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 2024
Commission
File Number 001-15170
GSK plc
(Translation
of registrant's name into English)
980 Great West Road, Brentford, Middlesex, TW8 9GS
(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 . . . . . . . .
GSK plc (the
'Company')
Transaction notification
Issued: 19 July 2024, London UK
Blenrep (belantamab
mafodotin) combinations in multiple myeloma application accepted
for review by the European Medicines Agency
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Regulatory
submission supported by phase III head-to-head DREAMM-7 and
DREAMM-8 trials
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Trials
showed significant progression-free survival benefit and positive
overall survival trends for Blenrep combinations versus
standard of care
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If
approved, Blenrep plus BorDex or PomDex
could redefine the relapsed/refractory multiple myeloma treatment
landscape
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GSK plc (LSE/NYSE: GSK) today announced that the European Medicines
Agency (EMA) has accepted the marketing authorisation application
(MAA) for Blenrep (belantamab mafodotin) in combination with
bortezomib plus dexamethasone (BorDex) or pomalidomide plus
dexamethasone (PomDex) as a treatment for relapsed or refractory
multiple myeloma. The EMAÕs Committee for Medicinal Products
for Human Use (CHMP) will begin the formal review process to make a
recommendation to the European Commission regarding this potential
authorisation.
Hesham Abdullah, Senior Vice President, Global Head Oncology,
R&D, GSK, said:
ÒTodayÕs milestone reinforces the potential
for Blenrep to redefine outcomes for patients with
multiple myeloma at or after first relapse. We are working to
bring Blenrep to patients as quickly as possible given the
high unmet need and the clinically robust effects of
the Blenrep combinations in the DREAMM-7 and DREAMM-8
phase III head-to-head trials.Ó
The application is based on interim results from the DREAMM-7 and
DREAMM-8 phase III trials, which both met their primary endpoints,
showing statistically significant and clinically meaningful
improvements in progression-free survival (PFS) for the belantamab
mafodotin combinations compared to standard of care combinations in
relapsed or refractory multiple myeloma. The DREAMM-7 trial is
evaluating belantamab mafodotin combined with BorDex versus
daratumumab plus BorDex, while the DREAMM-8 trial is evaluating
belantamab mafodotin in combination with PomDex versus bortezomib
plus PomDex.
A positive overall survival (OS) trend was observed in both trials
but was not statistically significant at the time of interim
analysis. Follow-up for OS continues. Results also showed
clinically meaningful improvements across all other secondary
efficacy endpoints, including deeper and more durable responses
compared to the respective standard of care combinations. The
safety and tolerability profiles of the belantamab mafodotin
combinations in DREAMM-7 and DREAMM-8 trials were broadly
consistent with the known profiles of the individual
agents.
About multiple myeloma
Multiple myeloma is the third most common blood cancer globally and
is generally considered treatable but not
curable.[1],[2] There
are approximately more than 180,000 new cases of multiple myeloma
diagnosed globally each year, including approximately 50,000 new
cases in Europe.[3],[4] Research
into new therapies is needed as multiple myeloma commonly becomes
refractory to available treatments.[5]
About DREAMM-7
The DREAMM-7 phase III clinical trial is a multicentre, open-label,
randomised trial evaluating the efficacy and safety of belantamab
mafodotin in combination with BorDex compared to a combination of
daratumumab and BorDex 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.
A total of 494 participants were randomised at a 1:1 ratio to
receive either belantamab mafodotin in combination with BorDex or a
combination of daratumumab and BorDex. Belantamab mafodotin was
scheduled to be dosed at 2.5mg/kg intravenously every three
weeks.
The primary endpoint is PFS as per an independent review committee.
The key secondary endpoints include 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 from DREAMM-7 were first presented[6] at
the American Society of Clinical Oncology (ASCO) Plenary Series in
February 2024, shared in an encore presentation at the 2024 ASCO
Annual Meeting, and published in the New England
Journal of Medicine.
About DREAMM-8
The DREAMM-8 phase III clinical trial is a multicentre, open-label,
randomised trial evaluating the efficacy and safety of belantamab
mafodotin in combination with PomDex compared to a combination of
bortezomib and PomDex 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. 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, 75% were refractory
to lenalidomide, 25% had prior daratumumab exposure and of those
most were daratumumab refractory.
A total of 302 participants were randomised at a 1:1 ratio to
receive either belantamab mafodotin plus PomDex, or bortezomib plus
PomDex.
The primary endpoint is PFS as per an independent review committee.
The key secondary endpoints include 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 from DREAMM-8 were first presented[7] at
the 2024 ASCO Annual Meeting and published in
the New England
Journal of Medicine.
About Blenrep
Blenrep is an
antibody-drug conjugate comprising a humanised B-cell maturation
antigen 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.
Refer to the Blenrep UK Summary of Product
Characteristics[8] for
a full list of adverse events and the complete important safety
information in the United Kingdom.
GSK in oncology
GSK is committed to maximising patient survival through
transformational medicines, with a current focus on breakthroughs
in immuno-oncology and tumour-cell targeting therapies, and
development in haematologic malignancies, gynaecologic cancers, and
other solid tumours.
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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GSK enquiries
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Media:
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Tim
Foley
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+44 (0)
20 8047 5502
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(London)
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Madison
Goring
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+44 (0)
20 8047 5502
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(London)
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Kathleen
Quinn
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+1 202
603 5003
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(Washington
DC)
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Lyndsay
Meyer
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+1 202
302 4595
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(Washington
DC)
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Investor
Relations:
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Nick
Stone
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+44 (0)
7717 618834
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(London)
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James
Dodwell
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+44 (0)
20 8047 2406
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(London)
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Mick
Readey
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+44 (0)
7990 339653
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(London)
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Josh
Williams
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+44 (0)
7385 415719
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(London)
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Camilla
Campbell
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+44 (0)
7803 050238
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(London)
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Steph
Mountifield
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+44 (0)
7796 707505
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(London)
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Jeff
McLaughlin
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+1 215
751 7002
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(Philadelphia)
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Frannie
DeFranco
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+1 215
751 4855
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(Philadelphia)
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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 under Item 3.D
ÒRisk factorsÓ in GSKÕs Annual Report on Form 20-F
for 2023, and GSKÕs Q1 Results for 2024.
Registered in England & Wales:
No.
3888792
Registered Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
[1] 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.
[2] Kazandjian D. Multiple myeloma
epidemiology and survival: A unique malignancy. Semin Oncol.
2016;43(6):676Ð681.doi:10.1053/j.seminoncol.2016.11.004.
[3] 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 July 2024.
[4] 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 July 2024.
[5] Nooka
AK, Kastritis E, Dimopoulos MA. Treatment options for relapsed and
refractory multiple myeloma. Blood.
2015;125(20).
[6] 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/
[7] GSK
press release issued 02 June 2024. Blenrep combination reduced the
risk of disease progression or death by nearly 50% versus standard
of care combination in relapsed/refractory multiple myeloma
Available at:
https://www.gsk.com/en-gb/media/press-releases/blenrep-combination-reduced-the-risk-of-disease-progression/
[8] Blenrep UK
Summary of Product Characteristics. Available
at: https://mhraproducts4853.blob.core.windows.net/docs/6f7040d4dd63fafa1f228164fce767517be4e3c6.
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
19, 2024
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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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