TIDMGSK
RNS Number : 0567U
GlaxoSmithKline PLC
24 July 2020
Issued: 24 July 2020, London UK
GSK receives positive CHMP opinion recommending approval of
belantamab mafodotin for the treatment of relapsed and refractory
multiple myeloma
GlaxoSmithKline plc ( LSE/NYSE: GSK) today announced the
Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) adopted a positive opinion
recommending the approval of belantamab mafodotin as monotherapy
for the treatment of multiple myeloma in adult patients, who have
received at least four prior therapies and whose disease is
refractory to at least one proteasome inhibitor, one
immunomodulatory agent, and an anti-CD38 monoclonal antibody, and
who have demonstrated disease progression on the last therapy.
Dr Axel Hoos, Senior Vice President and Head of Oncology
R&D, GSK said: "Today's positive opinion from the CHMP is an
important step in helping patients suffering from relapsed or
refractory multiple myeloma who currently have limited options and
poor outcomes. If approved, belantamab mafodotin will provide
patients and physicians across much of Europe with a first-in-class
anti-BCMA treatment option that works differently from other
available therapies for this incurable disease."
Belantamab mafodotin was granted PRIME designation in 2017 and
the Conditional Marketing Authorisation Application (CMAA) was
reviewed under EMA's accelerated assessment procedure, which is
given if the CHMP determines the treatment is of major interest
from a public health perspective and represents a therapeutic
innovation. The CHMP positive opinion is one of the final steps
before marketing authorisation is granted by the European
Commission, which has the authority to approve medicines for use
throughout the European Union. If approved, belantamab mafodotin
will be marketed as BLENREP and will be the second major regulatory
milestone for GSK's oncology portfolio this year.
The CMAA is based on data from the pivotal DREAMM-2 (DRiving
Excellence in Approaches to Multiple Myeloma) study including
13-month follow-up data. These data demonstrated that treatment
with single-agent belantamab mafodotin, administered as a 2.5 mg/kg
dose every three weeks (Q3W), resulted in an overall response rate
of 32%. Median duration of response was 11 months and median
overall survival was 13.7 months.
The safety and tolerability profile were consistent with
previously reported data on belantamab mafodotin. The most commonly
reported grade 3 or higher adverse events (occurring in more than
10% of patients) in patients receiving the 2.5 mg/kg dose were
keratopathy/microcyst-like epithelial changes (MECs) (46%),
thrombocytopenia (22%), anaemia (21%), lymphocyte count decreased
(13%) and neutropenia (11%).
Belantamab mafodotin is also under review by the US Food and
Drug Administration which granted a priority review for the
company's Biologics License Application (BLA).
About DREAMM-2
DREAMM-2 is an open label study of belantamab mafodotin.
Patients in the trial had actively progressing multiple myeloma
that had worsened despite current standard of care and were
randomised to two arms to receive either 2.5 mg/kg or 3.4 mg/kg
belantamab mafodotin Q3W. Overall, patients in DREAMM-2 had more
advanced disease, poorer prognosis and performance status and also
had a greater number of prior lines of therapy in comparison with
patients in DREAMM-1, the first time in human study of belantamab
mafodotin.
About multiple myeloma
Multiple myeloma is the third most common blood cancer worldwide
and is generally considered treatable, but not curable. ([i])
Research into new therapies is needed as multiple myeloma commonly
becomes refractory to available treatments. ([ii])
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 belantamab mafodotin (GSK2857916)
Belantamab mafodotin is an investigational 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 POTELLIGENT Technology licensed from BioWa.
Belantamab mafodotin is not currently approved for use anywhere
in the world.
Trial Name GSK ID/NCT Status Design
ID
DREAMM-1 117159/ NCT02064387 Completed A Phase I Open-label Study
to Investigate the Safety,
Pharmacokinetics, Pharmacodynamics,
Immunogenicity and Clinical
Activity of Belantamab
Mafodotin (GSK2857916)
in Subjects with Relapsed/Refractory
Multiple Myeloma and Other
Advanced Hematologic Malignancies
Expressing BCMA
-------------------- ------------ ------------------------------------------
DREAMM-2 205678/ NCT03525678 Active, not A Phase II Study to Investigate
recruiting 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/ NCT04162210 Recruiting 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/ Recruiting A Phase I/II, Randomized,
NCT04126200 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/ Recruiting A Phase III Study of Belantamab
NCT04246047 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/ NCT04091126 Recruiting 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 209418/ NCT03715478 Recruiting A Phase I/II Dose-escalation
Study 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
-------------------- ------------ ------------------------------------------
GSK in Oncology
GSK is focused on maximising 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
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purpose: to help people do more, feel better, live longer. For
further information please visit www.gsk.com/about-us .
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Cautionary statement 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
"Risk Factors" in the company's Annual Report on Form 20-F for 2019
and any impacts of the COVID-19 pandemic.
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[i] Estimated number of incident cases worldwide, both sexes,
all ages. World Health Organization.
https://gco.iarc.fr/ Published 2020. Accessed May 2020 .
[ii] Nooka A, Kastritis E, Dimopoulos M, Lonial S. Treatment
options for relapsed and refractory multiple myeloma. Blood.
2015;125(20):3085-3099. doi:10.1182/blood-2014-11-568923.
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END
MSCLZLFLBDLFBBZ
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July 24, 2020 08:16 ET (12:16 GMT)
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