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: 24 October 2026, London UK
Jemperli
(dostarlimab) data show 76% of
patients with MSI-H/dMMR locally advanced rectal cancer achieved a
complete response
●
Patients
had no evidence of cancer following treatment with Jemperli alone,
confirmed by endoscopy, radiology and/or pathology
●
No
disease recurrences reported among responders after median
follow-up of more than two years
●
Data supported recent US approval of
Jemperli
in this indication
●
Findings
to be presented in a late-breaking oral session at
ESMO
GSK plc (LSE/NYSE: GSK) today announced positive interim results
from the phase II AZUR-1 trial evaluating Jemperli (dostarlimab) monotherapy as a standalone
treatment approach in adults with stage II and III microsatellite
instability-high (MSI-H)/mismatch repair deficient (dMMR) locally
advanced rectal cancer. The results will be presented in a
late-breaking oral session at the European Society for Medical
Oncology (ESMO) Congress.
In an exploratory analysis, 76% of evaluable patients (110/144; 95%
CI: 69%, 83%) achieved a complete response to dostarlimab alone.
This included 68% (98/144; 95% CI: 60%, 76%) who achieved a
sustained clinical complete response for at least 12 months (cCR12)
without surgery as assessed by investigators, and 12 additional
patients whose complete response was confirmed through tissue
analysis showing no evidence of cancer following surgery
(pathological complete response or pCR). No disease recurrences
have been reported among responders to date after a median
follow-up of more than two years.
Current standard of treatment for locally advanced rectal cancer
includes chemotherapy, radiation and surgery1,
but these can have lasting consequences, including bowel, urinary
and sexual dysfunction, secondary cancers and
infertility.2,3
Hesham Abdullah, Senior Vice President, Global Head of Oncology,
R&D, GSK, said: “The
AZUR-1 data demonstrate the potential for Jemperli alone to transform treatment for eligible patients
with MSI-H/dMMR locally advanced rectal cancer. For some patients,
avoiding chemotherapy, radiation and surgery may now be possible.
The recent US approval of Jemperli is a major advance in how this
disease may be treated for some
patients.”
Dr Andrea Cercek, MD, Section Head of Colorectal Cancer and
Co-Director of the Center for Young Onset Colorectal and
Gastrointestinal Cancer, Memorial Sloan Kettering Cancer Center,
and Principal Investigator of AZUR-1, said: “The AZUR-1 data presented show the global
results of the high rate of non-operative management in patients
with MSI-H/dMMR locally advanced rectal cancer treated with
dostarlimab. The fact that there have been no disease recurrences
to date after more than two years of follow-up should provide
physicians with confidence in an organ preservation approach in
this patient population.”
AZUR-1 met its primary objective, demonstrating that a clinically
significant proportion of patients achieved cCR12.
Data on the primary endpoint, cCR12 assessed by independent central
review, continue to mature. At the time of analysis, 47% of
evaluable patients (54/116; 95% CI: 37%, 56%) had achieved cCR12.
An additional 38 participants had already achieved a clinical
complete response but had not yet reached the 12-month assessment
timepoint and remained under observation.
The safety profile of dostarlimab was generally consistent with its
established profile across solid tumours. Serious adverse reactions
occurred in 20% of patients receiving Jemperli, and the most common
adverse reactions were fatigue (32%), rash (22%), diarrhoea (18%)
and pruritus (17%). Jemperli was permanently discontinued due to
adverse reactions in 3% of patients.
Regulatory reviews are ongoing in participating countries through
Project Orbis, an FDA Oncology Center of Excellence initiative
designed to facilitate concurrent review by international health
authorities.
About stage II/III MSI-H/dMMR locally advanced rectal
cancer
Around 5–10% of rectal cancers are microsatellite
instability-high (MSI-H) or mismatch repair-deficient
(dMMR)1.
These tumours have a specific genetic characteristic where they are
unable to properly repair DNA damage, leading to an accumulation of
mutations. This unique biological feature often makes them highly
responsive to immunotherapies like dostarlimab.2,3
These biomarkers are commonly found in
colorectal, endometrial and other gastrointestinal cancers, but can
also be present in other solid tumours.,,,4
About AZUR-1
AZUR-1 is a global, open-label, single-arm, registrational phase II
trial evaluating dostarlimab monotherapy in patients (n=154) with
previously untreated stage II and III MSI-H/dMMR locally advanced
rectal cancer. The trial was designed to assess clinical complete
responses sustained for 12 months (cCR12) as determined by
Independent Central Review, and to determine whether dostarlimab
alone could enable patients to avoid chemotherapy, radiation and
surgery. Additional efficacy outcomes include cCR12 based on
investigator assessment and objective response rate (ORR), defined
as patients who achieved cCR, clinical near-complete response, or
clinical partial response as their best overall response. Patients
received nine cycles of dostarlimab over six months, administered
as a 500mg intravenous infusion every three weeks. The safety and
tolerability profile of dostarlimab was generally consistent with
its well-characterised safety profile observed across solid
tumours. Serious adverse reactions occurred in 20% of patients
receiving Jemperli and treatment was permanently discontinued due
to adverse reactions in 3% of patients. The most common adverse
reactions (≥15%) were fatigue, rash, diarrhoea, and
pruritus.
About Jemperli (dostarlimab)
Jemperli, a programmed
death receptor-1 (PD-1)-blocking antibody, plays an important role
in GSK’s immune-oncology research and development programme.
A robust clinical trial programme includes studies
of Jemperli alone and in combination with other
therapies in gynaecologic, colorectal, and head and neck
cancers, as well as where there are opportunities for
transformational outcomes.
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.
More information about the product and its currently approved
indications is available at EU
product information5
and
US
product information.6
GSK in oncology
GSK develops differentiated medicines for cancers where advances in
science and technology offer the greatest opportunity to improve
patient outcomes across haematological, lung, gastrointestinal,
genitourinary and gynaecological cancers. Across multiple
modalities, including targeted small molecules, antibody-drug
conjugates (ADCs) and immunotherapies, we apply deep expertise in
cancer biology and immune system science to develop 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.
|
GSK enquiries
|
|
|
|
|
Media:
|
Tim
Foley
|
+44 (0)
20 8047 5502
|
(London)
|
|
|
Sarah
Clements
|
+44 (0)
20 8047 5502
|
(London)
|
|
|
Kathleen
Quinn
|
+1 202
603 5003
|
(Washington
DC)
|
|
|
Alison
Hunt
|
+1 540
742 3391
|
(Washington
DC)
|
|
|
Stephanie
Caccomo
|
+1 202
893 2840
|
(Washington
DC)
|
|
Investor
Relations:
|
James
Dodwell
|
+44 (0)
7881 269066
|
(London)
|
|
|
Mick
Readey
|
+44 (0)
7990 339653
|
(London)
|
|
|
Joanna
Tuplin
|
+44 (0)
7788 351650
|
(London)
|
|
|
Sam
Piper
|
+44 (0)
7824 525779
|
(London)
|
|
|
Dan
Smith
|
+44 (0)
7823 523885
|
(London)
|
|
|
Jeff
McLaughlin
|
+1 215
751 7002
|
(Philadelphia)
|
|
|
Frannie
DeFranco
|
+1 215
751 3126
|
(Philadelphia)
|
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.
Cercek
A, et al. Mismatch Repair-Deficient Rectal Cancer and Resistance to
Neoadjuvant Chemotherapy. Clin Cancer Res. 2020 Jul
1;26(13):3271-3279. doi: 1158/1078-0432.CCR-19-3728. Epub 2020 Mar
6. PMID: 32144135; PMCID: PMC7348681.
2.
Andre
T, Berton D, Curigliano G, et al. Antitumor Activity and Safety of
Dostarlimab Monotherapy in Patients With Mismatch Repair Deficient
Solid Tumors: A Nonrandomized Controlled Trial. JAMA Netw Open.
2023;6(11):e2341165.
doi:10.1001/jamanetworkopen.2023.41165.
3.
Le
DT, et al. PD-1 blockade in tumors with mismatch repair deficiency.
N Engl J Med. 2015;372(26):2509-2520.
4.
National
Cancer Institute at the National Institutes of Health. Definition
of mismatch repair deficiency. Accessed September 2026. Available
at:
https://www.cancer.gov/publications/dictionaries/cancer-terms/def/mismatch-repair-deficiency
5.
JEMPERLI
(dostarlimab) Summary of Product Characteristics. GlaxoSmithKline
(Ireland) Limited. Available at:
https://www.ema.europa.eu/en/medicines/human/EPAR/jemperli.
Accessed October 2026.
6.
JEMPERLI
(dostarlimab-gxly) prescribing information. GlaxoSmithKline.
Available at: https://gskpro.com/en-us/products/jemperli/. Accessed
October 2026.
Memorial Sloan Kettering Cancer Center Disclosure: Dr Cercek has
financial interests related to GSK.
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.
|
|
GSK plc
|
|
|
(Registrant)
|
|
|
|
|
Date: October
26, 2026
|
|
|
|
|
|
|
By:/s/ VICTORIA
WHYTE
--------------------------
|
|
|
|
|
|
Victoria Whyte
|
|
|
Authorised
Signatory for and on
|
|
|
behalf
of GSK plc
|
