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 July 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: 24 July 2025, London UK
Blenrep (belantamab
mafodotin) combinations approved in EU for treatment of
relapsed/refractory multiple myeloma
●
Two
head-to-head phase III trials demonstrated superior efficacy,
including overall survival versus a daratumumab-based triplet in
DREAMM-7
●
Blenrep,
a first-in-class anti-BCMA ADC,
could transform treatment as early as first relapse where
additional effective and accessible options are
needed[1],[2],[3]
●
Sixth
regulatory approval for Blenrep combinations
with applications under review in all major
markets
GSK plc (LSE/NYSE: GSK) today announced the approval
of Blenrep in the European Union (EU) for the treatment
of adults with relapsed or refractory multiple myeloma in
combination with bortezomib plus dexamethasone (BVd) in patients
who have received at least one prior therapy, and in combination
with pomalidomide plus dexamethasone (BPd) in patients who have
received at least one prior therapy including
lenalidomide.
The approval is based on superior efficacy results demonstrated
by Blenrep combinations
in the pivotal DREAMM-7 and DREAMM-8 phase III trials in relapsed
or refractory multiple myeloma. These include statistically
significant and clinically meaningful progression-free
survival (PFS) for Blenrep combinations
versus triplet standard of care combinations in both trials and
overall survival (OS) versus a daratumumab-based triplet 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: "Today's
approval of Blenrep combinations
is a redefining moment for patients with relapsed or refractory
multiple myeloma in the EU. Blenrep has
the potential to extend remission and survival, with superior
efficacy versus standards of care in our DREAMM clinical trial
programme and the option to administer in both academic and
community-based settings."
More than 50,000 cases of multiple myeloma are diagnosed in Europe
each year, accounting for more than a quarter of global
incidence.[5] Blenrep is
the only anti-BCMA (B-cell maturation antigen) antibody-drug
conjugate (ADC) approved in multiple myeloma, providing patients
with a differentiated mechanism of action to potentially help slow
disease progression and extend survival.1 Blenrep combinations
can be administered to a range of patient types across oncology
treatment settings, enabling broad accessibility of an anti-BCMA
therapy.
María-Victoria Mateos, MD, PhD, Head of Myeloma and Clinical
Trials Unit, Haematology Department and Professor of Medicine at
the University of Salamanca, Spain, and DREAMM-7 principal
investigator, said: "With
the approval of Blenrep combinations
in the EU, we now have additional tools in our efforts to keep
patients in remission longer, maintain quality of life and extend
survival. The robust efficacy supported by the DREAMM-7 and
DREAMM-8 trials, together with manageable outpatient administration
in academic and community settings,
positions Blenrep combinations
as a fundamentally differentiated treatment approach for multiple
myeloma patients starting from first relapse."
Both DREAMM-7 and DREAMM-8 showed statistically significant and
clinically meaningful PFS improvements for
the Blenrep combinations
compared to standard of care triplet combinations in the second
line or later treatment of multiple myeloma.2,3 In
DREAMM-7, the Blenrep combination
(n=243) nearly tripled median PFS versus the daratumumab-based
comparator (n=251) (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).2 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
the Blenrep combination
versus the daratumumab-based comparator (HR: 0.58; 95% CI:
0.43-0.79; p=0.00023). The median OS was not reached in either arm
of the study. The three-year OS rate was 74% in
the Blenrep combination
arm and 60% in the daratumumab combination arm.4 In
DREAMM-8, 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
the Blenrep combination
compared to 12.7 months in the bortezomib combination (95% CI:
9.1-18.5) at the time of primary analysis.3
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
DREAMM-7 and DREAMM-8 showed that eye-related side effects
associated with Blenrep can
be managed and reversed with appropriate dose modifications and
follow-up. This allowed patients to maintain benefit and resulted
in low rates of discontinuation due to eye-related side effects
(≤9%) in both trials.2,3 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
DREAMM-8.2,3
Blenrep combinations
are also approved in relapsed or refractory multiple myeloma in
the UK[6] and Japan[7] as
well as other markets, including Canada and Switzerland (based on
the results of DREAMM-8). Applications are currently under review
in all major markets globally, including the US[8] and China[9] (based
on the results of DREAMM-7, with Breakthrough Therapy Designation
for the combination and priority review for the
application).
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.5 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.[12],[13]
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.
Indication
In the EU, Blenrep is indicated in adults for the treatment of
relapsed or refractory multiple myeloma:
●
in
combination with bortezomib and dexamethasone in patients who have
received at least one prior therapy; and
●
in
combination with pomalidomide and dexamethasone in patients who
have received at least one prior therapy including
lenalidomide.
IMPORTANT SAFETY INFORMATION
FOR BLENREP
Refer to the Blenrep EMA
Reference Information[14] which
will soon be available for a full list of adverse events and the
complete important safety information in the
EU.
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 in
combination for the first eight cycles and then continued as a
single agent. 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.
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 then 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.
Results were first presented at the 2024 ASCO Annual Meeting
and published in the New England
Journal of Medicine.3 Updated
PFS results were presented at the European Hematology Association
(EHA) Congress in June 2025.[15]
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 women's 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 "Risk
Factors" section in GSK's Annual Report on Form 20-F for 2024, and
GSK's Q1 Results for 2025.
Registered in England & Wales:
No.
3888792
Registered Office:
79
New Oxford Street
London
WC1A
1DG
[1] Nooka
AK, Kastritis E, Dimopoulos MA, et al. Treatment options for
relapsed and refractory multiple myeloma. Blood. 2015 May
14;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] 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.
[6] GSK
press release issued 17 April 2025. Blenrep (belantamab mafodotin)
combinations approved by UK MHRA in relapsed/refractory multiple
myeloma. Available at
https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-approved-by-uk-mhra-in-relapsedrefractory-multiple-myeloma/.
[7] GSK
press release issued 19 May 2025. Blenrep (belantamab mafodotin)
combinations approved in Japan for treatment of relapsed/refractory
multiple myeloma. Available at
https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-approved-in-japan/.
[8] 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/.
[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] 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. doi:
10.1007/s40290-022-00428-w. Epub 2022 Jun 7.
[13] 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. doi:
10.1182/blood.2023022432.
[14] European
Medicines Agency. Available at:
https://www.ema.europa.eu/en/medicines/human/EPAR/blenrep-0.
Accessed 8 July 2025.
[15] Dimopoulos
MA, Beksac M, Pour L, et al. Updated results from phase 3 DREAMM-8
study of Belantamab Mafodotin, Pomalidomide and Dexamethasone
versus Pomalidomide plus Bortezomib and Dexamethasone in
relapsed/refractory multiple myeloma. HemaSphere | 2025;9(S1) 846
EHA 2025 Congress.
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: July
24, 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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