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 April 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:
17 April 2025, London UK
Blenrep (belantamab mafodotin)
combinations approved by UK MHRA in relapsed/refractory multiple
myeloma
●
Superior efficacy
shown in two head-to-head phase III trials, including overall
survival in DREAMM-7
●
UK approval first
in the world with submissions under review in 14 markets and
additional approvals expected in 2025
GSK plc
(LSE/NYSE: GSK) today announced the authorisation
of Blenrep by the
Medicines and Healthcare products Regulatory Agency (MHRA). In the
UK, Blenrep is
approved for the treatment of adults with 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. This UK regulatory
authorisation marks the first in the world
for Blenrep in this treatment
setting.
Superior efficacy results from the pivotal DREAMM-7 and DREAMM-8
phase III trials in relapsed or refractory multiple myeloma support
MHRA authorisation 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: "Today's approval of Blenrep combinations in the UK is a transformative
milestone for patients with multiple myeloma, a cancer marked by
remission and relapse. As the only BCMA-targeted ADC
therapy, Blenrep has the potential, supported by robust
phase III data, to extend survival and remission versus standard of
care and redefine treatment at or after first
relapse."
Currently, most patients with multiple myeloma experience relapse,
and in the UK only 55% remain alive five years after
diagnosis.[5] Blenrep is
the only anti-BCMA (B-cell maturation antigen) antibody-drug
conjugate (ADC) 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.
Joseph Mikhael, MD, Chief Medical Officer, International Myeloma
Foundation and Professor, Translational Genomics Research
Institute, City of Hope Cancer Center, said: "As patients with multiple myeloma increasingly
receive combination therapies at diagnosis, treatment options
available in the community setting that use different mechanisms
like Blenrep are crucial to extending remission and
ultimately survival. We are pleased to see this advancement in the
treatment landscape extended across both academic and community
settings where many patients are
treated."
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
nearly tripled median PFS versus the daratumumab-based comparator
(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
(n=243) versus the daratumumab-based comparator (n=251) (HR 0.58;
95% CI: 0.43-0.79; p=0.00023).4 The
three-year OS rate was 74% in the Blenrep combination arm and 60% in the daratumumab
combination arm. In DREAMM-8, at a median
follow-up of 21.8 months, the median PFS was not yet reached with
the Blenrep combination
compared to 12.7 months in the bortezomib
combination.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
Eye-related side effects, a known side effect of treatment
with Blenrep,
were generally resolvable, manageable with extended time between
infusions and dose reductions while maintaining efficacy, and led
to low (≤9%) treatment discontinuations 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 14 countries, including in the US with
a Prescription Drug User Fee Act (PDUFA) date of 23 July
2025,[6] European
Union,[7] Japan (with
priority review),[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.[12] Multiple
myeloma is a significant concern in the UK, which ranks fifth in
incidence rate of all European countries. There are approximately
more than 6,500 new cases of multiple myeloma diagnosed each year
and an expected 5-year prevalence of over 19,400 cases in the
UK.[13],[14] 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.[15],[16]
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 which will be published on the MHRA
Products website within
7 days of approval.
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/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. Results were
first presented at the American Society of Clinical Oncology
(ASCO) Plenary Series in February 2024 and published in
the New England Journal of
Medicine.2
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/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. Results were
first presented at the 2024 ASCO Annual Meeting and published
in the New England Journal of
Medicine.3
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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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.
Registered
in England & Wales:
No.
3888792
Registered
Office:
79 New
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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 Health Service. Cancer Survival in
England, cancers diagnosed 2016 to 2020, followed up to 2021.
Available at:
https://digital.nhs.uk/data-and-information/publications/statistical/cancer-survival-in-england/cancers-diagnosed-2016-to-2020-followed-up-to-2021/survival-by-cancer-group.
[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 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/.
[8] GSK press release issued 17 September 2024.
Blenrep (belantamab mafodotin) combinations in relapsed/refractory
multiple myeloma accepted for regulatory review in Japan. Available
at:
https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-in-relapsedrefractory-multiple-myeloma-accepted-for-regulatory-review-in-japan/.
[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] Global Cancer Observatory. International Agency
for Research on Cancer. World Health Organization. United Kingdom
fact sheet. Available at:
https://gco.iarc.who.int/media/globocan/factsheets/populations/826-united-kingdom-fact-sheet.pdf.
Accessed 5 March 2025.
[15] 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.
[16] 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.
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: April
17, 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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