Issued: 9 December 2024, London
UK
Blenrep
(belantamab
mafodotin) combination accepted for priority review in China in
relapsed/refractory multiple myeloma
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Regulatory submission supported by
phase III head-to-head DREAMM-7 trial showing statistically
significant efficacy, including overall survival
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If approved, Blenrep combination could redefine
multiple myeloma treatment at or after first relapse
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Seventh major regulatory filing
acceptance this year for belantamab mafodotin combinations in this
indication, following US filing acceptance based on DREAMM-7 and
DREAMM-8
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GSK plc (LSE/NYSE: GSK) today
announced that the National Medical Products Administration (NMPA)
of China has accepted for review a new drug application (NDA) for
Blenrep (belantamab
mafodotin) in combination with bortezomib plus dexamethasone (BVd)
as a treatment for relapsed or refractory multiple myeloma. Earlier
this year, the NMPA granted priority review for this application as
well as
Breakthrough Therapy Designation[1] for the BVd combination, which
is intended to expedite development of investigational drugs with
potential for substantial improvement over available
therapies.[2]
Hesham Abdullah, Senior Vice President, Global Head Oncology,
R&D, GSK, said: "Today's
regulatory filing acceptance, with a priority review, is a
meaningful step forward in our efforts to bring the benefits of
Blenrep in combination to
patients in China. Multiple myeloma patients need new options that
may improve outcomes, particularly at first relapse. The
DREAMM-7 trial shows statistically significant
efficacy, including overall survival and could redefine treatment
in this patient population."
This is the seventh major regulatory
filing acceptance this year for belantamab mafodotin in combination
for 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
US[3],
European Union[4],
Japan[5] (with
priority review), United Kingdom, Canada and Switzerland (with
priority review for DREAMM-8).
The application is based on the
interim results of the phase III head-to-head DREAMM-7 trial, which
met its primary endpoint, showing statistically significant and
clinically meaningful improvement in progression-free survival
(PFS) for BVd compared to daratumumab plus bortezomib and
dexamethasone (DVd) in relapsed or refractory multiple myeloma. In
a subsequent planned interim analysis, the DREAMM-7 trial met the
key secondary endpoint of overall survival (OS), showing that BVd
significantly reduced the risk of death versus standard of care
DVd.
About multiple myeloma
Multiple myeloma is the third most
common blood cancer globally and is generally considered treatable
but not curable.[6],[7] There are approximately more than 180,000
new cases of multiple myeloma diagnosed globally each
year.[8] In China,
multiple myeloma is a growing health
concern with approximately 30,000 new cases each year.[9] The incidence of multiple
myeloma in China has doubled and mortality has increased 1.5-fold
in the past three decades.[10] Research into new therapies is needed as multiple myeloma
commonly becomes refractory to available treatments.[11]
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[12] 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 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 GSKs Q3 Results for
2024.
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