UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR
15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the
month of May 2025
Commission
File Number 001-15170
GSK plc
(Translation
of registrant's name into English)
79 New Oxford Street, London, WC1A 1DG
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F . . . .X. . . . Form 40-F . . . . . . . .
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],[2],[3]
●
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] 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] 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] 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 with
a Prescription Drug User Fee Act (PDUFA) date of 23 July
2025,[7] European
Union,[8] China (based
on the results of DREAMM-7, with Breakthrough Therapy Designation
for the combination and priority review for the
application),[9] 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],[11] There
are approximately more than 180,000 new cases of multiple myeloma
diagnosed globally each year, including more than 7,200 in
Japan.[12],[13],[14],[15] 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],[17]
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.[18]
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.
Registered in England & Wales:
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3888792
Registered Office:
79
New Oxford Street
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WC1A
1DG
[1] Nooka
AK, Kastritis E, Dimopoulos MA. Treatment options for relapsed and
refractory multiple myeloma. Blood. 2015;125(20).
doi:10.1182/blood-2014-11-568923.
[2] Hungria
V, Robak P, Hus M et al. Belantamab Mafodotin, Bortezomib, and
Dexamethasone for Multiple Myeloma. N Engl J Med. 2024 Aug
1;391(5):393-407. doi: 10.1056/NEJMoa2405090. Epub 2024 Jun 1.
PMID: 38828933.
[3] Dimopoulos
MA, Beksac M, Pour L, Delimpasi S et al. Belantamab
Mafodotin, Pomalidomide, and Dexamethasone in Multiple Myeloma. N
Engl J Med. 2024 Aug 1;391(5):408-421. doi: 10.1056/NEJMoa2403407.
Epub 2024 Jun 2. PMID: 38828951.
[4] Hungria
V, Robak P, H Marek et al. Belantamab Mafodotin, Bortezomib, and
Dexamethasone Vs Daratumumab, Bortezomib, and Dexamethasone in
Relapsed/Refractory Multiple Myeloma: Overall Survival Analysis and
Updated Efficacy Outcomes of the Phase 3 Dreamm-7 Trial. Presented
at the 66th American Society of Hematology (ASH) Annual Meeting and
Exposition. December 2024.
[5] National
Cancer Registry (Ministry of Health, Labour and Welfare), tabulated
by Cancer Information Service, National Cancer Center, Japan.
Available
here: https://ganjoho.jp/reg_stat/statistics/data/dl/en.html. Accessed
12 September 2024.
[6] GSK
data on file.
[7] GSK
press release issued 25 November 2024. Blenrep combinations
accepted for review by the US FDA for the treatment of
relapsed/refractory multiple myeloma. Available at:
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/.
[8] GSK
press release issued 19 July 2024. Blenrep (belantamab mafodotin)
combinations in multiple myeloma accepted for review by the
European Medicines Agency. Available at:
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/.
[9] GSK
press release issued 9 December 2024. Blenrep (belantamab
mafodotin) combination accepted for priority review in China in
relapsed/refractory multiple myeloma. Available at:
https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combination-accepted-for-priority-review-in-china-in-relapsedrefractory-multiple-myeloma/.
[10] Sung
H, Ferlay J, Siegel R, et al. Global
Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and
Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J
Clin. 2021;71(3):209-249.
doi:10.3322/caac.21660.
[11] Kazandjian
D. Multiple myeloma epidemiology and survival: A unique malignancy.
Semin Oncol. 2016;43(6):676-681.doi:
10.1053/j.seminoncol.2016.11.004.
[12] Global
Cancer Observatory. International Agency for Research on Cancer.
World Health Organization. Multiple Myeloma fact sheet. Available
at:
https://gco.iarc.who.int/media/globocan/factsheets/cancers/35-multiple-myeloma-fact-sheet.pdf.
Accessed 5 March 2025.
[13] Global
Cancer Observatory. International Agency for Research on Cancer.
World Health Organization. Age-Standardized Rate (World) per
100,000, Incidence, Both sexes, in 2022. Available at:
https://gco.iarc.who.int/today/en/dataviz/bars?mode=population&cancers=35&populations=100_112_191_196_203_208_233_246_250_276_300_348_352_372_380_40_428_440_442_470_498_499_528_56_578_616_620_642_643_688_70_703_705_724_752_756_8_804_807_826&types=0&sort_by=value0.
Accessed 5 March 2025.
[14] Ozaki
S, Handa H, Saitoh T, et al. Trends
of survival in patients with multiple myeloma in Japan: a
multicenter retrospective collaborative study of the Japanese
Society of Myeloma. Blood
Cancer J. 2015 Sep 18;5(9):e349.
[15] Handa
H, Ishida T, Ozaki S et al. Treatment
pattern and clinical outcomes in multiple myeloma patients in Japan
using the Medical Data Vision claims database. PLoS One. 2023 Apr
6;18(4):e0283931.
[16] Gajra
A, Zalenski A, Sannareddy A, et al. Barriers
to Chimeric Antigen Receptor T-Cell (CAR-T) Therapies in Clinical
Practice. Pharmaceut
Med. 2022 Jun;36(3):163-171.
[17] Crombie
J, Graff T, Falchi L, et al. Consensus
recommendations on the management of toxicity associated with
CD3~CD20 bispecific antibody therapy. Blood (2024)
143 (16): 1565-1575.
[18] Japan
Pharmaceuticals and Medical Devices Agency website:
https://www.info.pmda.go.jp/psearch/html/menu_tenpu_base.html.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorised.
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GSK plc
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(Registrant)
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Date: May
19, 2025
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By:/s/ VICTORIA
WHYTE
--------------------------
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GSK plc
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