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 January 2025
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: 20 January 2025, London UK
European
Commission expands Jemperli (dostarlimab)
plus chemotherapy approval to all adult patients with primary
advanced or recurrent endometrial cancer
●
Expanded
approval includes MMRp/MSS tumours, which represent approximately
75% of endometrial cancer cases
●
Approval based on RUBY Part 1 trial, which showed
a median overall survival (OS) of 44.6 months
for Jemperli plus chemotherapy vs. 28.2 months for
chemotherapy alone
●
Jemperli plus
chemotherapy is the only immuno-oncology-based treatment to show
statistically significant and clinically meaningful OS benefit in
the overall population
GSK plc (LSE/NYSE: GSK) today announced the European Commission has
approved Jemperli (dostarlimab) in combination with
chemotherapy (carboplatin and paclitaxel) for first-line treatment
of adult patients with primary advanced or recurrent endometrial
cancer who are candidates for systemic therapy. This approval
broadens the previous indication for Jemperli plus chemotherapy in the European Union (EU)
to include patients with mismatch repair proficient
(MMRp)/microsatellite stable (MSS) tumours, which represent
approximately 75% of patients diagnosed with endometrial cancer and
who have limited treatment options.
Hesham Abdullah, Senior Vice President, Global Head Oncology,
R&D, GSK, said: "For
the first time, all patients with primary advanced or recurrent
endometrial cancer in the EU have an approved immuno-oncology-based
treatment that has shown a statistically significant and clinically
meaningful overall survival benefit. We're
proud Jemperli continues to redefine the treatment
landscape for patients."
Dr Mansoor Raza Mirza, Chief Oncologist, Copenhagen University
Hospital, Denmark, and RUBY principal investigator
said: "Clinicians
have been waiting for years for an immuno-oncology-based option
that can meaningfully improve overall survival outcomes for
patients with MMRp/MSS primary
advanced or recurrent endometrial cancer. The expanded approval
represents a significant advance that delivers on this hope, now
for patients with both dMMR/MSI-H and MMRp/MSS
tumours."
The European
Commission's approval to expand the use of Jemperli plus
chemotherapy is based on results from Part 1 of the RUBY phase III
trial. RUBY Part 1 is the only clinical trial in this setting
to show a clinically meaningful and statistically significant
overall survival (OS) benefit in the full population of patients
with primary advanced or recurrent endometrial
cancer, demonstrating a 31% reduction in risk of
death (HR: 0.69; 95% CI: 0.54-0.89) compared to chemotherapy
alone.
At the 2.5-year landmark, the chance of being alive was 61% (95%
CI: 54-67) for patients in the Jemperli plus chemotherapy group (245 patients)
compared to 49% (95% CI: 43-55) in the chemotherapy group (249
patients). In addition, a 16.4-month improvement in median OS was
observed with Jemperli plus chemotherapy versus chemotherapy alone
(44.6 months [95% CI: 32.6-NR] vs. 28.2 months [95% CI: 22.1-35.6],
respectively). The median duration of follow-up was more than three
years.[1] The
safety and tolerability analysis from RUBY Part 1 showed a safety
profile for Jemperli plus carboplatin-paclitaxel that was
generally consistent with the known safety profiles of the
individual agents. The most common treatment-emergent adverse
reactions (≥ 10%) in patients
receiving Jemperli plus chemotherapy were rash, rash
maculopapular, hypothyroidism, pyrexia, alanine aminotransferase
increased, aspartate aminotransferase increased and dry
skin.
OS data were presented at the Society of Gynecologic
Oncology Annual Meeting on Women's Cancer on 16 March
2024
[2],
and were published in Annals
of Oncology on
9 June 2024[3]. The
label for Jemperli plus
chemotherapy in the US was expanded to all
adult patients with primary advanced or recurrent endometrial
cancer in August 2024.
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,[4] with an
estimated 1.6 million people living with active disease at any
stage and 417,000 new cases reported each year
worldwide.[5] Incidence
rates are expected to rise by approximately 40% between 2020 and
2040.[6] In
Europe, approximately 121,000 people are estimated to be diagnosed
with primary advanced or recurrent endometrial cancer each
year.[7] Approximately
15-20% of patients with endometrial cancer will be diagnosed with
advanced disease at the time of diagnosis.[8] Among
patients with primary advanced or recurrent endometrial cancer,
approximately 75% have MMRp/MSS tumours.[9]
About RUBY
RUBY is a two-part global, randomised, double-blind, multicentre
phase III trial of 785 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
progression-free survival (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 (dMMR)/microsatellite instability-high (MSI-H) and
overall 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 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, PFS2, 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, a programmed death
receptor-1 (PD-1)-blocking antibody, is the backbone of GSK's
ongoing immuno-oncology-based research and development programme. A
robust clinical trial programme includes studies
of Jemperli alone and in combination with other
therapies in gynaecologic, colorectal and lung cancers, as well as
where there are opportunities for transformational
outcomes.
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. This
includes patients
with MMRp/MSS and dMMR/MSI-H tumours. Jemperli is
also approved 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.
Additionally, Jemperli is
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 and paclitaxel,
for the first-line treatment of adult patients with 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 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
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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Investor
Relations:
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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] Powell
MA, Bjørge L, Willmott L, et al. Overall
survival in patients with endometrial cancer treated with
dostarlimab plus carboplatin-paclitaxel in the randomized
ENGOT-EN6/GOG-3031/RUBY trial, Annals of Oncology.2024. doi:
https:// doi.org/10.1016/j.annonc.2024.05.546.
[2] https://www.gsk.com/en-gb/media/press-releases/positive-ruby-phase-iii-data-show-potential-for-jemperli-dostarlimab-combinations-in-more-patients-with-primary-advanced-or-recurrent-endometrial-cancer/
[3] Powell
MA, Bjørge L, Willmott L, et al. Overall survival in patients
with endometrial cancer treated with dostarlimab plus
carboplatin-paclitaxel in the randomized ENGOT-EN6/GOG-3031/RUBY
trial, Annals of Oncology.2024. doi: https://
doi.org/10.1016/j.annonc.2024.05.546.
[4] Faizan
U, Muppidi V. Uterine Cancer. [Updated 2022 Sep 5]. In: StatPearls
[Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan.
Available at:
www.ncbi.nlm.nih.gov/books/NBK562313/.
[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] International
Research on Cancer. Global Cancer Observatory. Cancer Tomorrow.
Gco.iarc.fr/tomorrow/en/dataviz/. Accessed 04 October
2024.
[7] Concin N, Matias-Guiu X, Vergote I,
et al ESGO/ESTRO/ESP guidelines for the
management of patients with endometrial
carcinoma International
Journal of Gynecologic Cancer 2021;31:12-39.
[8] CMP:
CancerMPact® Patient Metrics Mar-2023, Cerner
Enviza. Available
at www.cancermpact.com. Accessed 18 December
2024.
[9] Based
on CMP:CancerMPact® [Patient Metrics], Cerner Enviza.
Available from www.cancermpact.com. Accessed 18 December
2024.
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: January
20, 2025
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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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