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): ____
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ____
Issued: 24 July 2020, London UK
GSK receives positive CHMP opinion recommending approval of
belantamab mafodotin for the treatment of relapsed and refractory
multiple myeloma
GlaxoSmithKline
plc (LSE/NYSE: GSK) today announced the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency
(EMA) adopted a positive opinion recommending the approval of
belantamab mafodotin as monotherapy for the treatment of multiple
myeloma in adult patients, who have received at least four prior
therapies and whose disease is refractory to at least one
proteasome inhibitor, one immunomodulatory agent, and an anti-CD38
monoclonal antibody, and who have demonstrated disease progression
on the last therapy.
Dr Axel Hoos, Senior Vice President and Head of Oncology R&D,
GSK said: "Today's positive opinion from the CHMP is an important
step in helping patients suffering from relapsed or refractory
multiple myeloma who currently have limited options and poor
outcomes. If approved, belantamab mafodotin will provide patients
and physicians across much of Europe with a first-in-class
anti-BCMA treatment option that works differently from other
available therapies for this incurable disease."
Belantamab mafodotin was granted PRIME designation in 2017 and the
Conditional Marketing Authorisation Application (CMAA) was reviewed
under EMA's accelerated assessment procedure, which is given if the
CHMP determines the treatment is of major interest from a public
health perspective and represents a therapeutic innovation. The
CHMP positive opinion is one of the final steps before marketing
authorisation is granted by the European Commission, which has the
authority to approve medicines for use throughout the European
Union. If approved, belantamab mafodotin will be marketed as
BLENREP and will be the second major regulatory milestone for GSK's
oncology portfolio this year.
The CMAA is based on data from the pivotal DREAMM-2 (DRiving
Excellence in Approaches to Multiple Myeloma) study including
13-month follow-up data. These data demonstrated that
treatment with single-agent belantamab mafodotin, administered as a
2.5 mg/kg dose every three weeks (Q3W), resulted in an overall
response rate of 32%. Median duration of response was 11 months and
median overall survival was 13.7 months.
The safety and tolerability profile were consistent with previously
reported data on belantamab mafodotin. The most commonly reported
grade 3 or higher adverse events (occurring in more than 10% of
patients) in patients receiving the 2.5 mg/kg dose were
keratopathy/microcyst-like epithelial changes (MECs) (46%),
thrombocytopenia (22%), anaemia (21%), lymphocyte count decreased
(13%) and neutropenia (11%).
Belantamab mafodotin is also under review by the US Food and Drug
Administration which granted a priority review for the company's
Biologics License Application (BLA).
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 Q3W. 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 third most common blood cancer worldwide
and is generally considered treatable, but not
curable.[i] Research
into new therapies is needed as multiple myeloma commonly becomes
refractory to available treatments.[ii]
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 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.
Belantamab mafodotin is not currently approved for use anywhere in
the world.
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Trial
Name
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GSK
ID/NCT ID
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Status
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Design
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DREAMM-1
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117159/
NCT02064387
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Completed
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A Phase
I Open-label Study to Investigate the Safety, Pharmacokinetics,
Pharmacodynamics, Immunogenicity and Clinical Activity of
Belantamab Mafodotin (GSK2857916) in Subjects with
Relapsed/Refractory Multiple Myeloma and Other Advanced Hematologic
Malignancies Expressing BCMA
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DREAMM-2
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205678/
NCT03525678
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Active,
not recruiting
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A Phase
II Study to Investigate the Efficacy and Safety of Two Doses of
Belantamab Mafodotin (GSK2857916) in Subjects with
Relapsed/Refractory Multiple Myeloma Who are Refractory to a
Proteasome Inhibitor and an Immunomodulatory Agent and Have Failed
Prior Treatment with an Anti-CD38 Antibody
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DREAMM-3
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207495/
NCT04162210
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Recruiting
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A Phase
III Open-Label, Randomized Study to Evaluate the Efficacy and
Safety of Belantamab Mafodotin (GSK2857916) Compared to
Pomalidomide plus low-dose Dexamethasone (Pom/Dex) in Participants
with Relapsed/Refractory Multiple Myeloma
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DREAMM-4
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205207/
NCT03848845
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Recruiting
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A Phase
I/II Single Arm Open-Label Study to Explore Safety and Clinical
Activity of Belantamab Mafodotin (GSK2857916) Administered in
Combination with Pembrolizumab in Subjects with Relapsed/Refractory
Multiple Myeloma
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DREAMM-5
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208887/
NCT04126200
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Recruiting
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A Phase
I/II, Randomized, Open-label Platform Study of Belantamab Mafodotin
(GSK2857916) with Innovative Combination Anti-Cancer Treatments in
Participants with Relapsed/Refractory Multiple Myeloma
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DREAMM-6
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207497/
NCT03544281
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Recruiting
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A Phase
I/II Randomized Study to Evaluate Safety, Tolerability and Clinical
Activity of Belantamab Mafodotin (GSK2857916) Administered in
Combination with Lenalidomide plus Dexamethasone (Arm A), or in
Combination with Bortezomib plus Dexamethasone (Arm B) in Subjects
with Relapsed/Refractory Multiple Myeloma
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DREAMM-7
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207503/
NCT04246047
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Recruiting
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A Phase
III Study of Belantamab Mafodotin (GSK2857916) Administered in
Combination with Bortezomib plus Dexamethasone versus Daratumumab,
Bortezomib, and Dexamethasone in Participants with
Relapsed/Refractory Multiple Myeloma
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DREAMM-8
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207499
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Planned
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A Phase
III, Multicentre, Open-Label, Randomized Study to Evaluate the
Efficacy and Safety of Belantamab Mafodotin (GSK2857916) in
Combination with Pomalidomide plus Low-Dose Dexamethasone (BPd)
versus Pomalidomide plus Bortezomib and Low-Dose Dexamethasone
(PVd) in Participants with Relapsed/Refractory Multiple
Myeloma
|
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DREAMM-9
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209664/
NCT04091126
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Recruiting
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A Phase
III Study of Belantamab Mafodotin (GSK2857916) Administered in
Combination with Bortezomib plus Lenalidomide and Low-Dose
Dexamethasone (VRd) vs. VRd in Participants with Newly Diagnosed
Multiple Myeloma who are Ineligible for Transplant
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DREAMM-10
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207500
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Planned
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A Phase
III Study of Belantamab Mafodotin (GSK2857916) Administered in
Combination with a Novel Agent versus SoC
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ISS/GSK
Co-Sponsored Study
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209418/
NCT03715478
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Recruiting
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A Phase
I/II Dose-escalation and Dose-expansion Study of Belantamab
Mafodotin (GSK2857916) Administered in Combination with
Pomalidomide plus Low-dose Dexamethasone in Patients with
Relapsed/Refractory Multiple Myeloma Who Have Received Two or More
Prior Lines of Therapy That Must Have Included Lenalidomide and a
Proteasome Inhibitor
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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 enquiries:
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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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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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Sonya
Ghobrial
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+44 (0)
7392 784784
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(Consumer)
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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] Estimated number of
incident cases worldwide, both sexes, all ages. World Health
Organization.
https://gco.iarc.fr/ Published 2020. Accessed May
2020.
[ii] 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
24, 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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