Issued: 19 July 2024, London
UK
Blenrep
(belantamab
mafodotin) combinations in multiple myeloma application accepted
for review by the European Medicines Agency
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Regulatory submission supported by
phase III head-to-head DREAMM-7 and DREAMM-8 trials
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Trials showed significant
progression-free survival benefit and positive overall survival
trends for Blenrep
combinations versus standard of care
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If approved, Blenrep plus BorDex or PomDex could
redefine the relapsed/refractory multiple myeloma treatment
landscape
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GSK plc (LSE/NYSE: GSK) today
announced that the European Medicines Agency (EMA) has accepted the
marketing authorisation application (MAA) for Blenrep (belantamab mafodotin) in
combination with bortezomib plus dexamethasone (BorDex) or
pomalidomide plus dexamethasone (PomDex) as a treatment for
relapsed or refractory multiple myeloma. The EMAÕs Committee for
Medicinal Products for Human Use (CHMP) will begin the formal
review process to make a recommendation to the European Commission
regarding this potential authorisation.
Hesham Abdullah, Senior Vice President, Global Head Oncology,
R&D, GSK, said: ÒTodayÕs
milestone reinforces the potential for Blenrep to redefine outcomes for
patients with multiple myeloma at or after first relapse. We are
working to bring Blenrep
to patients as quickly as possible given the high unmet need and
the clinically robust effects of the Blenrep combinations in the DREAMM-7
and DREAMM-8 phase III head-to-head trials.Ó
The application is based on interim
results from the DREAMM-7 and DREAMM-8 phase III trials, which both
met their primary endpoints, showing statistically significant and
clinically meaningful improvements in progression-free survival
(PFS) for the belantamab mafodotin combinations compared to
standard of care combinations in relapsed or refractory multiple
myeloma. The DREAMM-7 trial is evaluating belantamab mafodotin
combined with BorDex versus daratumumab plus BorDex, while the
DREAMM-8 trial is evaluating belantamab mafodotin in combination
with PomDex versus bortezomib plus PomDex.
A positive overall survival (OS)
trend was observed in both trials but was not statistically
significant at the time of interim analysis. Follow-up for OS
continues. Results also showed clinically meaningful improvements
across all other secondary efficacy endpoints, including deeper and
more durable responses compared to the respective standard of care
combinations. The safety and tolerability profiles of the
belantamab mafodotin combinations in DREAMM-7 and DREAMM-8 trials
were broadly consistent with the known profiles of the individual
agents.
About multiple myeloma
Multiple myeloma is the third most
common blood cancer globally and is generally considered treatable
but not curable.[1],[2] There are approximately more than 180,000
new cases of multiple myeloma diagnosed globally each year,
including approximately 50,000 new cases in Europe.[3],[4] Research into new therapies is needed
as multiple myeloma commonly becomes refractory to available
treatments.[5]
About DREAMM-7
The DREAMM-7 phase III clinical trial
is a multicentre, open-label, randomised trial evaluating the
efficacy and safety of belantamab mafodotin in combination with
BorDex compared to a combination of daratumumab and BorDex in
patients with relapsed/refractory multiple myeloma who previously
were treated with at least one prior line of multiple myeloma
therapy, with documented disease progression during or after their
most recent therapy.
A total of 494 participants were
randomised at a 1:1 ratio to receive either belantamab mafodotin in
combination with BorDex or a combination of daratumumab and BorDex.
Belantamab mafodotin was scheduled to be dosed at 2.5mg/kg
intravenously every three weeks.
The primary endpoint is PFS as per an
independent review committee. The key secondary endpoints include
OS, duration of response (DOR), and minimal residual disease (MRD)
negativity rate as assessed by next-generation sequencing. Other
secondary endpoints include overall response rate (ORR), safety and
patient reported and quality of life outcomes.
Results from DREAMM-7 were
first
presented[6] at the
American Society of Clinical Oncology (ASCO) Plenary Series in
February 2024, shared in an encore presentation at the 2024 ASCO
Annual Meeting, and published in the New England Journal of
Medicine.
About DREAMM-8
The DREAMM-8 phase III clinical trial
is a multicentre, open-label, randomised trial evaluating the
efficacy and safety of belantamab mafodotin in combination with
PomDex compared to a combination of bortezomib and PomDex in
patients with relapsed/refractory multiple myeloma previously
treated with at least one prior line of multiple myeloma therapy,
including a lenalidomide-containing regimen, and who have
documented disease progression during or after their most recent
therapy. Compared to the patient population studied in the DREAMM-7
trial, patients in DREAMM-8 were more heavily pre-treated in that
all had prior exposure to lenalidomide, 75% were refractory to
lenalidomide, 25% had prior daratumumab exposure and of those most
were daratumumab refractory.
A total of 302 participants were
randomised at a 1:1 ratio to receive either belantamab mafodotin
plus PomDex, or bortezomib plus PomDex.
The primary endpoint is PFS as per an
independent review committee. The key secondary endpoints include
OS and MRD negativity rate as assessed by next-generation
sequencing. Other secondary endpoints include ORR, DOR, safety and
patient reported and quality of life outcomes.
Results from DREAMM-8 were
first
presented[7] at the
2024 ASCO Annual Meeting and published in the New England Journal of
Medicine.
About Blenrep
Blenrep is an
antibody-drug conjugate comprising a humanised B-cell maturation
antigen monoclonal antibody conjugated to the cytotoxic agent
auristatin F via a non-cleavable linker. The drug linker technology
is licensed from Seagen Inc.; the monoclonal antibody is produced
using POTELLIGENT Technology licensed from BioWa Inc., a member of
the Kyowa Kirin Group.
Refer to the Blenrep UK Summary
of Product Characteristics[8] for a full list of adverse
events and the complete important safety information in the United
Kingdom.
GSK
in oncology
GSK is committed to maximising
patient survival through transformational medicines, with a current
focus on breakthroughs in immuno-oncology and tumour-cell targeting
therapies, and development in haematologic malignancies,
gynaecologic cancers, and other solid tumours.
About GSK
GSK is a global biopharma company
with a purpose to unite science, technology, and talent to get
ahead of disease together. Find out more at gsk.com.
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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 ÒRisk factorsÓ in GSKÕs
Annual Report on Form 20-F for 2023, and GSKÕs Q1 Results for
2024.
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