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 2026
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: 23 October 2026, London UK
GSK presents positive data for Mo-Rez in platinum-resistant ovarian
cancer
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62%
confirmed objective response rate and 12.2-month median duration of
response in phase Ib trial
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11.1-month
median progression-free survival in a difficult-to-treat
setting
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Five
pivotal phase III studies now underway across gynaecological
cancers
GSK plc (LSE/NYSE: GSK) today announced updated data from the
global phase I BEHOLD-1 trial for mocertatug rezetecan (Mo-Rez), an
investigational B7-H4-targeted antibody-drug conjugate (ADC).
Results showed clinically meaningful and durable responses at
>13 months follow-up, building on initial data in
platinum-resistant ovarian cancer (PROC) announced earlier this
year. These data will be presented in a late-breaking oral session
at the European Society for Medical Oncology (ESMO) Congress 2026
in Madrid, Spain.[1]
Mo-Rez achieved a confirmed objective response rate (cORR)
of 62% (n=28/45; 95% confidence interval [CI]:
46.5-76.2%), with a median duration of response (DoR) of 12.2
months (95% CI: 7.0-12.7) at the selected phase III dose of 5.8
mg/kg. Median progression-free survival (PFS) was 11.1 months (95%
CI: 8.3-13.9).1
Hesham Abdullah, Senior Vice President, Global Head Oncology,
R&D, GSK, said:
“Current treatment options for patients with
platinum-resistant ovarian cancer are limited and achieving durable
responses remains a challenge. These promising results for Mo-Rez
show that treatment responses and durability are maintained over
time in many patients, alongside encouraging progression-free
survival and a manageable safety profile. We have accelerated the
phase III development programme across gynaecological cancers, with
five pivotal studies now underway.”
Safety results remain consistent with previously published
data.
[2]
Grade ≥3 treatment-related
adverse events (TRAEs) were observed in 71% (n=32/45) of
patients and were predominantly haematologic. At the selected phase
III dose, TRAEs led to treatment discontinuation
in 2% (n=1/45) of patients treated and interstitial lung
disease (ILD)/pneumonitis occurred in 2% (n=1/45) of
patients.1
Vanda Salutari, Study Investigator for BEHOLD-1, Innovative
Therapies Unit for Female Cancers, Department of Women and Child
Health, Fondazione Policlinico Universitario Agostino Gemelli
IRCCS, Rome, Italy said:
“Despite advances in ovarian cancer, platinum-resistant
disease is one of the hardest to treat, and many patients still
experience limited benefit from available treatment options. The
duration of response and progression-free survival observed in
BEHOLD-1 are particularly encouraging relative to what is typically
seen in this setting where prolonged disease control remains
difficult to achieve.”
B7-H4 is an immune checkpoint that is widely expressed in
gynaecological cancers and is low in normal tissues. The
responses to Mo-Rez observed across a range of B7-H4 expression
levels support its broad potential in gynaecological cancers and an
accelerated large-scale phase III programme is now underway in
ovarian and endometrial cancers.
Additional data from the BEHOLD programme being presented at ESMO
include an exploratory biomarker analysis from BEHOLD-1 showing
responses across a range of B7-H4 expression levels and study
designs for the phase III BEHOLD-Ovarian01 and BEHOLD-Endometrial01
studies.[3],[4],[5]
The BEHOLD-1 results support the
selected 5.8 mg/kg dose being evaluated in the phase III
development programme.
About the BEHOLD clinical trial programme
The BEHOLD clinical programme is GSK’s global development
plan that includes the BEHOLD-1 (NCT06431594) monotherapy study and
the ongoing BEHOLD-2 (NCT06796907) combination
study.
Five pivotal phase III trials are currently underway:
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Platinum-resistant
ovarian cancer (BEHOLD-Ovarian01 / NCT07286266)
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Platinum-sensitive
ovarian cancer (BEHOLD-Ovarian02 / NCT07684612)
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First-line
maintenance setting for ovarian cancer without homologous
recombination deficiency (BEHOLD-Ovarian03 /
NCT07694427)
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Second-line
advanced and recurrent endometrial cancer (BEHOLD-Endometrial01 /
NCT07286331)
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First-line
maintenance setting mismatch repair proficient endometrial cancer
(BEHOLD-Endometrial02 / NCT07684599).
About BEHOLD-1
The BEHOLD-1 clinical trial is a two-part, open-label, phase I
study evaluating the safety, tolerability and efficacy of Mo-Rez
injection in patients with platinum-resistant ovarian cancer (PROC)
or advanced/recurrent endometrial cancer (EC). Phase Ia assessed up
to four Mo-Rez dose levels in patients with advanced solid tumours,
with intravenous administration every three weeks until progression
or toxicity. In the phase Ib dose expansion, patients with PROC or
EC (1-3 prior lines of therapy) were randomised to three or two
Mo-Rez dose levels, respectively.
At data cut-off, a total of 136 PROC patients were enrolled in
BEHOLD-1. At the selected phase III dose evaluated in phase Ib, the
most common adverse events in PROC were gastrointestinal and
haematological, consistent with treatments in this class.
Treatment-related adverse events led to dose interruptions in 51%
of patients with PROC and dose reductions in 47%. Primary endpoints
included: incidence of dose-limiting toxicity in phase Ia and
confirmed objective response rate (cORR) by investigator per RECIST
1.1 in phase Ib. Patients with EC treated at the selected phase III
dose continue to be followed, with data expected to be presented in
the future.
About mocertatug rezetecan
Mo-Rez is a novel investigational B7-H4-targeted antibody-drug
conjugate designed to optimise efficacy and tolerability. It is
composed of a fully human anti-B7-H4 monoclonal antibody covalently
linked to a topoisomerase inhibitor payload and has a
drug-to-antibody ratio (DAR) of 6. GSK acquired exclusive worldwide
rights (excluding mainland China, Hong Kong, Macau and Taiwan) from
Hansoh Pharma to progress clinical development and
commercialisation of Mo-Rez globally.
About ovarian cancer
Ovarian cancer affects 843,000 people with 240,000 new cases
annually.[6] 70%
of people living with ovarian cancer will present with advanced
disease and survival usually declines after
recurrence.[7],[8] Patients
with platinum-resistant ovarian cancer (PROC), one of the hardest
to treat, face limited treatment options and poor
outcomes.[9]
Many will develop resistance to
platinum-based chemotherapy, the backbone of first-line treatment,
underscoring the need for innovations that can deliver meaningful
benefit.9
GSK in oncology
GSK is focused on developing differentiated medicines for cancers
where patients continue to face poor outcomes, treatment
resistance, limited options or significant treatment burden. We
focus where advances in science and technology offer the greatest
opportunity to improve outcomes across haematological, lung,
gastrointestinal, genitourinary and gynaecological cancers. Across
multiple modalities, including targeted small molecules,
antibody-drug conjugates (ADCs) and immunotherapies, GSK applies
deep expertise in cancer biology and immune system science to
develop differentiated medicines designed to deliver durable
responses, overcome resistance and reduce treatment
burden.
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 www.gsk.com.
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GSK enquiries
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Media:
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(London)
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Kathleen
Quinn
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+1 202
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(Washington
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Alison
Hunt
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+1 540
742 3391
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(Washington
DC)
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Investor
Relations:
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James
Dodwell
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+44 (0)
7881 269066
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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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Joanna
Tuplin
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+44 (0)
7788 351650
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(London)
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Sam
Piper
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+44 (0)
7824 525779
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(London)
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Dan
Smith
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+44 (0)
7823 523885
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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 3126
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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 in the “Risk
Factors” section in GSK’s Annual Report on Form 20-F
for 2025, and GSK’s Q2 Results for 2026.
Registered in England & Wales:
No.
3888792
Registered Office:
79
New Oxford Street
London
WC1A
1DG
References
[1]
Salutari V. Mocertatug rezetecan
(Mo-Rez) in patients with platinum-resistant ovarian cancer (PROC):
Updated results with longer follow-up from the global BEHOLD-1
study. Presented at the European Society for Medical Oncology
(ESMO) Congress 2026. October 2026.
[2]
Oaknin A, McKean W, van Dongen M, et
al. Mocertatug rezetecan (GSK5733584), a B7-H4 targeted antibody
drug conjugate, in platinum-resistant ovarian cancer and
endometrial cancer: First results from the global BEHOLD-1 study.
Presented at the Society of Gynecologic Oncology (SGO) Annual
Meeting on Women’s Cancer 2026. April
2026.
[3]
Lheureux S. BEHOLD-1: Exploratory
analysis of biomarkers associated with mocertatug rezetecan
(Mo-Rez) response in patients with platinum-resistant ovarian
cancer (PROC). Presented at the European Society for Medical
Oncology (ESMO) Congress 2026. October 2026.
[4]
Backes F. BEHOLD-Ovarian01: A Phase 3
randomised trial to evaluate mocertatug rezetecan (Mo-Rez) versus
standard of care (SoC) in patients (pts) with platinum-resistant
ovarian cancer (PROC). Presented at the European Society for
Medical Oncology (ESMO) Congress 2026. October
2026.
[5]
Oaknin A. BEHOLD-Endometrial01: A
randomised Phase 3 study evaluating the efficacy and safety of
mocertatug rezetecan (Mo-Rez) versus chemotherapy in patients with
advanced or recurrent endometrial cancer after platinum-based
therapy and immunotherapy. Presented at the European Society for
Medical Oncology (ESMO) Congress 2026. October
2026.
[6]
Ren Y, Xu R, Wang Y, et al. Global,
regional, and national burden of ovarian cancer in women aged
45 + from 1990 to 2021 and projections for 2050: a
systematic analysis based on the 2021 global burden of disease
study. J Cancer Res Clin Oncol.
2025;151(8):225.
[7]
Rauh-Hain JA, Krivak TC, Del Carmen
MG, Olawaiye AB. Ovarian cancer screening and early detection in
the general population. Rev Obstet Gynecol.
2011;4(1):15-21.
[8]
Salas Bolívar P, Gonzalez-Benitez
C, Carbonell López M, et al. Prognostic factors after the
first recurrence of ovarian cancer. Journal of Clinical Medicine.
2025;14(2):470.
[9]
Eskander RN, Moore KN, Monk BJ, et al.
Overcoming the challenges of drug development in platinum-resistant
ovarian cancer. Front Oncol. 2023;13:1258228.
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
26, 2026
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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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