Blueprint
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 21 March
2019
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: 21 March 2019, London UK - LSE Announcement
GSK announces further positive data from DREAMM-1 study of
anti-BCMA antibody-drug conjugate in patients with
relapsed/refractory multiple myeloma
Median progression-free survival
extends to twelve months
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced further
positive data from the DREAMM-1 study of patients with
relapsed/refractory multiple myeloma who received GSK2857916, an
investigational anti-B-cell maturation antigen (BCMA) antibody-drug
conjugate. These results, published in Blood Cancer
Journal (link)
build upon results from the pre-specified interim analysis, which
were first presented at the American Society of Haematology
Congress in 2017.
These new data confirm that 60% of patients receiving GSK2857916
achieved an overall response rate (ORR). This ORR was
identical to the rate previously reported in the interim analysis,
after more than a year of follow-up, and demonstrates not only the
potential efficacy of the medicine but the durability and depth of
response. The number of patients achieving a complete response
increased to 15% over this additional one year follow-up period.
The median progression-free survival (PFS) was 12 months (95% CI
[3.1-Not Estimable/NE]), an increase from the previously reported
7.9 months PFS. The median duration of response in the final
analysis was 14.3 months (95% CI [10.6-NE]). All patients whose
data were reported in the interim analysis were included in this
analysis.
Dr Hal Barron, Chief Scientific Officer and President, R&D,
GSK, commented, "These data are very encouraging and I am excited
by what they could mean for people living with multiple
myeloma. We are aggressively advancing this potential new
medicine and plan to have pivotal data to support its filing by the
end of this year."
A total of 35 patients were enrolled in Part 2 of the DREAMM-1
study independent of their BCMA expression levels. Amongst those
heavily pre-treated patients not previously treated with the
anti-CD38 monoclonal antibody, daratumumab, the ORR was 71% (95% CI
[47.8%,88.7%]) with a mPFS of 15.7 months, (95% CI [2.3-NE]). In
those patients who had previously been treated with daratumumab,
the ORR was 38.5%; (95% CI [13.9-68.4]) with a mPFS of 7.9 months
(95% CI [2.3-NE]).
No new safety signals were identified during this treatment
period. The most commonly reported adverse events were
thrombocytopenia (63%), blurred vision (51%), cough (40%), which
were mostly mild or moderate (Grade 1 or 2). The most commonly
reported Grade 3 or 4 adverse events were thrombocytopenia (35%)
and anemia (17%) and were found to be manageable.
Paul Giusti, President and Chief Executive Officer of the Multiple
Myeloma Research Foundation (MMRF), said, "Significant advancements
have been made in our knowledge, understanding and the treatment of
multiple myeloma in the past decade, but there is so much more that
we as a community need to do to accelerate better outcomes and
quality of life for patients. Relapses are particularly
challenging, so the need for treatment advances is a priority at
the MMRF to ensure our patients can benefit from them in the
future. We are encouraged by the results from this early
study, and we look forward to seeing additional data later this
year."
Multiple myeloma is the second most common blood cancer in the
United States[i] and is generally considered treatable but not
curable. Multiple myeloma commonly becomes refractory to available
treatments, so research into new treatments is vital.
In 2017, GSK2857916 was awarded Breakthrough Therapy designation
from the U.S. 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.
About the DREAMM-1 study (NCT02064387)
DREAMM-1 is a first-in-human, open-label study of GSK2857916 to
investigate the safety, pharmacokinetics, pharmacodynamics,
immunogenicity and clinical activity of the antibody drug conjugate
GSK2857916 in patients with relapsed/refractory multiple myeloma
and other advanced haematologic malignancies expressing BCMA. The
primary objective is safety; additional objectives include:
response rate, pharmacokinetics and immunogenicity. 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
2 dose.
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 lines[iii].
About the DREAMM Clinical Trial Programme for GSK2857916
(GSK'916)
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.
GSK'916 is currently in clinical development in patients with
relapsed/refractory multiple myeloma and other advanced
haematologic malignancies expressing BCMA.
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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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DREAMM-2
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205678/NCT03525678
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Ongoing;
recruitment complete
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A Study
to Investigate the Efficacy and Safety of Two Doses of GSK'916 in
Subjects With Multiple Myeloma Who Have Failed Prior Treatment With
an Anti-CD38 Antibody
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DREAMM-3
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207495
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Planned
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A Phase
III Open-Label, Randomized Study to Evaluate the Efficacy and
Safety of GSK'916 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 GSK'916 Administered in Combination With Pembrolizumab
in Subjects With Relapsed/Refractory Multiple Myeloma
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DREAMM-5
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208887
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Planned
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A Phase
I/II, Randomized, Open-label Platform Study of GSK'916 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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Evaluate
Safety, Tolerability, and Clinical Activity of GSK'916 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
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Planned
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Phase
III study of GSK'916, bortezomib, and 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, Multicenter, Open-Label, Randomized Study to Evaluate the
Efficacy and Safety of GSK'916 in Combination with Pomalidomide and
Low-Dose Dexamethasone (GSK'916+Pd) 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
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Planned
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A phase
III study of GSK916 + Standard of Care (SOC) vs. SOC in first line
transplant ineligible multiple myeloma patients
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DREAMM-10
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207500
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Planned
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'916+novel
agent vs SOC
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GSK2857916 is not currently approved for use anywhere in the
world.
GSK in Oncology
GSK is focused on delivering transformational therapies for people
living with cancer. GSK's pipeline is focused on immuno-oncology,
cell therapy and cancer epigenetics. 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 December 2018.
[ii]Adam 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
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GSK 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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Mary
Anne Rhyne
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+1
(919) 412-9089
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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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Danielle
Smith
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+44 (0)
20 8047 2406
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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
|
(Philadelphia)
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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: March
21, 2019
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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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