FORM 6-K
SECURITIES AND EXCHANGE COMMISSION
Washington D.C. 20549
Report of Foreign Issuer
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
For
period ending 12 December
2017
GlaxoSmithKline plc
(Name
of registrant)
980 Great West Road, Brentford, Middlesex, TW8 9GS
(Address
of principal executive offices)
Indicate
by check mark whether the registrant files or
will
file annual reports under cover Form 20-F or Form 40-F
Form
20-F x Form 40-F
--
Indicate
by check mark whether the registrant by furnishing the
information
contained in this Form is also thereby furnishing the
information
to the Commission pursuant to Rule 12g3-2(b) under the
Securities
Exchange Act of 1934.
Yes
No x
Issued:
Monday 11 December 2017, London UK
GSK presents promising new data for
priority BCMA asset from its emerging Oncology pipeline at
59th ASH meeting
- 60% response rate in heavily
pre-treated relapsed/refractory multiple myeloma patients in phase
I/II DREAMM-1 study
- Investigational BCMA
antibody-drug conjugate GSK2857916 recently awarded PRIME and
Breakthrough Designations
GlaxoSmithKline
plc (LSE/NYSE: GSK) today presented promising new data from the
dose expansion phase of the DREAMM-1 study of GSK2857916, an
investigational anti-B-cell maturation antigen (BCMA) antibody-drug
conjugate. In this study of heavily pre-treated multiple myeloma
patients (n=35), GSK2857916 monotherapy demonstrated a 60% response
rate (95% confidence interval [CI]: 42.1% - 76.1%) and a median
progression free survival of 7.9 months (95% CI: 3.1 - not
estimable). Results were presented during an oral presentation at
the 59th
annual meeting of the American Society for Hematology
(ASH).
Patients
were enrolled in DREAMM-1 independent of BCMA expression levels.
The study participants were heavily pre-treated, with 57% of the
patients having at least five prior lines of treatment and 40%
having prior daratumumab treatment. The most commonly reported
adverse events were corneal events (63%) and thrombocytopenia
(57%); no dose-limiting toxicities were reported. Infusion-related
reactions (IRRs) occurred in 23% of patients (without
pre-medication) on the first infusion and no IRRs occurred on
subsequent infusions.
Axel
Hoos, SVP Oncology R&D, GSK said "The patients participating in
the DREAMM-1 trial had very limited options for further treatment,
so we are encouraged by the response rate seen in this trial.
GSK2857916 is the leading asset in our emerging pipeline of
potentially transformative Oncology medicines and we plan to
rapidly progress its development programme, initiating pivotal
monotherapy studies as well as new combination studies in
2018."
Multiple
myeloma is the second most common blood cancer in the United
Statesi
and is generally considered treatable but not curable.
Multiple myeloma commonly becomes refractory to available
treatments, so research into new treatments is vital.
GSK2857916 was recently awarded Breakthrough Therapy designation
from the US Food and Drug Administration and PRIME designation from
the European Medicines Agency; these designations are intended to
facilitate development of investigational medicines that have shown
clinical promise for conditions where there is significant unmet
need.
The DREAMM -1 study is a first-in-human, open-label study of
GSK2857916 in patients with relapsed/ refractory multiple myeloma.
The primary objective is safety; response rate, pharmacokinetics
and immunogenicity are secondary endpoints. The study consists of
two parts: a dose escalation
phase in which patients
received GSK2857916 at escalating doses and a dose expansion
phase in which all patients
received GSK2857916 at the recommended phase II dose. Results from
the dose escalation phase of the study were presented at ASH
2016ii
GSK in Oncology
GSK is focused on delivering transformational therapies for cancer
patients. GSK's pipeline is focused on immuno-oncology, cell
therapy, and epigenetics. Our goal is to achieve a sustainable flow
of new treatments for cancer patients based on a diversified
portfolio of investigational medicines utilising modalities such as
small molecules, antibodies, multi-specific molecules, adjuvants
and cells, either alone or in combination.
The
data presented at ASH show important R&D progress in GSK's
Oncology pipeline. The company has also strengthened its
commercial and R&D interface within Oncology through the recent
appointment of Christine Roth as Oncology Franchise Head, who will
be responsible for shaping the commercial and global product
strategy for GSK's innovative pipeline of Oncology
assets.
In 2015 GSK divested its Oncology business for an aggregate cash
consideration of $16 billion, while retaining its portfolio of
early stage Oncology assets. Novartis has a right of first
negotiation (ROFN) that is triggered upon a decision to seek a
partner or divest certain Oncology assets or if GSK proposes to
seek a marketing authorisation for such Oncology assets, on an
asset by asset basis. The ROFN does not oblige GSK to sell
to, or partner with, Novartis. Novartis does not have an
"opt-in" or a "call" option related to GSK's Oncology pipeline.
Under the ROFN, GSK is able to continue to develop and
commercialise assets on its own. GSK's obligation is to
negotiate in good faith. GSK would only enter into a
transaction if GSK believes it was in the best interest of its
shareholders. The ROFN extends for 12.5 years from closing;
i.e. September 2027.The complete contractual terms of the ROFN are
available at https://www.sec.gov/Archives/edgar/data/1131399/000119312516510261/d32974dex410.htm
Conference call for investors and analysts
GSK
will host a conference call for investors and analysts at 18:00
GMT/ 1:00PM EST on Tuesday, 12 December 2017.
Notes to Editors
About the DREAMM -1 study (NCT02064387)
The study is an open-label, dose escalation study to investigate
the safety, pharmacokinetics, pharmacodynamics, immunogenicity and
clinical activity of the antibody drug conjugate GSK2857916 in
subjects with relapsed/refractory multiple myeloma and other
advanced haematologic malignancies expressing BCMA.
The study consists of two parts:1) a dose escalation phase and 2)
an expansion phase for safety, tolerability, PK, PD, and clinical
activity testing. The study will enrol a total of approximately
80-95 subjects with relapsed/refractory MM or BCMA-expressing
hematologic malignancies. The maximum dose to be administered in
this trial will not exceed 5 mg/kg.
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 and APRIL. 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 linesiii.
About GSK2857916:
GSK2857916 is an 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 technology licensed
from BioWa.
GSK2857916 is currently in phase I clinical development
(NCT02064387) in patients with relapsed/refractory multiple myeloma
and other advanced haematologic malignancies expressing
BCMA.
GSK2857916 is not approved for use anywhere in the
world
GSK - GSK - 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
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GSK enquiries:
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UK
Media enquiries:
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David
Mawdsley
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+44 (0)
20 8047 5502
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(London)
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Simon
Steel
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+44 (0)
20 8047 5502
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(London)
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David
Daley
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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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Sarah
Alspach
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+1 202
715 1048
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(Washington,
DC)
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Sarah
Spencer
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+1 215
751 3335
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(Philadelphia)
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Mary
Anne Rhyne
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+1 919
483 0492
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(North
Carolina)
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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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Tom
Curry
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+ 1 215
751 5419
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(Philadelphia)
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Gary
Davies
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+44 (0)
20 8047 5503
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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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Cautionary statement regarding forward-looking statementsGSK
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 2016.
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Registered in England & Wales:
No. 3888792
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Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS
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i https://www.cancer.net/cancer-types/multiple-myeloma/statistics
Last
accessed December 2017
iiAdam
D. Cohen, Rakesh Popat, Suzanne Trudel, Paul
G Richardson, Ed
N. Libby III, Nikoletta Lendvai, Larry
D. Anderson Jr., HeatherSutherland, Stephen DeWall, Catherine Ellis, Zangdong He, Jolly Mazumdar, Catherine Wang, Joanna
B. Opalinska and Peter M. Voorhees. First in
Human Study with GSK2857916, an Antibody Drug Conjugated to
Microtubule-Disrupting Agent Directed Against B-Cell Maturation
Antigen (BCMA) in Patients with Relapsed/Refractory Multiple
Myeloma (MM): Results from Study BMA117159 Part 1 Dose Escalation.
Blood 2016;
128(22):1148
iii 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
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: December
12, 2017
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By: 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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