a1192x
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 December 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:
18 December 2023, London UK
Jemperli (dostarlimab)
plus Zejula (niraparib)
combination significantly improved progression-free survival in
primary advanced or recurrent endometrial cancer in RUBY Part 2
Phase III trial
● Dostarlimab plus chemotherapy followed by
dostarlimab plus niraparib improved progression-free survival vs.
chemotherapy alone in both the overall and mismatch repair
proficient/microsatellite stable (MMRp/MSS) patient
populations
● MMRp/MSS primary advanced or recurrent
endometrial cancer has limited treatment options beyond
chemotherapy alone
● Results reinforce development approach of
using Jemperli as a backbone in
immuno-oncology-based combination therapies
GSK plc (LSE/NYSE: GSK) today announced positive headline results from a
planned analysis of Part 2 of the RUBY/ENGOT-EN6/GOG3031/NSGO phase
III trial investigating Jemperli (dostarlimab) plus standard-of-care
chemotherapy (carboplatin and paclitaxel), followed by dostarlimab
plus Zejula (niraparib) as maintenance therapy, in
adult patients with primary advanced or recurrent endometrial
cancer. The trial, which evaluated this combination against placebo
plus chemotherapy followed by placebo, met its primary endpoint of
progression-free survival (PFS), with a statistically significant
and clinically meaningful benefit observed in both the overall
patient population and in a subpopulation of patients with mismatch
repair proficient/microsatellite stable (MMRp/MSS)
tumours.
Hesham Abdullah, Senior Vice President, Global Head Oncology,
R&D, GSK, said: "Patients with MMRp/MSS primary advanced or
recurrent endometrial cancer have few approved treatment options.
Today's positive topline results reinforce our approach of building
combination therapies with dostarlimab as the backbone in an effort
to improve patient outcomes and options."
Analysis
of the full trial data, including the key secondary endpoint of
overall survival (OS), is ongoing. OS data is immature and will
continue to be followed.
The safety profile of dostarlimab plus carboplatin and paclitaxel,
followed by dostarlimab plus niraparib, was generally consistent
with the known safety profiles of the individual
agents.
Full
results from this analysis will be presented at an upcoming
scientific meeting, published in a medical journal, and shared with
regulatory authorities.
About endometrial cancer
Endometrial
cancer is found in the inner lining of the uterus, known as the
endometrium. Endometrial cancer is the most common gynaecologic
cancer in developed countries, with approximately 417,000 new cases
reported each year worldwide[1], and incidence
rates are expected to rise by almost 40% between 2020 and
2040.[2][3] Approximately
15-20% of patients with endometrial cancer will be diagnosed with
advanced disease at the time of diagnosis.[4]
About RUBY
RUBY is
a two-part global, randomised, double-blind, multicentre phase III
trial of patients with primary advanced or recurrent endometrial
cancer. Part 1 is evaluating dostarlimab plus
carboplatin-paclitaxel followed by dostarlimab versus
carboplatin-paclitaxel plus placebo followed by placebo. Part 2 is
evaluating dostarlimab plus carboplatin-paclitaxel followed by
dostarlimab plus niraparib versus placebo plus
carboplatin-paclitaxel followed by placebo.
In Part 1, the dual-primary endpoints are investigator-assessed PFS
based on the Response Evaluation Criteria in Solid Tumours v1.1 and
OS. The statistical analysis plan included pre-specified analyses
of PFS in the mismatch repair deficient/microsatellite
instability-high (dMMR/MSI-H) and overall populations and OS in the
overall population. Pre-specified analyses of PFS and OS in the
MMRp/MSS population and OS in the dMMR/MSI-H populations were also
performed; however, they were not part of the hypothesis testing
strategy. RUBY Part 1 included a broad population, including
histologies often excluded from clinical trials and had
approximately 10% of patients with carcinosarcoma and 20% with
serous carcinoma.
In Part
2, the primary endpoint is investigator-assessed PFS in the overall
population, followed by PFS in the MMRp/MSS population, and OS in
the overall population is a key secondary endpoint. Additional
secondary endpoints in Part 1 and Part 2 include PFS per blinded
independent central review, overall response rate, duration of
response, disease control rate, patient-reported outcomes, and
safety and tolerability.
RUBY is
part of an international collaboration between the European Network
of Gynaecological Oncological Trial groups (ENGOT), a research
network of the European Society of Gynaecological Oncology (ESGO)
that consists of 22 trial groups from 31 European countries that
perform cooperative clinical trials, and the GOG Foundation, a
non-profit organisation dedicated to transforming the standard of
care in gynaecologic oncology.
About Jemperli (dostarlimab)
Jemperli is a programmed death receptor-1
(PD-1)-blocking antibody that binds to the PD-1 receptor and blocks
its interaction with the PD-1 ligands PD-L1 and
PD-L2. [5]
In the US, Jemperli is
indicated in combination with carboplatin and paclitaxel, followed
by Jemperli as
a single agent for the treatment of adult patients with primary
advanced or recurrent endometrial cancer that is dMMR, as
determined by a US FDA-approved test, or MSI-H, and as a single
agent for adult patients with dMMR recurrent or advanced
endometrial cancer, as determined by a US FDA-approved test, that
has progressed on or following a prior platinum-containing regimen
in any setting and are not candidates for curative surgery or
radiation. The supplemental Biologics License Application
supporting the new indication in combination with carboplatin and
paclitaxel received Breakthrough Therapy designation from the US
FDA. Jemperli is
also indicated in the US for patients with dMMR recurrent or
advanced solid tumours, as determined by a US FDA-approved test,
that have progressed on or following prior treatment and who have
no satisfactory alternative treatment options. The latter
indication is approved in the US under accelerated approval based
on tumour response rate and durability of response. Continued
approval for this indication in solid tumours may be contingent
upon verification and description of clinical benefit in a
confirmatory trial(s).
Jemperli was discovered
by AnaptysBio, Inc. and licensed to TESARO, Inc., under a
collaboration and exclusive license agreement signed in March 2014.
Under this agreement, GSK is responsible for the ongoing research,
development, commercialisation, and manufacturing
of Jemperli, and cobolimab (GSK4069889), a TIM-3
antagonist.
Important Information for Jemperli in the EU
Indication
Jemperli is indicated:
●
in
combination with carboplatin-paclitaxel, for the treatment of adult
patients with mismatch repair deficient (dMMR)/microsatellite
instability-high (MSI-H) primary advanced or recurrent endometrial
cancer and who are candidates for systemic
therapy;
●
as
monotherapy for treating adult patients with mismatch repair
deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent
or advanced endometrial cancer that has progressed on or following
prior treatment with a platinum-containing
regimen.
Refer to the Jemperli EMA Reference
information
(https://www.ema.europa.eu/en/medicines/human/EPAR/jemperli) for a
full list of adverse events and the complete important safety
information in the EU.
About Zejula (niraparib)
Zejula is an oral, once-daily poly(ADP-ribose)
polymerase (PARP) inhibitor indicated in the US for the maintenance
treatment of adult patients with advanced epithelial ovarian,
fallopian tube, or primary peritoneal cancer who are in complete or
partial response to first-line platinum-based chemotherapy;
and for the maintenance treatment of adult patients
with deleterious or suspected deleterious
germline BRCA-mutated recurrent epithelial ovarian, fallopian
tube, or primary peritoneal cancer who are in a complete or partial
response to platinum-based chemotherapy and who have been selected
based on a US FDA-approved companion diagnostic
for Zejula.
Zejula is currently being evaluated in multiple pivotal
trials. GSK continues to build a robust clinical development
programme by assessing activity across multiple tumour types and
evaluating several potential combinations
of Zejula with other therapeutics. Aiming to address
the unmet medical needs of patients, the ongoing development
programme includes several combination studies, including the FIRST
phase III trial assessing niraparib in combination with dostarlimab
as a potential treatment for first-line ovarian cancer maintenance
and the phase III ZEAL trial assessing niraparib in combination
with standard of care for the maintenance treatment of first-line
advanced non-small cell lung cancer.
Important Information for Zejula in the EU
Indication
Zejula is
indicated:
●
as
monotherapy for the maintenance treatment of adult patients with
advanced epithelial (FIGO Stages III and IV) high-grade ovarian,
fallopian tube or primary peritoneal cancer who are in response
(complete or partial) following completion of
first-line platinum-based
chemotherapy.
●
as
monotherapy for the maintenance treatment of adult patients with
platinum-sensitive relapsed high-grade serous epithelial ovarian,
fallopian tube, or primary peritoneal cancer who are in response
(complete or partial) to platinum-based
chemotherapy.
Refer to the Zejula EMA
Reference
Information (https://www.ema.europa.eu/en/medicines/human/EPAR/zejula)
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.
GSK enquiries
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Media:
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Tim
Foley
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Dan
Smith
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(London)
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Kathleen
Quinn
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(Washington
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Lyndsay
Meyer
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+1 202
302 4595
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(Washington
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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)
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Mick
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Camilla
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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] Faizan U, Muppidi V. Uterine Cancer. [Updated
2022 Sep 5]. In: StatPearls [Internet]. Treasure Island (FL):
StatPearls Publishing; 2022 Jan-. Available at:
https://www.ncbi.nlm.nih.gov/books/NBK562313/.
[2] Braun MM, et al. Am Fam
Physician. 2016;93(6):468-474.
[3] International Research on Cancer. Global Cancer
Observatory. Cancer Tomorrow.
https://gco.iarc.fr/tomorrow/en/dataviz/. Accessed 13 July 2022.
[4] Kantar Health, Cust Study
(2018).
[5] Laken H, Kehry M, Mcneeley P, et al.
Identification and characterization of TSR-042, a novel anti-human
PD-1 therapeutic antibody. European Journal of Cancer.
2016;69,S102.
doi:10.1016/s0959-8049(16)32902-1.
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: December
18, 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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