GLAXF 6-K
GSK plc (GSK)
6-K
2026-07-13
For: 2026-07-13
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Added on
July 13, 2026
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 July 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: 13 July 2026, London UK
Jemperli (dostarlimab) achieves sustained clinical
complete responses in dMMR/MSI-H locally advanced rectal
cancer
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Primary
objective met in interim analysis, with clinically significant rate
of participants showing no detectable signs of cancer one year or
more after treatment
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Results
support potential for dostarlimab to eliminate the need for
chemotherapy, radiation and surgery in some
patients
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Data
to be shared with health authorities for regulatory review,
including accelerated review in the US
GSK plc (LSE/NYSE: GSK) today announced positive interim results
from the registrational phase II AZUR-1 trial
of Jemperli (dostarlimab) in patients with stage II/III
mismatch repair deficient/microsatellite instability-high
(dMMR/MSI-H) locally advanced rectal cancer. The single arm trial
met its primary objective, showing a meaningful and sustained
clinical complete response rate at 12 months
(cCR12).
These results support the potential for dostarlimab, if approved,
to become the first immunotherapy capable of eliminating
or delaying the need for chemotherapy, radiation and surgery for
some patients in this population.
Rectal cancer, a type of bowel cancer, affects around 730,000
people globally each year1 and approximately
5-10% of all rectal cancers have the dMMR/MSI-H
subtype2. Current
standard of care typically includes chemotherapy, radiation, and
surgery3.
While often effective, these treatments can profoundly impact a
patient's quality of life, potentially leading to lifelong use of a
colostomy bag, significant physiological dysfunction, and
infertility4,5,6.
Hesham Abdullah, Senior Vice President, Global Head Oncology,
R&D, GSK, said: "The
AZUR-1 results support the potential for dostarlimab to transform treatment for
dMMR/MSI-H locally advanced rectal cancer. For many patients
today, rectal cancer treatment
comes with the
tolerability burden and lasting impacts from chemotherapy,
radiation and surgery. These
data demonstrate that some patients may be able to avoid those
interventions while remaining free of detectable signs of
cancer."
AZUR-1 results represent a substantial improvement compared to the
historical standard of care7 and
build on earlier research conducted in collaboration with Memorial
Sloan Kettering Cancer Center, which first demonstrated the
potential for dostarlimab to achieve clinical complete responses
without other treatments in patients with dMMR/MSI-H locally
advanced rectal cancer.
In interim data, the safety and tolerability profile of dostarlimab
was consistent with its well-characterised and manageable safety
profile observed across solid tumours.
Dostarlimab has received both Breakthrough Therapy and Fast Track
designations from the US Food and Drug Administration (FDA) in this
setting. GSK plans to share interim AZUR-1 data with global
regulatory authorities to support review. Detailed results will be
presented at a future scientific congress.
About stage II/III dMMR/MSI-H locally advanced rectal
cancer
Around 5-10% of rectal cancers are mismatch repair-deficient (dMMR)
or microsatellite instability-high (MSI-H)8.
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 dostarlimab9,10. These
biomarkers are most commonly found in colorectal, endometrial and
other gastrointestinal cancers, but can also be present in other
solid tumours11.
About AZUR-1
AZUR-1 is a global, open-label, single-arm, registrational phase II
trial evaluating dostarlimab monotherapy in patients with stage
II/III dMMR/MSI-H locally advanced rectal cancer. The trial was
designed to assess sustained clinical complete responses for 12
months (cCR12) and determine whether dostarlimab alone could enable
patients to avoid chemotherapy, radiation and/or surgery. A total
of 154 participants received nine cycles of dostarlimab over six
months, administered as a 500 mg intravenous infusion every three
weeks.
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 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 Jemperli, its indications and complete important safety
information is available at EU
product information12 and US
product information13. Jemperli is
not currently approved anywhere in the world for rectal
cancer.
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 gynaecologic 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 velzatinib, 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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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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Alison Hunt
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+1 540 742 3391
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(Washington
DC)
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Kathleen Quinn
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+1 202 603 5003
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(Washington DC)
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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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(London)
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Mick Readey
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+44 (0) 7990 339653
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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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Sam Piper
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+44 (0) 7824 525779
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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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(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, and
GSK's Q1 Results for 2026.
Registered in England & Wales:
No.
3888792
Registered Office:
79
New Oxford Street
London
WC1A
1DG
References
1.
International Agency for Research on Cancer (IARC) (2024) Rectum
cancer fact sheet: GLOBOCAN 2022. World Health Organization.
Available at: https://gco.iarc.who.int/media/globocan/factsheets/cancers/9-rectum-fact-sheet.pdf.
Date accessed: June 2026
2.
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.
3.
Fadlallah, H., El Masri, J., Fakhereddine, H. et al. (2024)
'Colorectal cancer: Recent advances in management and treatment',
World Journal of Clinical Oncology, 15(9), pp. 1136-1156. Available
at: https://pmc.ncbi.nlm.nih.gov/articles/PMC11438855/
4. Cercek,
A., Lumish, M., Sinopoli, J. et al. (2022)
'PD-1
blockade in mismatch repair-deficient, locally advanced rectal
cancer', New England Journal of Medicine, 386(25), pp. 2363-2376.
Available at:
https://www.nejm.org/doi/full/10.1056/NEJMoa2201445
5.
Negro, S. et al. (2025) 'Quality of life in rectal cancer
treatments: a systematic review', Cancers, 17(14), 2310. Available
at: https://www.mdpi.com/2072-6694/17/14/2310
6. Neibart,
S.S. et
al. (2020)
'Quality of life after radiotherapy for rectal
cancer', Current
Colorectal Cancer Reports, 16(1), pp. 1-10. Available at:
https://pmc.ncbi.nlm.nih.gov/articles/PMC7336840/
7.
Cercek A, Roxburgh CS, Strombom P, et al. Adoption of Total
Neoadjuvant Therapy for Locally Advanced Rectal Cancer. JAMA Oncol.
2018;4(6):e180071. doi:10.1001/jamaoncol.2018.0071
8.
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
9.
Le DT, et al. PD-1 blockade in tumors with mismatch repair
deficiency. N Engl J Med. 2015;372(26):2509-2520.
10. 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.
11. National Cancer
Institute at the National Institutes of Health. Definition of
mismatch repair deficiency. Accessed June 2026. Available
at: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/mismatch-repair-deficiency
12.
JEMPERLI (dostarlimab) Summary of Product Characteristics.
GlaxoSmithKline (Ireland) Limited. Available at:
https://www.ema.europa.eu/en/medicines/human/EPAR/jemperli.
Accessed June 2026.
13.
JEMPERLI (dostarlimab-gxly) prescribing information.
GlaxoSmithKline. Available at:
https://gskpro.com/en-us/products/jemperli/. Accessed July
2026.
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: July
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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