GlaxoSmithKline PLC GSK - positive results from pivotal DREAMM-2 study (0425K)
August 23 2019 - 2:00AM
UK Regulatory
TIDMGSK
RNS Number : 0425K
GlaxoSmithKline PLC
23 August 2019
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 Status Design
ID
DREAMM-1 117159/ NCT02064387 Active, A Phase I Open-label Study to
not recruiting 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, A Study to Investigate the Efficacy
not recruiting 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 209418 Recruiting A Phase I/II Dose-escalation
Co-Sponsored and Dose-expansion Study of
Study 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
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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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