TIDMGSK
RNS Number : 6374T
GlaxoSmithKline PLC
21 March 2019
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.
Trial Name GSK ID/NCT Status Design
ID
DREAMM-1 117159/ NCT02064387 Completed
-------------------- ------------- ----------------------------------------------
DREAMM-2 205678/ NCT03525678 Ongoing; A Study to Investigate the Efficacy
recruitment and Safety of Two Doses of GSK'916
complete in Subjects With Multiple Myeloma
Who 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 GSK'916 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 GSK'916 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 GSK'916 with
Innovative Combination Anti-Cancer
Treatments in Participants with
Relapsed/Refractory Multiple Myeloma
-------------------- ------------- ----------------------------------------------
DREAMM-6 207497/ NCT03544281 Recruiting 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
-------------------- ------------- ----------------------------------------------
DREAMM-7 207503 Planned Phase III study of GSK'916, bortezomib,
and dexamethasone versus daratumumab,
bortezomib, and dexamethasone
in participants with relapsed/refractory
multiple myeloma
-------------------- ------------- ----------------------------------------------
DREAMM-8 207499 Planned 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
-------------------- ------------- ----------------------------------------------
DREAMM-9 209664 Planned A phase III study of GSK916 +
Standard of Care (SOC) vs. SOC
in first line transplant ineligible
multiple myeloma patients
-------------------- ------------- ----------------------------------------------
DREAMM-10 207500 Planned '916+novel agent vs SOC
-------------------- ------------- ----------------------------------------------
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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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.
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