Issued: 14 November 2024, London
UK
Blenrep
shows overall
survival benefit in head-to-head DREAMM-7 phase III trial for
relapsed/refractory multiple myeloma
· Statistically significant and clinically meaningful reduction
in the risk of death seen with Blenrep (belantamab mafodotin) plus
bortezomib and dexamethasone (BorDex) versus daratumumab plus
BorDex
· Full data to be presented at 2024 American Society of
Hematology Annual Meeting in December
· Data to be shared with health authorities to support
regulatory filings
GSK plc (LSE/NYSE: GSK) today announced
positive headline results from a planned interim
analysis of the DREAMM-7 head-to-head phase III trial
evaluating Blenrep (belantamab mafodotin)
in combination with bortezomib plus dexamethasone (BorDex)
as a second-line or later treatment for relapsed
or refractory multiple myeloma. The trial met the key secondary
endpoint of overall survival (OS), showing that belantamab
mafodotin when combined with BorDex significantly reduced the risk
of death versus standard of care daratumumab plus BorDex.
Hesham Abdullah, Senior Vice President, Global Head Oncology,
R&D, GSK, said: "The overall
survival results from the DREAMM-7 trial underscore the potential
for this Blenrep
combination to extend the lives of patients with
relapsed/refractory multiple myeloma. This is a statistically
significant and clinically meaningful advancement for patients and
potentially transformative for treatment. We look forward to
sharing these data with health authorities and presenting the full
results at next month's American Society of Hematology Annual
Meeting."
Results from the interim analysis,
including safety data, 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.
The DREAMM (DRiving Excellence in
Approaches to Multiple Myeloma) clinical development programme
continues to evaluate the potential of belantamab mafodotin in
early lines of treatment and in combination with novel therapies
and standard of care treatments. In addition to DREAMM-7, this
includes the ongoing head-to-head phase III DREAMM-8 trial
evaluating belantamab mafodotin in combination with pomalidomide
and dexamethasone versus bortezomib in combination with
pomalidomide and dexamethasone.
A phase III study in newly diagnosed
transplant ineligible multiple myeloma is expected to be initiated
by the end of 2024 as part of the DREAMM programme.
In 2024, belantamab mafodotin
combinations have been filed in the US,
European Union[1],
Japan[2], United
Kingdom, Canada and Switzerland for the treatment of relapsed or
refractory multiple myeloma based on the results of the DREAMM-7
and DREAMM-8 trials. In
China[3], the National Medical Products Administration has granted
Breakthrough Therapy Designation for belantamab mafodotin in
combination with BorDex, as well as priority review for the
regulatory application based on the results of DREAMM-7.
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[4] 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 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] Research into new therapies is
needed as multiple myeloma commonly becomes refractory to available
treatments.[8]
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, Israel and Singapore. 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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