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 March 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 . . . . . . . .
Issued: 07 March 2024, London UK
GSK announces positive results from
DREAMM-8 phase III trial for Blenrep versus standard of care combination in
relapsed/refractory multiple myeloma
●
Trial
unblinded early at an interim analysis based on Independent Data
Monitoring Committee recommendation
●
Blenrep (belantamab
mafodotin) plus PomDex showed statistically significant and
clinically meaningful progression-free survival compared to
bortezomib plus PomDex
●
Consistent efficacy results observed
for Blenrep combinations in two phase III head-to-head
trials
GSK plc (LSE/NYSE: GSK) today announced positive headline results
from an interim analysis of the DREAMM-8 phase III head-to-head
trial evaluating Blenrep (belantamab mafodotin), in combination with
pomalidomide plus dexamethasone (PomDex), versus a standard of
care, bortezomib plus PomDex, as a second line and later treatment
for relapsed or refractory multiple myeloma. The trial met its
primary endpoint of progression-free survival (PFS) at a
pre-specified interim analysis and was unblinded early based on the
recommendation by an Independent Data Monitoring Committee
(IDMC).
The belantamab mafodotin combination significantly extended the
time to disease progression or death versus the standard of care
combination. A positive overall survival (OS) trend favouring
the Blenrep combination
was also observed at the time of this analysis. The trial continues
to follow up for OS. The
safety and tolerability of the belantamab mafodotin regimen were
broadly consistent with the known safety profile of the individual
agents.
Hesham Abdullah, Senior Vice President, Global Head Oncology,
R&D, GSK, said: "The
results seen in both DREAMM-7 and DREAMM-8 provide strong clinical
evidence of the robust efficacy shown with belantamab mafodotin in
use with standard of care combinations. We now look forward to
discussing these data with regulators. If approved, we
believe these combinations have the potential to redefine the
treatment of relapsed or refractory multiple myeloma and advance
the standard of care. This is exciting news for patients given the
high unmet medical need for both efficacious and easily
administered therapies with differing mechanisms of
action."
DREAMM-8 is the second phase III head-to-head belantamab mafodotin
combination trial in second line and later treatment for multiple
myeloma to report positive results. Positive findings from
DREAMM-7, a phase III head-to-head trial evaluating belantamab
mafodotin in combination with bortezomib and dexamethasone (BorDex)
versus daratumumab plus BorDex in the same treatment setting,
were presented1 at
the American Society of Clinical Oncology (ASCO) Plenary Series on
6 February 2024. Detailed
findings from DREAMM-8 will be presented at a future medical
congress and shared with regulatory
authorities.
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.
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. Secondary endpoints include OS,
overall response rate, duration of response, minimal residual
disease negativity as assessed by next-generation sequencing,
safety, and patient-reported and quality of life
outcomes.
About multiple myeloma
Multiple myeloma is the third most common blood cancer globally and
is generally considered treatable but not
curable.2,3 There
are approximately 176,000 new cases of multiple myeloma diagnosed
globally each year.4 Research
into new therapies is needed as multiple myeloma commonly becomes
refractory to available treatments.5
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 Characteristics6 for
a full list of adverse events and the complete important safety
information in the United Kingdom.
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.
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)
|
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
2023.
This announcement contains inside information. The person
responsible for arranging the release of this announcement on
behalf of GSK is Victoria Whyte, Company Secretary.
Registered in England & Wales:
No.
3888792
Registered Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
References
1 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/.
2 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.
3 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.
4 Multiple
Myeloma: Statistics. Cancer.net. Published February 2022.
https://www.cancer.net/cancer-types/multiple-myeloma/statistics#:~:text=This%20year%2C%20an%20estimated%2034%2C470,with%20multiple%20myeloma%20in%202020.
Accessed 19 October 2023.
5 Nooka AK,
Kastritis E, Dimopoulos MA. Treatment options for relapsed and
refractory multiple myeloma. Blood.
2015;125(20).
6 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: March
07, 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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