Issued: 17 September 2024, London
UK
Blenrep
(belantamab
mafodotin) combinations in relapsed/refractory multiple myeloma
accepted for regulatory review in Japan
· Regulatory submission supported by phase III head-to-head
DREAMM-7 and DREAMM-8 trials
· If approved, Blenrep
plus BorDex or PomDex could redefine relapsed/refractory multiple
myeloma treatment landscape
· More than 7,200 new cases of multiple myeloma are diagnosed in
Japan each year[1]
GSK plc (LSE/NYSE: GSK) today
announced that Japan's Ministry of Health, Labour and Welfare
(MHLW) has accepted for review a new drug application (NDA) 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. MHLW also has granted
orphan drug designation for Blenrep, which reflects the high unmet
medical need and ensures priority NDA review in multiple
myeloma.
This is the third major regulatory
filing acceptance for belantamab mafodotin combinations in the
treatment of relapsed/refractory multiple myeloma, following
marketing authorisation application acceptance[2] by the European
Medicines Agency (EMA) in July 2024 and by the Medicines and
Healthcare products Regulatory Agency (MHRA) in the UK earlier this
month.
Hesham Abdullah, Senior Vice President, Global Head Oncology,
R&D, GSK, said: "Blenrep combinations show potential
based on the results of the DREAMM-7 and DREAMM-8 trials to
redefine the treatment of relapsed/refractory multiple myeloma. We
are committed to working with health authorities worldwide to
advance Blenrep along
regulatory pathways so we can bring these additional treatment
options to patients as quickly as possible."
Multiple myeloma presents a growing
health concern in Japan, where the number of patients diagnosed
with multiple myeloma per year has increased continuously over the
last five decades.[3],[4] This underscores the urgent
need for more treatment options for patients in Japan, particularly
those with progressing disease that has become resistant to the
current standard of care.
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. 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. 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.
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 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,[5] There are
approximately more than 180,000 new cases of multiple myeloma
diagnosed globally each year.[6] More than 7,200
new cases of multiple myeloma are diagnosed in Japan each
year.1 Research into new therapies is needed as multiple
myeloma commonly becomes refractory to available
treatments.[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,
including Japanese patients, 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[8]
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.
A Japan expansion cohort is set to
further evaluate the DREAMM-7 protocol in Japanese patients.
Results for Japanese participants will be presented at a future
scientific meeting.
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,
including Japanese patients, 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[9]
at the 2024 ASCO Annual Meeting and published in
the New England Journal of
Medicine.
A Japan expansion cohort is set to
further evaluate the DREAMM-8 protocol in Japanese patients.
Results for Japanese participants will be presented at a future
scientific meeting.
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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