a6268r
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 October 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: 30 October 2023, London UK
Phase III RUBY trial
of Jemperli (dostarlimab) plus chemotherapy meets
endpoint of overall survival in patients with primary advanced or
recurrent endometrial cancer
●
Statistically
significant and clinically meaningful overall survival benefit
observed in the overall population in the trial
●
Dostarlimab
plus chemotherapy is the only immuno-oncology combination regimen
to show an overall survival benefit in this patient
population
GSK plc (LSE/NYSE: GSK) today
announced positive headline results from a planned analysis of Part
1 of the RUBY/ENGOT-EN6/GOG3031/NSGO phase III trial
investigating Jemperli (dostarlimab)
plus standard-of-care chemotherapy (carboplatin and paclitaxel),
followed by dostarlimab as a single agent, compared to placebo plus
chemotherapy followed by placebo in adult patients with primary
advanced or recurrent endometrial cancer. The trial met its primary
endpoint of overall survival (OS), demonstrating a statistically
significant and clinically meaningful benefit in the overall
patient population.
A clinically meaningful OS benefit was observed in both
prespecified subpopulations in the trial: mismatch repair deficient
(dMMR)/microsatellite instability-high (MSI-H) and mismatch repair
proficient (MMRp)/microsatellite stable (MSS) patient subgroups. OS
is one of two primary endpoints in the RUBY Part 1 trial.
Previously, the trial met its other primary endpoint of
progression-free survival (PFS), demonstrating a 72% and 36%
reduction in the risk of disease progression or death observed in
the dMMR/MSI-H population (HR: 0.28 [95% CI: 0.16-0.50]) and
overall patient population (HR: 0.64 [95% CI: 0.51-0.80]),
respectively[1].
Hesham Abdullah, Senior Vice President, Global Head Oncology,
R&D, GSK, said: "With
today's headline results from Part 1 of the phase III RUBY trial,
dostarlimab plus chemotherapy has become the only immuno-therapy
combination to show a survival benefit in this broader patient
population in this treatment setting. We look forward to sharing
detailed results of this analysis with regulatory authorities and
the larger scientific community."
Full results from this latest analysis from the trial will be
published in a medical journal and presented at an upcoming
scientific meeting.
The safety and tolerability profile of dostarlimab plus carboplatin
and paclitaxel was generally consistent with the known safety
profiles of the individual agents. The most common
treatment-emergent adverse events (≥ 25%) in patients
receiving dostarlimab plus chemotherapy were nausea, alopecia,
fatigue, peripheral neuropathy, anemia, arthralgia, constipation,
diarrhoea and myalgia.
Currently, Jemperli has
regulatory approvals in a certain subset of patients with
endometrial cancer based on the previously reported positive
results for the primary endpoint of progression-free survival in
Part 1 of the RUBY trial. In July 2023, Jemperli received
FDA approval 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 mismatch repair
deficient (dMMR), as determined by an FDA-approved test, or
microsatellite instability-high (MSI-H). Jemperli was
also approved in the United Kingdom in October 2023 in combination
with platinum-containing chemotherapy for the treatment of adult
patients with dMMR/MSI-H primary advanced or recurrent endometrial
cancer and who are candidates for systemic therapy. The application
remains under review in the European Union (EU), Australia, Canada,
Switzerland and Singapore.
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[[2]],
and incidence rates are expected to rise by almost 40% between 2020
and 2040.[[3]][[4]] Approximately
15-20% of patients with endometrial cancer will be diagnosed with
advanced disease at the time of diagnosis.[[5]]
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.
The dual-primary endpoints in Part 1 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 dMMR/MSI-H and ITT populations and OS in the overall
population. Pre-specified exploratory analyses of PFS and OS in the
MMRp/MSS population and OS in the dMMR/MSI-H populations were also
performed. 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. 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.
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.[[6]]
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 mismatch repair
deficient (dMMR), as determined by an FDA-approved test, or
microsatellite instability-high (MSI-H), and as a single
agent for
adult patients with
mismatch repair-deficient (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
sBLA supporting the indication in combination with carboplatin and
paclitaxel received Breakthrough Therapy designation from the
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.
The collaboration has resulted in three monospecific antibody
therapies that have progressed into the clinic. These
are: Jemperli (GSK4057190), a PD-1 antagonist; cobolimab,
(GSK4069889), a TIM-3 antagonist; and GSK4074386, a LAG-3
antagonist. GSK is responsible for the ongoing research,
development, commercialisation, and manufacturing of each of these
medicines under the agreement.
Important Information for Jemperli in
the EU
Indication
Jemperli is
indicated 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 for a full list of adverse events and the
complete important safety information in the EU
here: https://www.ema.europa.eu/en/medicines/human/EPAR/jemperli.
GSK in oncology
GSK is committed to maximising patient survival through
transformational medicines, with a current focus on breakthroughs
in immuno-oncology and tumor-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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Investor
Relations:
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Nick
Stone
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James
Dodwell
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Mountifield
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Frannie
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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 Q2 Results for 2023.
Registered in England & Wales:
No.
3888792
Registered Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
References
[1]Mirza M, et al. N Engl J Med
2023; 388:2145-2158; DOI: 10.1056/NEJMoa2216334
[2] 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/.
[3] Braun
MM, et al. Am Fam Physician. 2016;93(6):468-474.
[4] International
Research on Cancer. Global Cancer Observatory. Cancer Tomorrow.
https://gco.iarc.fr/tomorrow/en/dataviz/. Accessed
13 July 2022.
[5] Kantar
Health, Cust Study (2018).
[6] 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: October
30, 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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