- Biologics License Application based on results from the pivotal
DREAMM-2 study of immunoconjugate targeting B-cell maturation
antigen (BCMA) in heavily pre-treated patient population who was
refractory to an immunomodulatory drug and a proteasome inhibitor,
and refractory or intolerant to an anti-CD38 antibody
- Belantamab mafodotin has potential to be the first anti-BCMA
treatment available to patients
LONDON, Jan. 21, 2020 /CNW/ -- GlaxoSmithKline plc
(LSE/NYSE: GSK) announced the US Food and Drug Administration (FDA)
granted a priority review for the company's Biologics License
Application (BLA) seeking approval of belantamab mafodotin
(GSK2857916) 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.
The BLA is based on data from the pivotal DREAMM-2 (DRiving
Excellence in Approaches to Multiple Myeloma) study, recently
published in The Lancet Oncology, which enrolled heavily
pre-treated patients who had actively progressing multiple myeloma
that had worsened despite current standard of care.i
In 2017, belantamab mafodotin was granted Breakthrough Therapy
designation by the FDA, which is intended to facilitate the
development of investigational medicines that have shown clinical
promise for conditions where there is significant unmet need.
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 multiple myeloma
Multiple myeloma is the second
most common blood cancer and is generally considered treatable, but
not curable.iii In the US, more than 32,000 people were
diagnosed with multiple myeloma last year and nearly 13,000 people
died from the disease.iv Research into new therapies is
needed as multiple myeloma commonly becomes refractory to available
treatments.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/
NCT04162210
|
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.
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.
Registered in England &
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Registered Office:
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TW8 9GS
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. The
Lancet Oncology. Epub ahead of print.
ii 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.
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 SEER Cancer Facts & Figures 2019. Available
at: https://seer.cancer.gov/statfacts/html/mulmy.html. Accessed
December 19, 2019.
v Nooka AK, Kastritis E, Dimopoulos MA. Treatment
options for relapsed and refractory multiple myeloma. Blood.
2015;125(20)
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content:http://www.prnewswire.com/news-releases/us-food-and-drug-administration-fda-grants-priority-review-of-belantamab-mafodotin-for-patients-with-relapsed-or-refractory-multiple-myeloma-300990248.html
SOURCE GlaxoSmithKline plc