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 2023
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 . . . . . . . .
Issued: 27 November 2023, London UK
GSK announces positive results from
DREAMM-7 head-to-head phase III trial for Blenrep in relapsed/refractory multiple
myeloma
●
Blenrep (belantamab
mafodotin) plus BorDex showed statistically significant
progression-free survival (PFS) benefit versus daratumumab plus
BorDex
●
Trial
unblinded early based on Independent Data Monitoring Committee
(IDMC) recommendation
GSK plc (LSE/NYSE: GSK) today announced positive headline results
from a planned interim efficacy analysis of the DREAMM-7
head-to-head phase III trial evaluating belantamab mafodotin as a
second-line treatment for relapsed or refractory multiple myeloma.
The trial met its primary endpoint of progression-free survival
(PFS) and showed that belantamab mafodotin when combined with
bortezomib plus dexamethasone (BorDex) significantly extended the
time to disease progression or death versus daratumumab plus
BorDex, an existing standard of care for relapsed/refractory
multiple myeloma. A
strong and clinically meaningful overall survival (OS) trend with
nominal p value < 0.0005 was also observed at the time of this
analysis, and the trial continues to follow up for
OS.
Hesham Abdullah, Senior Vice President, Global Head Oncology,
R&D, GSK, said: "Patients
with multiple myeloma need treatment options after first relapse
that are efficacious, readily accessible and have novel mechanisms
of action. We are particularly encouraged by the potential for
belantamab mafodotin when combined with BorDex to address high
unmet need in relapsed/refractory multiple myeloma, given the
head-to-head comparison with the daratumumab-based standard of care
regimen."
The safety and tolerability of the belantamab mafodotin regimen was
consistent with the known safety profile of the individual
agents.
Results from the interim analysis will be presented at an upcoming
scientific meeting and shared with health
authorities.
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.
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. DREAMM-8 data are expected in the
second half of 2024.
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 bortezomib
and dexamethasone (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. Participants had
been previously
treated with at least one prior line of multiple myeloma
therapy with documented disease progression during or after their
most recent therapy. Belantamab mafodotin was dosed at 2.5mg/kg
intravenously every three weeks.
The primary endpoint is progression-free survival as per an
independent review committee. The
key secondary endpoints include overall
survival, duration of response, and minimal
residual disease negativity rate as assessed by next-generation
sequencing.
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 176,000 new cases of multiple myeloma diagnosed
globally each year.3 Research
into new therapies is needed as multiple myeloma commonly becomes
refractory to available treatments.4
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 EMA
Reference Information
(https://www.ema.europa.eu/en/medicines/human/EPAR/blenrep) for a
full list of adverse events and the complete important safety
information in the EU.
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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Dan
Smith
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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
'Risk factors" in the company's Annual Report on Form 20-F for
2022, and Q3 Results for 2023.
Registered in England & Wales:
No.
3888792
Registered Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
References
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):676-681.
doi:10.1053/j.seminoncol.2016.11.004.
3 Multiple Myeloma. World Health Organization International Agency
for Research on Cancer.
https://gco.iarc.fr/today/data/factsheets/cancers/35-Multiple-myeloma-fact-sheet.pdf.
4 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
27, 2023
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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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