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 2024
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 December 2024, London UK
GSK announces FIRST trial met its primary endpoint of progression
free survival in first line advanced ovarian cancer
●
Addition of Jemperli (dostarlimab)
to both platinum-based chemotherapy and Zejula (niraparib)
maintenance, with or without bevacizumab, demonstrated a
statistically significant effect on progression free survival
(PFS) versus active comparator arm
GSK plc (LSE/NYSE: GSK) today announced headline results from
the FIRST-ENGOT-OV44 phase III trial
evaluating Zejula (niraparib)
and Jemperli (dostarlimab)
in first line advanced ovarian cancer. The trial met its primary
endpoint of PFS demonstrating a statistically significant
difference with the addition of dostarlimab to both standard of
care carboplatin-paclitaxel chemotherapy and niraparib maintenance,
with or without bevacizumab.
Hesham Abdullah, Senior Vice President, Global Head Oncology,
R&D, GSK, said: "As
part of our focus in gynaecological cancers, we continue to
evaluate the potential of this combination and look forward to
sharing full results from the trial."
The key secondary endpoint of overall survival did not meet
statistical significance. Further analyses are ongoing and
data will be shared with health authorities and presented at
an upcoming scientific meeting.
The safety and tolerability profile was generally consistent with
the known safety profiles of the individual agents.
About ovarian cancer
Ovarian cancer is the eighth most common cancer in women
worldwide.[1] Despite
high response rates to platinum-based chemotherapy in the
first-line setting, approximately 85% of patients will experience
disease recurrence. Once the disease recurs, it is rarely curable,
with decreasing time intervals to each subsequent
recurrence.
[2]
About the FIRST trial
The FIRST-ENGOT-OV44 trial is an international, double-blind, randomised
phase III ENGOT trial sponsored by GSK and led by GINECO, a French
cooperative group dedicated to gynecological oncology. FIRST is
investigating the addition of dostarlimab to both, standard of care
(SOC) platinum-based chemotherapy and niraparib maintenance, with
or without bevacizumab, as a first-line treatment of stage III or
IV nonmucinous epithelial ovarian cancer. Originally, participants
were randomised 1:1:2 into three groups: Arm 1: SOC chemotherapy
followed by placebo maintenance; Arm 2: SOC chemotherapy followed
by niraparib maintenance; Arm 3: SOC chemotherapy and dostarlimab
followed by niraparib and dostarlimab maintenance. Bevacizumab
could be added at the investigator's discretion across all arms.
Due to the approvals of PARP inhibitors in the first-line setting,
Arm 1 (n=193) was
closed and participants were subsequently randomized 1:2 to Arms
2 (n=
385) and
3 (n=
753) only.
The primary endpoint is investigator-assessed PFS in Arms 2 and 3.
Secondary endpoints include OS, PFS2, time to first and second
subsequent therapy.
ABOUT GINECO[3]
GINECO (Groupe
d'Investigateurs National pour l'Etude des Cancers de l'Ovaire et
du sein) is the French Cooperative Group in Oncology labelled by
INCa (Institut National du Cancer or French NCI) developing and
conducting gynecological and metastatic breast cancer clinical
trials at the national and international level. The GINECO group
was founded in 1993 and is member of international consortia such
as ENGOT and GCIG (Gynecologic Cancer
InterGroup).
About ENGOT[4]
The European Network for Gynaecological Oncological
Trial (ENGOT) groups is a research network of the European Society
of Gynaecological Oncology and was founded in Berlin in October
2007. Currently, ENGOT consists of 21 trial groups from 31 European
countries that perform cooperative clinical trials. ENGOT's
ultimate goal is to bring the best treatment to gynaecological
cancer patients through the best science and enabling every patient
in every European country to access a clinical
trial.
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 prgramme. A
robust clinical trial programme includes studies of Jemperli alone
and in combination with other therapies for 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 mismatch repair
proficient/microsatellite stable (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
Indications
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 (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.
Important Information
for Zejula in the EU
Indications
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
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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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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Madison
Goring
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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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Annabel
Brownrigg-Gleeson
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+44 (0)
7901 101944
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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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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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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. Worldwide Cancer Data. World Cancer Research
Fund. https://www.wcrf.org/cancer-trends/ovarian-cancer-statistics/.
Updated March 23, 2022. Accessed November 2024.
2. Lorusso D, Mancini M, Di Rocco R, Fontanelli R,
Raspagliesi F. The role of secondary surgery in recurrent ovarian
cancer [published online August 5, 2012]. Int J Surg
Oncol. 2012.
doi:10.1155/2012/613980. Accessed November
2024.
3. Association for Research on Cancers including
GINECO. Available at: https://www.arcagy.org/ Accessed
20 November 2024.
4. European Network of Gynaecological Oncological
Trial groups. Available at: https://engot.esgo.org/ Accessed
20 November 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: December
20, 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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