Report of Foreign Issuer (6-k)
August 23 2019 - 8:29AM
Edgar (US Regulatory)
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 August, 2019
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: 23 August 2019, London UK
GSK announces positive headline results from the pivotal DREAMM-2
study for multiple myeloma
Belantamab mafodotin (GSK2857916) on track for regulatory
submission by the end of 2019
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced positive
headline results from the pivotal DREAMM-2 open-label, randomised
study of two doses of belantamab mafodotin
(GSK2857916).
The 196 patients in the trial had relapsed multiple myeloma, were
refractory to an immunomodulatory drug, a proteasome inhibitor, and
to treatment with an anti-CD38 antibody. The two-arm study met its
primary objective and demonstrated a clinically meaningful overall
response rate with belantamab mafodotin in the patient population.
The safety and tolerability profile was consistent with that
observed in DREAMM-1, the first time in human study of belantamab
mafodotin.
Dr Hal Barron, Chief Scientific Officer and President R&D, GSK
said: "I am pleased with the results of the DREAMM-2 study and
excited about what these data could mean for patients with multiple
myeloma who have exhausted other lines of treatment. We are
on track to file belantamab mafodotin later this year and continue
to investigate how it could help even more patients with this
disease."
Data from the DREAMM-2 study will be the basis for regulatory
filings starting later this year.
Multiple myeloma is the second most common blood cancer and is
generally considered treatable, but not curable[i].
Research into new therapies is needed as multiple myeloma commonly
becomes refractory to available treatments.
Safety and efficacy results from the DREAMM-2 study will be
submitted for presentation at an upcoming scientific meeting.
Additional ongoing studies are testing the effect of belantamab
mafodotin as third-line monotherapy in relapsed/refractory multiple
myeloma and as a combination treatment in the first and second line
setting as part of the broader DREAMM clinical development
programme.
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 the DREAMM clinical trial programme for belantamab mafodotin
(GSK2857916)
Belantamab mafodotin is an immuno-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 technology licensed
from BioWa.
Belantamab mafodotin is currently being investigated in patients
with multiple myeloma.
|
Trial Name
|
GSK ID/NCT ID
|
Status
|
Design
|
|
DREAMM-1
|
117159/
NCT02064387
|
Active,
not recruiting
|
A Phase
I Open-label Study to Investigate the Safety, Pharmacokinetics,
Pharmacodynamics, Immunogenicity and Clinical Activity of
Belantamab Mafodotin (GSK285791) in Subjects with
Relapsed/Refractory Multiple Myeloma and Other Advanced Hematologic
Malignancies Expressing BCMA
|
|
DREAMM-2
|
205678/NCT03525678
|
Active,
not recruiting
|
A 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
|
|
DREAMM-3
|
207495
|
Planned
|
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
|
|
DREAMM-4
|
205207/NCT03848845
|
Recruiting
|
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
|
|
DREAMM-5
|
208887
|
Planned
|
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
|
|
DREAMM-6
|
207497/NCT03544281
|
Recruiting
|
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
|
|
DREAMM-7
|
207503
|
Planned
|
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
|
|
DREAMM-8
|
207499
|
Planned
|
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
|
|
DREAMM-9
|
209664
|
Planned
|
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
|
|
DREAMM-10
|
207500
|
Planned
|
A Phase
III Study of Belantamab Mafodotin (GSK2857916) Administered in
Combination with a Novel Agent versus SoC
|
|
ISS / GSK
Co-Sponsored Study
|
209418
|
Recruiting
|
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
|
Belantamab mafodotin is not currently approved for use anywhere in
the world.
GSK in Oncology
GSK is focused on maximizing 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.
[i] https://www.cancer.net/cancer-types/multiple-myeloma/statistics
Last accessed August 2019.
[ii] Robert O. Carpenter, Moses O. Evbuomwan, [...], and James N.
Kochenderfer. B-cell Maturation Antigen is a Promising Target for
Adoptive T-cell Therapy of Multiple Myeloma. Clin Can
Res
|
GSK enquiries:
|
|
|
|
|
UK
Media enquiries:
|
Simon
Moore
|
+44 (0)
208 047 0907
|
(London)
|
|
|
|
|
|
|
US
Media enquiries:
|
Kristen
Neese
|
+1
(804) 217-8147
|
(Philadelphia)
|
|
|
|
|
|
|
Analyst/Investor
enquiries:
|
Sarah
Elton-Farr
|
+44 (0)
20 8047 5194
|
(London)
|
|
|
Danielle
Smith
|
+44 (0)
20 8047 2406
|
(London)
|
|
|
James
Dodwell
|
+44 (0)
20 8047 2406
|
(London)
|
|
|
Jeff
McLaughlin
|
+1 215
751 7002
|
(Philadelphia)
|
|
Cautionary statements 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
Principal risks and uncertainties in the company's Annual Report on
Form 20-F for 2018.
Registered in England & Wales:
No. 3888792
|
|
|
|
|
Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS
|
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.
|
|
GlaxoSmithKline plc
|
|
|
(Registrant)
|
|
|
|
|
Date: August
23, 2019
|
|
|
|
|
|
|
By:/s/ VICTORIA
WHYTE
--------------------------
|
|
|
|
|
|
Victoria Whyte
|
|
|
Authorised
Signatory for and on
|
|
|
behalf
of GlaxoSmithKline plc
|
GSK (NYSE:GSK)
Historical Stock Chart
From Oct 2024 to Nov 2024
GSK (NYSE:GSK)
Historical Stock Chart
From Nov 2023 to Nov 2024
