REG - GSK PLC - Blenrep for 2L+ multiple myeloma approved in Japan

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RNS Number : 1832J  GSK PLC  19 May 2025

Issued: 19 May 2025, London UK

 

 

Blenrep (belantamab mafodotin) combinations approved in Japan for treatment of
relapsed/refractory multiple myeloma

·   Superior efficacy shown in two head-to-head phase III trials, including
overall survival in DREAMM-7

·   Blenrep combinations could redefine treatment as early as first relapse
where more effective options are needed 1  (#_edn1) (, 2  (#_edn2) , 3 
(#_edn3) )

·   Second major approval for Blenrep combinations, with more expected in
2025

 

GSK plc (LSE/NYSE: GSK) today announced the approval of Blenrep combinations
by Japanfs Ministry of Health, Labour and Welfare (MHLW) for the treatment of
adults with relapsed or refractory multiple myeloma. The approval is based on
positive results from the DREAMM-7 and DREAMM-8 phase III trials evaluating
Blenrep in combination with bortezomib plus dexamethasone (BVd) and in
combination with pomalidomide plus dexamethasone (BPd), respectively, in
patients with multiple myeloma who have received at least one prior therapy.
The approval follows an orphan drug designation for Blenrep in Japan, which
was granted based on its ability to address high unmet need for patients with
multiple myeloma.

 

Superior efficacy results from the pivotal DREAMM-7 and DREAMM-8 phase III
trials in relapsed or refractory multiple myeloma support MHLW approval of
Blenrep combinations. These include statistically significant and clinically
meaningful progression-free survival (PFS) results for Blenrep combinations
versus standards of care in both trials and overall survival (OS) in
DREAMM-7.(2)(,)(3)(, 4  (#_edn4) ) The safety and tolerability profiles of the
Blenrep combinations were broadly consistent with the known profiles of the
individual agents.(2)(,)(3)

 

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK,
said: gTodayfs approval brings the benefits of Blenrep combinations to
patients with relapsed or refractory multiple myeloma in Japan. Patients need
additional treatment options at or after first relapse that can extend
remission and survival versus standard of care. Blenrep combinations have the
potential to redefine treatment outcomes based on superior efficacy shown in
two phase III trials, with the added advantage of in-office administration in
both academic and community treatment settings.h

 

Most patients with multiple myeloma experience relapse, and in Japan only
about 43% remain alive five years after diagnosis. 5  (#_edn5) Blenrep is the
only anti-BCMA (B-cell maturation antigen) antibody-drug conjugate (ADC)
approved in multiple myeloma, providing patients at or after relapse with a
differentiated mechanism of action. Blenrep combinations can be administered
to a range of patient types in any oncology treatment setting without complex
pre-administration regimens or hospitalisation.

 

In the DREAMM-7 and DREAMM-8 clinical trials, Blenrep combinations
consistently benefited a broad range of patients, including those with poor
prognostic features or outcomes, such as high-risk cytogenetics or those
refractory to lenalidomide. Both trials also showed clinically meaningful
improvements across all other secondary efficacy endpoints, including deeper
and more durable responses versus the respective comparators.(2)(,)(3)

 

Eye-related side effects associated with Blenrep were successfully managed by
extending time between infusions and through dose reductions, allowing
patients to maintain benefit and resulting in low rates of discontinuation
(≤9%) in both trials.(2)(,)(3) Eye exam findings and changes in visual
clarity (known as visual acuity) resolved in 83% of occurrences; with the
trials ongoing, the remaining occurrences were in patients with follow-up
ongoing or lost to follow-up. There have been no confirmed cases of permanent
bilateral vision loss (i.e., no permanent bilateral eye exam findings of
20/200 or worse) based on current Blenrep clinical trial data and previous
monotherapy post-marketing use. 6  (#_edn6) The most commonly reported
non-ocular adverse events (>30% of participants) in the Blenrep combination
arm were thrombocytopenia (87%) and diarrhoea (32%) in DREAMM-7, and
neutropenia (63%), thrombocytopenia (55%) and COVID-19 (37%) in the Blenrep
combination arm of DREAMM-8.

 

This is the second major regulatory approval for Blenrep combinations for the
treatment of relapsed or refractory multiple myeloma, following the first
authorisation in the world last month by the UK Medicines and Healthcare
products Regulatory Agency (MHRA).

 

Blenrep combinations are currently under review in all major markets globally,
including in the US
(https://www.gsk.com/en-gb/media/press-releases/blenrep-combinations-accepted-for-review-by-the-us-fda-for-the-treatment-of-relapsedrefractory-multiple-myeloma/)
with a Prescription Drug User Fee Act (PDUFA) date of 23 July 2025, 7 
(#_edn7) European Union
(https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-in-multiple-myeloma-application-accepted-for-review-by-the-european-medicines-agency/)
, 8  (#_edn8) China
(https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combination-accepted-for-priority-review-in-china-in-relapsedrefractory-multiple-myeloma/)
(based on the results of DREAMM-7, with Breakthrough Therapy Designation for
the combination and priority review for the application), 9  (#_edn9) Canada,
and Switzerland (with priority review for DREAMM-8).

 

About multiple myeloma

Multiple myeloma is the third most common blood cancer globally and is
generally considered treatable but not curable. 10  (#_edn10) (, 11  (#_edn11)
) There are approximately more than 180,000 new cases of multiple myeloma
diagnosed globally each year, including more than 7,200 in Japan. 12 
(#_edn12) (, 13  (#_edn13) ,) 14  (#_edn14) (, 15  (#_edn15) ) Research into
new therapies is needed as multiple myeloma commonly becomes refractory to
available treatments.(1) Many patients with multiple myeloma are treated in a
community cancer setting, leaving an urgent need for new, effective therapies
with manageable side effects that can be administered outside of an academic
centre. 16  (#_edn16) (, 17  (#_edn17) )

 

About Blenrep

Blenrep is an ADC comprising a humanised BCMA 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.

 

In April 2025, the UK Medicines and Healthcare products Regulatory Agency
(MHRA) licensed Blenrep combinations for the treatment of relapsed or
refractory multiple myeloma in adult patients who have received at least one
prior therapy.

 

Indication

In Japan, Blenrep is indicated for the treatment of adults with relapsed or
refractory multiple myeloma.

 

IMPORTANT SAFETY INFORMATION FOR BLENREP

Please refer to the updated Product Information (PI) for precautions
concerning indications, dosage and administration, and safety information in
Japan which will shortly be updated at this link: Japan Pharmaceuticals and
Medical Devices Agency
(https://www.info.pmda.go.jp/psearch/html/menu_tenpu_base.html) . 18 
(#_edn18)

 

About DREAMM-7

DREAMM-7 is a multicentre, open-label, randomised phase III clinical trial
evaluating the efficacy and safety of belantamab mafodotin combined with
bortezomib plus dexamethasone (BVd) compared to daratumumab combined with
bortezomib plus dexamethasone (DVd) in patients with relapsed or 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. The trial enrolled 494 participants who were
randomised 1:1 to receive either BVd or DVd. Belantamab mafodotin was
administered at a dose of 2.5mg/kg intravenously every three weeks. The
primary endpoint was PFS as per an independent review committee, with
secondary endpoints including 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.

 

In DREAMM-7, BVd nearly tripled median PFS versus DVd (36.6 months versus 13.4
months, respectively (hazard ratio  HR : 0.41 [95% confidence interval (CI):
0.31-0.53], p-value<0.00001). DREAMM-7 also met the key secondary endpoint
of OS, showing a statistically significant and clinically meaningful 42%
reduction in the risk of death at a median follow-up of 39.4 months favouring
BVd (n=243) versus DVd (n=251) (HR 0.58; 95% CI: 0.43-0.79; p=0.00023). The
three-year OS rate was 74% in the BVd arm and 60% in the DVd arm.

 

PFS results were presented at the American Society of Clinical Oncology (ASCO)
Plenary Series in February 2024 and published in the New England Journal of
Medicine. OS results were presented at the American Society of Hematology
(ASH) Annual Meeting in December 2024.2(,)(4)

 

About DREAMM-8

DREAMM-8 is a multicentre, open-label, randomised phase III clinical trial
evaluating the efficacy and safety of belantamab mafodotin in combination with
pomalidomide plus dexamethasone (BPd) compared to bortezomib and pomalidomide
plus dexamethasone (PVd) in patients with relapsed or 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. The trial
included 302 participants who were randomised 1:1 to receive either BPd or
PVd. 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. Belantamab
mafodotin was administered at a dose of 2.5mg/kg intravenously for the first
cycle and 1.9mg/kg intravenously every four weeks. The primary endpoint was
PFS as per an independent review committee, with key secondary endpoints
including 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.

 

In DREAMM-8, a statistically significant and clinically meaningful improvement
in PFS (HR: 0.52 [95% CI: 0.37-0.73], p-value<0.001) was observed with BPd
(n=155) compared to PVd (n=147). At a median follow-up of 21.8 months, the
median PFS was not yet reached (95% CI: 20.6-not yet reached  NR ) with BPd
compared to 12.7 months (95% CI: 9.1-18.5) for PVd. At the end of one year,
71% (95% CI: 63-78) of patients in the BPd combination group compared to 51%
(95% CI: 42-60) in the PVd combination group were alive and had not
progressed. A benefit for BPd was observed across all pre-specified subgroups
including those with poor prognostic features, such as patients who were
refractory to lenalidomide and patients with high-risk cytogenetics. A
positive OS trend was observed but not statistically significant (HR: 0.77
[95% CI: 0.53-1.14]) at the interim analysis. OS follow-up continues and
further analyses are planned.

 

Results were first presented at the 2024 ASCO Annual Meeting and published in
the New England Journal of Medicine.3

 

GSK in oncology

Our ambition in oncology is to help increase overall quality of life, maximise
survival and change the course of disease, expanding from our current focus on
blood and womenfs cancers into lung and gastrointestinal cancers, as well as
other solid tumours. This includes accelerating priority programmes such as
antibody-drug conjugates targeting B7-H3 and B7-H4, and IDRX-42, a highly
selective KIT tyrosine kinase inhibitor.

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 in
the gRisk Factorsh section in GSKfs Annual Report on Form 20-F for 2024, and
GSKfs Q1 Results for 2025.

 

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