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 April 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 . . . . . . . .
Strictly embargoed until Sunday 12 April 2026, 3:10 pm (BST) /
10:10 (AST)
GSK presents positive data for B7-H4-targeted ADC in gynaecological
cancers
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Mocertatug
rezetecan achieved confirmed objective response rates of 62% in
platinum-resistant ovarian cancer (PROC) and 67% in recurrent or
advanced endometrial cancer (EC) in BEHOLD-1
study
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Current
treatment options are limited for patients with PROC and
EC
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Promising
efficacy and safety profile supports start of five pivotal phase
III trials in 2026
GSK plc (LSE/NYSE: GSK) today announced positive findings from its
global phase 1 BEHOLD-1 clinical trial for mocertatug rezetecan (or
Mo-Rez for short), a novel antibody-drug conjugate (ADC) targeting
the B7-H4 antigen. At the highest doses evaluated, Mo-Rez
monotherapy achieved confirmed objective response rates (cORR) of
62% (5.8 mg/kg n=21/34; 95% CI: 44, 78) in platinum-resistant
ovarian cancer (PROC) and 67% (4.8 mg/kg n=8/12; 95% CI: 35, 90) in
recurrent or advanced endometrial cancer (EC).[1] These
data will be presented for the first time in a late-breaking oral
session at the Society of Gynecologic Oncology (SGO) Annual Meeting
on Women's Cancer in San Juan, Puerto Rico.
Currently, there are limited treatment options with modest response
rates for patients with PROC and advanced EC. B7-H4 is an immune
checkpoint that is widely expressed in ovarian and endometrial
cancers and is low in normal tissues, providing potential for a
differentiated precision-therapy. The response to Mo-Rez observed
across a range of B7-H4 expression levels reinforces its broad
potential in gynaecologic cancers and further validates the
relevance of targeting B7-H4.
Hesham Abdullah, Senior Vice President, Global Head Oncology,
R&D, GSK, said: "Treatment
of gynaecological cancers remains a major challenge, with a
pressing need for new therapies that offer improved response rates.
With Mo-Rez, we now have compelling evidence of a promising
clinical profile, with response rates that support accelerating
development into five pivotal global phase III trials later this
year across ovarian and endometrial cancers, including earlier-line
settings."
Ana Oaknin, Study Investigator for BEHOLD-1, Medical Oncology
Department, Hospital Universitario Puerta de
Hierro-Majadahonda, Madrid, Spain said: "In
the early phase BEHOLD-1 study, we saw meaningful antitumour
activity for this patient dataset, with response rates higher than
typically seen in ADCs in development, and a manageable safety
profile. For patients with platinum-resistant ovarian cancer and
recurrent endometrial cancer, these findings are particularly
encouraging."
At the highest doses evaluated in BEHOLD-1, few patients needed to
stop treatment because of a treatment-related adverse events (TRAE)
(0% in PROC and 4% in EC). The most common TRAE was nausea (82% in
PROC; 75% in EC). Grade ≥3 TRAEs occurred in 64% and 54%
patients in PROC and EC, respectively, and were predominantly
haematologic, as expected for treatments in this class. Overall
rates of interstitial lung disease or pneumonitis were low (3%; 5
out of 178 patients) and all cases were mild to moderate (grade
1-2). The interim analysis showed the median duration of response
had not yet been reached. Based on the findings from this study,
the recommended dose for the first of the phase III trials,
BEHOLD-Ovarian01 and BEHOLD-Endometrial01, is 5.8
mg/kg.
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. Mo-Rez will advance to five pivotal global phase III trials
in 2026, starting with PROC (BEHOLD-Ovarian01 / NCT07286266)
and 2L EC (BEHOLD-Endometrial01 / NCT07286331).
Additional phase III studies will evaluate Mo-Rez in platinum-sensitive ovarian cancer (BEHOLD-Ovarian02) and in
first-line maintenance settings for ovarian cancer
without homologous recombination deficiency (BEHOLD-Ovarian03) and
mismatch-repair-proficient endometrial cancer
(BEHOLD-Endometrial02).
About BEHOLD-1
The BEHOLD-1 clinical trial is a two-part, open-label, phase 1
study evaluating the safety, tolerability and efficacy of Mo-Rez
injection in patients with PROC or advanced/recurrent EC. Phase 1a
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 1b 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 224 patients were enrolled in BEHOLD-1;
n=44 in phase 1a (n=21 PROC, n=23 mix of other solid tumours) and
n=180 in phase Ib (n=131 PROC, n=49 EC). Primary endpoints
included: incidence of dose-limiting toxicity in phase 1a and
confirmed ORR (cORR) by investigator per RECIST 1.1 in phase Ib. At
the highest dose evaluated in phase Ib, the most common adverse
events in PROC were nausea (86%), neutropenia/neutrophil count
decreased (73%), anaemia (52%), fatigue (52%) and alopecia (52%).
In EC, the most common adverse events were nausea
(79%), neutropenia/neutrophil
count decreased (58%), anaemia (54%), vomiting (46%) and fatigue
(42%). Treatment-related adverse events led to dose interruptions
in 39% of patients with PROC and 21% of those with EC, and to dose
reductions in 39% in PROC and 17% in EC, at the highest dose. The
trial is ongoing and currently in the dose expansion
phase.
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 China's mainland, Hong Kong, Macau, and Taiwan)
from Hansoh Pharma to progress clinical development and
commercialisation of Mo-Rez globally.
About ovarian cancer and endometrial cancer
Endometrial cancer affects 1.6 million people globally, with
417,000 new cases each year and 15% to 20% of patients presenting
in later stages of the disease.[2],[3] Ovarian
cancer affects 843,000 people with 240,000 new cases
annually.[4] 70%
of these patients present with advanced disease.[5] Recurrence
is common in advanced cases of disease, up to 67% in endometrial
cancer and 70% in ovarian cancer, and survival usually declines
after recurrence.[6],[7]
GSK in oncology
Our ambition in oncology is to help increase overall quality of
life, maximise survival and change the course of disease, expanding
from our current focus on blood and women's cancers into lung and
gastrointestinal cancers, as well as other solid tumours. This
includes accelerating priority programmes such as antibody-drug
conjugates targeting B7-H3 and B7-H4, and IDRX-42, a highly
selective KIT tyrosine kinase inhibitor.
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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Media:
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Alison Hunt
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Investor Relations:
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Constantin Fest
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+44 (0) 7831 826525
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(London)
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James Dodwell
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+44 (0) 20 8047 2406
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Mick Readey
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+44 (0) 7990 339653
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+44 (0) 7796 707505
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Sam Piper
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+44 (0) 7824 525779
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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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(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 in the "Risk
Factors" section in GSK's Annual Report on Form 20-F for
2025.
Registered in England & Wales:
No.
3888792
Registered Office:
79
New Oxford Street
London
WC1A
1DG
References
[1] 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.
[2] 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.
[3] CMP: CancerMPact® Patient
Metrics Mar-2023, Cerner Enviza.
[4] Ren Y, Xu R, Wang Y, Su L, Su J.
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. 151(8):225.
doi:10.1007/s00432-025-06277-9.
[5] Rauh-Hain JA, Krivak TC, Del
Carmen MG et al. Ovarian cancer screening and
early detection in the general population. Rev Obstet Gynecol.
2011;4(1):15-21.
[6] Shelvin KB, Vincent J, Morron S,
Morin M, Mammoser A, Nair N. Recurrent high grade serous
endometrial cancer with brain metastases: Immunotherapy confers
improved quality of life and survival. Gynecol Oncol Rep.
2024;55:101494. doi:10.1016/j.gore.2024.101494.
[7] Salas Bolívar P,
Gonzalez-Benitez C, Carbonell López M, Díez Sebastian J,
Hernández Gutiérrez A, Zapardiel I. Prognostic Factors
After the First Recurrence of Ovarian Cancer. Journal of
Clinical Medicine. 2025; 14(2):470.
https://doi.org/10.3390/jcm14020470.
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: April
13, 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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