- Belantamab mafodotin accepted for accelerated assessment
by the EMA's Committee for Human Medicinal Products (CHMP)
- Submission based on data from the pivotal DREAMM-2 study
of immunoconjugate targeting B-cell maturation antigen (BCMA)
recently published in The Lancet Oncology
LONDON, Feb. 3, 2020 /PRNewswire/ -- GlaxoSmithKline plc
today announced that the European Medicines Agency (EMA) validated
the marketing authorisation application (MAA) for belantamab
mafodotin for the treatment of patients with relapsed or refractory
multiple myeloma whose prior therapy included an immunomodulatory
agent, a proteasome inhibitor and an anti-CD38 antibody. Belantamab
mafodotin was accepted for accelerated assessment by the EMA's
Committee for Human Medicinal Products (CHMP).
Accelerated assessment is granted if the CHMP determines the
treatment is of major interest from a public health perspective and
represents a therapeutic innovation. Validation of the MAA confirms
that the submission is accepted and begins the formal review
process by the CHMP.
The MAA is based on data from the pivotal DREAMM-2 (DRiving
Excellence in Approaches to Multiple Myeloma) study. Full results
from the study, recently published in The Lancet
Oncology, demonstrated a 31% overall response rate (ORR) with a
2.5 mg/kg regimen of single-agent belantamab mafodotin in heavily
pre-treated patients with multiple myeloma who were refractory to
an immunomodulatory drug and a proteasome inhibitor and were
refractory and/or intolerant to an anti-CD38 antibody. The safety
and tolerability profile was consistent with previously reported
data on belantamab mafodotin.i
More than 48,000 people in the European Union were diagnosed
with multiple myeloma in 2018.ii Belantamab
mafodotin was granted PRIME designation in 2017 by the EMA, a
programme that is intended to facilitate development of
investigational medicines that have shown clinical promise for
conditions where there is significant unmet need.
About multiple myeloma
Multiple myeloma is the second
most common blood cancer and is generally considered treatable, but
not curable.iii Research into new therapies is
needed as multiple myeloma commonly becomes refractory to available
treatments.iv
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.v
About the DREAMM clinical trial programme for belantamab
mafodotin (GSK2857916)
Belantamab mafodotin is an investigational immunoconjugate
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
ID
|
Status
|
Design
|
|
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
recruiting
|
A Phase II Study to
Investigate 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
|
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/
NCT04126200
|
Recruiting
|
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/ 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 Study
|
209418/ NCT03715478
|
Recruiting
|
A Phase I/II
Dose-escalation 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
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/about-us.
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 'Principal risks and uncertainties' in the company's Annual
Report on Form 20-F for 2018.
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References
i Lonial, S, et al. Belantamab mafodotin for
relapsed or refractory multiple myeloma (DREAMM-2): a two-arm,
randomised, open-label, phase 2 study. Lancet Oncol. 2020;
21(2):207–21.
ii World Health Organization: International Agency for
Research on Cancer (IACR). Estimated number of incident cases from
2018 to 2040, multiple myeloma, both sexes, all ages, Europe. Available at: http://gco.iarc.fr/.
Accessed December 18, 2019.
iii Kazandjian D. Multiple myeloma epidemiology and
survival: A unique malignancy. Semin Oncol. 2016;43(6):676–681.
doi:10.1053/j.seminoncol.2016.11.004.
iv Nooka AK, Kastritis E, Dimopoulos MA. Treatment
options for relapsed and refractory multiple myeloma. Blood.
2015;125(20)
v Carpenter RO, Evbuomwan MO et al. B-cell maturation
antigen is a promising target for adoptive T-cell therapy of
multiple myeloma. Clin Cancer
Res. 2013 Apr 15;19(8):2048-60.