GSK：Jemperli获FDA加速批准用于MSI-H/dMMR局晚期直肠癌，为该适应症首个免疫疗法

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6-K
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JEMPERLI APPROVED IN MSI-H/DMMR RECTAL CANCER
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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:
19 October 2026, London UK
Jemperli
(dostarlimab) approved in US as first and only immunotherapy for
adults with MSI-H/dMMR locally advanced rectal
cancer
●
Approval based on
AZUR-1 data showing clinically significant proportion of
participants with no detectable signs of cancer one year or more
after treatment
●
No disease
recurrences reported among responders after median follow up of
more than two years
●
Jemperli
monotherapy could help
eligible patients avoid chemotherapy, radiation and
surgery
GSK plc
(LSE/NYSE: GSK) today announced the US Food and Drug Administration
(FDA) has approved
Jemperli
(dostarlimab) as the first and only immunotherapy for adults with
stage II and III microsatellite instability-high (MSI-H)/mismatch
repair deficient (dMMR) locally advanced rectal cancer under the
accelerated approval pathway.
Current
standard of treatment for locally advanced rectal cancer includes
chemotherapy, radiation and surgery
1
, but these can have
lasting consequences, including bowel, urinary and sexual
dysfunction, secondary cancers and infertility
2,3
. For patients with
MSI-H/dMMR tumours, a biomarker found in around 5-10% of rectal
cancers
4
,
Jemperli
monotherapy could
help avoid these interventions.
Tony Wood, Chief Scientific Officer, GSK,
said:
“Today,
Jemperli
becomes the first and only
approved immunotherapy for adults in the US with MSI-H/dMMR locally
advanced rectal cancer. For decades, treatment has relied on
chemotherapy, radiation and surgery. This approval offers a new
treatment approach and represents an important step towards more
personalised care for these patients.”
Dr Andrea Cercek, MD, Principal Investigator of AZUR-1, Section
Head of Colorectal Cancer and Co-Director of the Center for Young
Onset Colorectal and Gastrointestinal Cancer, Memorial Sloan
Kettering Cancer Center, said:
“The AZUR-1 results
demonstrate the potential for a fundamentally different treatment
approach in this biomarker-defined patient population, and
today’s approval means MSI-H/dMMR patients can now access a
licensed treatment tailored to the biology of their
disease.”
Michael Sapienza, CEO, Colorectal Cancer Alliance, said:
“People facing rectal cancer are often thinking not only
about treating their disease, but also worrying about what life
will look like afterwards. The possibility of avoiding
chemotherapy, radiation and surgery represents a meaningful advance
for patients and their families. Biomarker testing at diagnosis
will be essential to identifying patients who may be eligible for
this treatment and helping them understand their
options.”
Approval
was based on data from the phase II AZUR-1 trial. The study met its
primary objective, demonstrating a clinically significant
proportion of participants achieved sustained clinical complete
responses at 12 months (cCR12), with data continuing to
mature.
Investigator-assessed
data, a clinically relevant endpoint, showed 68% of evaluable
patients (98/144; 95% CI: 60%, 76%) achieved cCR12. In an
exploratory analysis, 76% (110/144; 95% CI: 69%, 83%) of evaluable
patients had no evidence of cancer one year or more after
treatment. This includes 68% (98/144) (95% CI: 60%, 76%) of
patients who reached cCR12 without surgery, plus other participants
(n=12) who had their complete response confirmed through tissue
analysis after 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.
Data on
the primary objective, cCR12 assessed by independent central
review, continue to mature. 47% (54/116) (95% CI: 37%, 56%) of
evaluable patients have achieved cCR12. An additional 38
participants who are still progressing through to 12 month follow
up have already achieved a clinical complete response.
The
safety profile of
Jemperli
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.
Full
data from the AZUR-1 interim analysis will be presented at the
European Society for Medical Oncology (ESMO) Congress in October
2026.
Jemperli
has received FDA Fast Track and Breakthrough
Therapy designations for this indication. The application was also
granted Priority Review and received a National Priority Voucher,
resulting in an accelerated approval ahead of the PDUFA
date.
The
supplemental Biologics License Application (sBLA) is being reviewed
under Project Orbis, an FDA Oncology Center of Excellence
initiative that enables concurrent review by international health
authorities. Regulatory reviews are ongoing in participating
countries.
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)
4
.
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
5,6
. These biomarkers
are commonly found in colorectal, endometrial and other
gastrointestinal cancers, but can also be present in other solid
tumours
7
.
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
information
8
and
US product
information
9
.
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 Ris Rez targeting B7-H3 and Mo-Rez targeting 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
.
GSK enquiries
Media:
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Foley
+44 (0)
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(London)
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Clements
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603 5003
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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:
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​
References:
1.
Cercek A, Lumish M,
Sinopoli J, et al. PD-1 blockade in mismatch
repair–deficient, locally advanced rectal cancer. N Engl J
Med 2022; 386: 2363-76.
2.
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
3.
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/
4.
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.
5.
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.
6.
Le DT, et al. PD-1
blockade in tumors with mismatch repair deficiency. N Engl J Med.
2015;372(26):2509-2520.
7.
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
8.
JEMPERLI
(dostarlimab) Summary of Product Characteristics. GlaxoSmithKline
(Ireland) Limited. Available at:
https://www.ema.europa.eu/en/medicines/human/EPAR/jemperli.
Accessed October 2026.
9.
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
19, 2026
By:/s/ VICTORIA
WHYTE
--------------------------
Victoria Whyte
Authorised
Signatory for and on
behalf
of GSK plc