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: 23 May 2025, London UK
Blenrep (belantamab
mafodotin) combinations receive positive CHMP opinion in
relapsed/refractory multiple myeloma
● Positive opinion supported by superior efficacy
shown in two head-to-head phase III trials, including overall
survival in DREAMM-7
● If
approved, Blenrep combinations
could redefine treatment as early as first relapse where more
effective options are needed[1],[2],[3]
●
Approval decision expected in Q3
2025
GSK plc (LSE/NYSE: GSK) today announced the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency
(EMA) has recommended the approval of Blenrep 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. An approval decision by the
European Commission is expected in the third quarter of
2025.
The CHMP opinion follows the approval of Blenrep combinations by the UK Medicines and
Healthcare products Regulatory Agency (MHRA) in April and Japan's
Ministry of Health, Labour and Welfare earlier this
month.
Superior efficacy results shown by Blenrep combinations
in the pivotal DREAMM-7 and DREAMM-8 phase III trials in relapsed
or refractory multiple myeloma support the CHMP opinion. 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)
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
positive CHMP opinion is an important milestone toward bringing the
benefits of Blenrep combinations
to patients with multiple myeloma in
Europe. Blenrep is
well positioned to address the unmet needs of these patients while
also providing the benefit of in-office administration in both
academic and community treatment settings without
complex pre-administration regimens or
hospitalisation."
There are approximately 50,000 new cases of multiple myeloma
diagnosed each year in Europe, and nearly all patients will
experience relapse from initial treatment.1,[5] Blenrep is
the only anti-BCMA (B-cell maturation antigen) antibody-drug
conjugate (ADC) agent in multiple myeloma, providing patients at or
after first relapse with a differentiated mechanism of
action. Blenrep combinations can be administered to a range
of patient types in any oncology treatment
setting.
DREAMM-7 and DREAMM-8 showed that any eye-related side effects
associated with Blenrep can
be managed and reversed with appropriate dose modifications and
follow-up, allowing patients to maintain benefit and resulting in
low rates of discontinuation (≤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
the Blenrep combination
arm of DREAMM-8.
Blenrep combinations
are currently under review in all major markets globally, including
in the US[6] with
a Prescription Drug User Fee Act (PDUFA) date of 23 July
2025, China[7] (based
on the results of DREAMM-7, with Breakthrough Therapy Designation
for the combination and priority review for the application),
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.[8],[9] There
are approximately more than 180,000 new cases of multiple myeloma
diagnosed globally each year.[10] 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.[11],[12]
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 UK, Blenrep is indicated in adults for the treatment of
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
More information can be found in the Blenrep Summary
of Product Characteristics and Patient Information leaflets
available on the MHRA Products website.[13]
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 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. 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] 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 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/.
[7] 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/.
[8] 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.
[9] 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.
[10] 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.
[11] 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.
[12] 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.
[13] Medicines
& Healthcare products Regulatory Agency website:
https://products.mhra.gov.uk/.
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
23, 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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