . . . . . .
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1): ____
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by check mark if the registrant is submitting the Form 6-K in paper
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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:
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UK
Media enquiries:
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Simon
Steel
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+44 (0)
20 8047 5502
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(London)
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Tim
Foley
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+44 (0)
20 8047 5502
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(London)
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US
Media enquiries:
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Kristen
Neese
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+1 804
217 8147
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(Philadelphia)
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Kathleen
Quinn
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+1 202
603 5003
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(Washington
DC)
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Analyst/Investor
enquiries:
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Sarah
Elton-Farr
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+44 (0)
20 8047 5194
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(London)
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Danielle
Smith
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+44 (0)
20 8047 0932
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(London)
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James
Dodwell
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+44 (0)
20 8047 2406
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(London)
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Jeff
McLaughlin
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+1 215
751 7002
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(Philadelphia)
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Frannie
DeFranco
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+1 215
751 4855
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(Philadelphia)
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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:
No.
3888792
Registered Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
[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.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorised.
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GlaxoSmithKline plc
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(Registrant)
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Date: July
15, 2020
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By:/s/ VICTORIA
WHYTE
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GlaxoSmithKline plc
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