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 November 2024
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: 14 November 2024, London UK
Blenrep shows
overall survival benefit in head-to-head DREAMM-7 phase III trial
for relapsed/refractory multiple myeloma
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Statistically significant and clinically
meaningful reduction in the risk of death seen
with Blenrep (belantamab mafodotin) plus bortezomib and
dexamethasone (BorDex) versus daratumumab plus
BorDex
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Full
data to be presented at 2024 American Society of Hematology Annual
Meeting in December
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Data
to be shared with health authorities to support regulatory
filings
GSK plc (LSE/NYSE: GSK) today announced positive
headline results from a planned interim analysis of the DREAMM-7
head-to-head phase III trial evaluating Blenrep (belantamab
mafodotin) in combination with bortezomib plus dexamethasone
(BorDex) as
a second-line or later treatment for relapsed or refractory
multiple myeloma. The trial met the key secondary endpoint of
overall survival (OS), showing that belantamab mafodotin when
combined with BorDex significantly reduced the risk of death versus
standard of care daratumumab plus BorDex.
Hesham Abdullah, Senior Vice President, Global Head Oncology,
R&D, GSK, said: "The
overall survival results from the DREAMM-7 trial underscore the
potential for this Blenrep combination
to extend the lives of patients with relapsed/refractory multiple
myeloma. This is a statistically significant and clinically
meaningful advancement for patients and potentially transformative
for treatment. We look forward to sharing these data with health
authorities and presenting the full results at next month's
American Society of Hematology Annual Meeting."
Results from the interim analysis, including safety data, will be
presented at the upcoming 66th American
Society of Hematology (ASH) Annual Meeting and Exposition on 9
December 2024 at 11:15 a.m. PT.
The DREAMM (DRiving Excellence in Approaches to Multiple Myeloma)
clinical development programme continues to evaluate the potential
of belantamab mafodotin in early lines of treatment and in
combination with novel therapies and standard of care treatments.
In addition to DREAMM-7, this includes the ongoing head-to-head
phase III DREAMM-8 trial evaluating belantamab mafodotin in
combination with pomalidomide and dexamethasone versus bortezomib
in combination with pomalidomide and dexamethasone.
A phase III study in newly diagnosed transplant ineligible multiple
myeloma is expected to be initiated by the end of 2024 as part of
the DREAMM programme.
In 2024, belantamab mafodotin combinations have been filed in the
US, European
Union[1], Japan[2],
United Kingdom, Canada and Switzerland for the treatment of
relapsed or refractory multiple myeloma based on the results of the
DREAMM-7 and DREAMM-8 trials. In China[3],
the National Medical Products Administration has granted
Breakthrough Therapy Designation for belantamab mafodotin in
combination with BorDex, as well as priority review for the
regulatory application based on the results of
DREAMM-7.
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[4] 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 multiple myeloma
Multiple myeloma is the third most common blood cancer globally and
is generally considered treatable but not
curable.[5],[6] There
are approximately more than 180,000 new cases of multiple myeloma
diagnosed globally each year.[7] Research
into new therapies is needed as multiple myeloma commonly becomes
refractory to available treatments.[8]
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.
Blenrep is
approved as monotherapy in Hong Kong, Israel and Singapore. Refer
to the local Summary of Product Characteristics for a full list of
adverse events and complete important safety
information.
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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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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Annabel
Brownrigg-Gleeson
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+44 (0)
7901 101944
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(London)
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James
Dodwell
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+44 (0)
7881 269066
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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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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
"Risk factors" in GSK's Annual Report on Form 20-F for 2023, and
GSK's Q3 Results for 2024.
Registered in England & Wales:
No.
3888792
Registered Office:
79
New Oxford Street
London
WC1A
1DG
[1] 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/.
[2] 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/.
[3] GSK
press release issued 13 September 2024. Blenrep (belantamab
mafodotin) in combination receives Breakthrough Therapy Designation
in China for treatment of relapsed/refractory multiple myeloma.
Available at:
https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-in-combination-receives-breakthrough-therapy-designation-in-china-for-treatment-of-relapsedrefractory-multiple-myeloma/.
[4] 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/.
[5] 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.
[6] 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.
[7] 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 12 November 2024.
[8] Nooka
AK, Kastritis E, Dimopoulos MA. Treatment
options for relapsed and refractory multiple myeloma. Blood.
2015;125(20).
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: November
14, 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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