Issued: 25 November 2024, London
UK
Blenrep
combinations
accepted for review by the US FDA for the treatment of
relapsed/refractory multiple myeloma
· Regulatory submission supported by phase III head-to-head
DREAMM-7 and DREAMM-8 trials showing statistically significant
efficacy, including overall survival in DREAMM-7
· If approved, Blenrep
(belantamab mafodotin) in combinations with BorDex (BVd) and PomDex
(BPd) could redefine multiple myeloma treatment at or after first
relapse
· Sixth major regulatory filing acceptance this year for
belantamab mafodotin combinations in this indication
· US decision expected by 23 July 2025
GSK plc (LSE/NYSE: GSK) today
announced the US Food and Drug Administration (FDA) has accepted
for review a Biologics License Application (BLA) for Blenrep (belantamab mafodotin) in
combinations with bortezomib plus dexamethasone (BorDex [BVd]) and
pomalidomide plus dexamethasone (PomDex [BPd]) for the treatment of
patients with multiple myeloma who have received at least one prior
line of therapy. The US FDA has assigned a Prescription Drug User
Fee Act action date of 23 July 2025.
Hesham Abdullah, Senior Vice President, Global Head Oncology,
R&D, GSK, said:
"Relapsed/refractory multiple myeloma treatment could be
transformed by additional, efficacious treatment options with
manageable side effects and community-based administration. The
evidence from DREAMM-7 and DREAMM-8 supporting our Blenrep combinations submission has
been further strengthened by the statistically significant overall
survival results from the DREAMM-7 trial. We look forward to
working with the FDA on this review."
The US application is based on
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 triplet combinations in relapsed or refractory
multiple myeloma.
Results from both trials 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 the DREAMM-7 and DREAMM-8 trials were broadly
consistent with the known profiles of the individual
agents.
In a subsequent planned interim
analysis, the DREAMM-7 trial also met the key secondary endpoint
of
overall survival[1] (OS), showing a statistically significant and clinically
meaningful OS benefit favouring the belantamab mafodotin
combination. Efficacy and safety data from this analysis will be
presented at the upcoming 66th American Society of Hematology (ASH)
Annual Meeting and Exposition on 9 December 2024 at 11:15 a.m. PT.
A positive trend in OS was observed in DREAMM-8 but was not
statistically significant at the time of interim analysis, and
follow-up for OS continues.
This is the sixth major regulatory
filing acceptance this year for belantamab mafodotin combinations
in the treatment of relapsed or refractory multiple myeloma
based on the results of the DREAMM-7 and DREAMM-8
trials. In 2024,
belantamab mafodotin combinations have been accepted for review in
the
European Union[2],
Japan[3] (with
priority review), United Kingdom, Canada and Switzerland (with
priority review for DREAMM-8). In
China[4], the National Medical Products Administration has granted
Breakthrough Therapy Designation for belantamab mafodotin in
combination with bortezomib and dexamethasone, as well as priority
review for the regulatory application based on the results of
DREAMM-7.
About multiple myeloma
Multiple myeloma is the third most
common blood cancer globally and is generally considered treatable
but not curable.[5],[6] There are approximately more than 180,000
new cases of multiple myeloma diagnosed globally each
year.[7] Multiple myeloma is a
significant and enduring health concern in the US, where more than
35,000 cases are expected to be diagnosed in
2024.6,[8] Research into new
therapies is needed as multiple myeloma commonly becomes refractory
to available treatments.[9]
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 bortezomib plus dexamethasone
(BVd) compared to a combination of daratumumab
and bortezomib plus dexamethasone (DVd) 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 BVd or DVd. 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[10] 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 pomalidomide plus dexamethasone
(BPd) compared to a combination of bortezomib
and pomalidomide plus dexamethasone (PVd)
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, 78% 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 BPd or PVd.
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[11] 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.
Blenrep is approved as
monotherapy in Hong Kong. Refer to the local Summary of Product
Characteristics for a full list of adverse events and complete
important safety information.
GSK
in oncology
Oncology is an emerging therapeutic
area for GSK where we are committed to maximising patient survival
with a current focus on haematologic malignancies, gynaecologic
cancers, and other solid tumours through breakthroughs in
immuno-oncology and tumour-cell targeting therapies.
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
"Risk factors" in GSK's Annual Report on Form 20-F for 2023, and
GSK's Q3 Results for 2024.
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