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 October 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 October 2025, London UK
Blenrep approved
by US FDA for use in treatment of relapsed/refractory multiple
myeloma
●
Significant
unmet need for patients requires new and novel
treatments[1]
●
DREAMM-7
showed a
51% reduction in the risk of death and tripled median
progression-free survival in 3L+ indicated
population versus
a daratumumab-based triplet
[2]
●
Blenrep is
the only anti-BCMA accessible in the community setting where 70% of
patients receive care, and with a new streamlined REMS
programme[3]
●
Robust
clinical development is ongoing to advance Blenrep in
earlier lines of treatment, including newly diagnosed
patients[4]
GSK plc (LSE/NYSE: GSK) today announced the US Food and Drug
Administration (FDA) has approved Blenrep (belantamab mafodotin-blmf) in combination
with bortezomib and dexamethasone (BVd) for the treatment of adult
patients with relapsed or refractory multiple myeloma who have
received at least two prior lines of therapy, including a
proteasome inhibitor (PI) and an immunomodulatory (IMID)
agent.
The Blenrep approval is supported by data from the
pivotal DREAMM-7 phase III trial. In patients who had two or more
prior lines of therapy (3L+), including a PI and an
IMID, Blenrep in combination demonstrated a clinically
meaningful 51% reduction in the risk of death [HR 0.49, 95%
confidence interval (CI): 0.32-0.76] and a tripled median
progression-free survival (PFS) of 31.3 months [95% CI: 23.5-NR)]
versus 10.4 months [95% CI: 7.0-13.4] for a daratumumab-based
triplet (DVd) [HR 0.31, 95% CI: 0.21-0.47]. The safety and
tolerability profiles of the Blenrep combination were broadly consistent with the
known profiles of the individual agents.2
Tony Wood, Chief Scientific Officer, GSK, said: "Today's
FDA approval of Blenrep is
another significant milestone, providing potential for superior
efficacy, including overall survival, to US patients. There is an
urgent need for new and novel therapies, as nearly all patients
with multiple myeloma experience relapse and re-treating with the
same mechanism of action often leads to suboptimal outcomes. As the
only anti-BCMA agent that can be administered across healthcare
settings, including in community centres where 70% of patients
receive care, Blenrep fulfils
a major patient need. We believe Blenrep can
redefine treatment for patients with multiple myeloma in all parts
of the world, and we are accelerating its development in earlier
lines of therapy to support its use across all stages of this
difficult-to-treat cancer."
Working closely with the FDA, Blenrep is available through a new, streamlined Risk
Evaluation and Mitigation Strategy (REMS). The new REMS supports
appropriate use and patient safety while reducing administrative
burden through simplified patient forms, removal of duplicative
checklists and efficient communication between HCPs and either
optometrists or ophthalmologists monitoring eye care. GSK will also
offer Together with GSK, an optional patient support programme
available to all US patients prescribed Blenrep.
Data from the DREAMM (DRiving Excellence in Approaches to Multiple
Myeloma) clinical trial programme will be submitted to the National
Comprehensive Cancer Network (NCCN) guidelines this year. Recent
results from the DREAMM studies, alongside emerging real-world
evidence, provide a growing body of data
for Blenrep.[5],[6]
Sagar Lonial, MD, Chief Medical Officer, Winship Cancer Institute
of Emory University in Atlanta, Georgia, Chair of Emory Department
of Hematology and Medical Oncology, said: "With
the approval of Blenrep,
we now have a community-accessible BCMA-targeting agent with the
potential to improve outcomes for patients following two or more
prior lines of treatment, where options are limited. This approval
marks an important advance in the US relapsed/refractory treatment
landscape."
Michael Andreini, President and Chief Executive Officer of the
Multiple Myeloma Research Foundation and the Multiple Myeloma
Research Consortium, said: "The
reality for most patients with multiple myeloma is a relentless
cycle of remission and relapse, as their disease becomes refractory
to treatments. Patients urgently need more effective treatment
options that can offer more quality time with their loved ones. We
see the potential for Blenrep in combination to help patients achieve
this."
GSK is advancing the DREAMM clinical programme to
demonstrate Blenrep's
potential benefit in earlier lines of treatment. Follow-up
continues for overall survival (OS) in both DREAMM-7 and DREAMM-8
with data expected in early 2028, including in patients who have
received only one prior line of therapy. DREAMM-10, a phase III
trial in newly diagnosed transplant-ineligible patients, which
represent over 70% of patients starting therapy, was initiated in
Q4-2024.4 Interim
efficacy and safety data for Blenrep as
a first line treatment are expected in early 2028 with enrolment
expanded to US sites to increase US patient representation in the
study population. GSK continues to work with the FDA for US
patients.
Approvals outside of the US
Blenrep combinations
are approved in 2L+ relapsed or refractory multiple myeloma in
the European
Union[7], UK[8], Japan[9],
Canada, Switzerland and Brazil. Applications are currently under
review in other markets globally, including China[10] where
the application is based on the results of DREAMM-7 and has been
granted Breakthrough Therapy Designation and Priority
Review.
About multiple myeloma
Multiple myeloma is the third most common blood cancer globally and
is generally considered treatable but not
curable.[11],[12] There
are approximately 180,000 new cases of multiple myeloma diagnosed
globally each year.[13] Research
into new therapies is needed as multiple myeloma commonly becomes
refractory to available treatments.[14] Many
patients with multiple myeloma, including approximately 70% in the
US, 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.3,[15],[16]
About Blenrep
Blenrep is a monoclonal ADC
(antibody-drug conjugate) comprising a humanised
BCMA (B-cell
maturation antigen) 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 US, Blenrep is indicated in combination with bortezomib
and dexamethasone (BVd) for the treatment of adult patients with
relapsed or refractory multiple myeloma who have received at least
two prior lines of therapy, including a proteasome inhibitor and an
immunomodulatory agent.
Please see accompanying US
Prescribing Information which will soon be
available here[17].
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[18] 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[19] were
presented at the American Society of Hematology (ASH) Annual
Meeting in December 2024.
About DREAMM-10
DREAMM-10 is a multicentre, open-label, randomised phase III
clinical trial in newly diagnosed transplant ineligible patients
with multiple myeloma, evaluating belantamab mafodotin plus
lenalidomide and dexamethasone (BRd) versus daratumumab plus
lenalidomide and dexamethasone (DRd).4
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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Investor
Relations:
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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 Q2 Results for 2025.
Registered in England & Wales:
No.
3888792
Registered Office:
79
New Oxford Street
London
WC1A
1DG
[1] Bruno
A, et al. Recent real-world treatment patterns and outcomes in US
patients with relapsed/refractory multiple myeloma. Expert Review
of Hematology. 2020; Volume 13, Issue 9:1017-1025
https://www.tandfonline.com/doi/full/10.1080/17474086.2020.1800451.
[2] Blenrep US
Prescribing Information.
[3] Komodo
claims data. Accessed 25 September 2025.
[4] ClinicalTrials.gov.
National Library of Medicine (US). Identifier NCT06679101, A Study
of Belantamab Mafodotin Administered in Combination With
Lenalidomide and Dexamethasone (BRd) Versus Daratumumab,
Lenalidomide, and Dexamethasone (DRd) in Participants With Newly
Diagnosed Multiple Myeloma (NDMM) Who Are Ineligible for Autologous
Stem Cell Transplantation (TI-NDMM) (DREAMM-10). Available
at:
https://clinicaltrials.gov/study/NCT06679101.
[5] 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.
[6] 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.
[7] GSK
press release issued 24 July 2025. Blenrep (belantamab mafodotin)
combinations approved in EU for treatment of relapsed/refractory
multiple myeloma. Available at:
https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-approved-in-eu-for-treatment-of-relapsedrefractory-multiple-myeloma/.
[8] 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/.
[9] 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/.
[10] 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/.
[11] 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.
[12] 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.
[13] 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.
[14] 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.
[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.
[17] US
Prescribing Information. To be available at:
https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Blenrep/pdf/BLENREP-PI-MG.PDF.
[18] GSK
press release issued 05 February 2024. DREAMM-7 phase III trial
shows Blenrep combination
nearly tripled median progression-free survival versus standard of
care combination in patients with relapsed/refractory multiple
myeloma. Available at:
https://www.gsk.com/en-gb/media/press-releases/dreamm-7-phase-iii-trial-shows-pfs-improvement-and-strong-os-trend-for-blenrep-combo-versus-soc-combo-in-multiple-myeloma/.
[19] GSK
press release issued 09 December 2024. Blenrep shows significant
overall survival benefit, reducing the risk of death by 42% in
multiple myeloma at or after first relapse. Available at:
https://www.gsk.com/en-gb/media/press-releases/blenrep-shows-significant-overall-survival-benefit-reducing-the-risk-of-death-by-42-in-multiple-myeloma-at-or-after-first-relapse/.
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: October
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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