GSK 6-K
GSK plc (GSK)
6-K
2026-09-14
For: 2026-09-14
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September 14, 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 September 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 September 2026, London UK
Ris-Rez reduced risk of death by 54% versus topotecan in patients
with relapsed small cell lung cancer in China
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Patients
receiving Ris-Rez lived a median of 18.5 months versus 10.3 months
with comparator
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Longer
survival achieved with fewer severe treatment-related side effects
versus comparator
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GSK
is developing Ris-Rez in small cell lung cancer and other solid
tumours outside China
GSK plc (LSE/NYSE: GSK) licensor Hansoh Pharmaceutical Group Co.,
Ltd., today announced positive overall survival (OS) data from
ARTEMIS-008, its pivotal phase III trial in China evaluating the
B7-H3-targeted antibody-drug conjugate (ADC) risvutatug rezetecan
(Ris-Rez) versus topotecan in patients with relapsed small cell
lung cancer (SCLC) whose disease progressed following
platinum-based first-line therapy. These results, first announced
in July, are the first Phase III data to demonstrate an OS benefit
for a B7-H3 ADC in any tumour type.
In the trial, Ris-Rez reduced the risk of death by 54% compared
with topotecan, a commonly used treatment option following
progression on first-line therapy, meeting the trial's primary
endpoint after a median follow-up of 12.2 months (HR 0.46; 95% CI:
0.35-0.62, p<0.0001). Patients receiving Ris-Rez lived a median
of 18.5 months (n=230) compared with 10.3 months for those
receiving topotecan (n=231). These results were presented in a
Presidential Symposium session at the 2026 World Conference on Lung
Cancer (WCLC) in Seoul, South Korea.
Hesham Abdullah, Senior Vice President, Global Head of Oncology,
R&D, GSK said, "These
results add to the growing body of evidence for Ris-Rez and mark an
important step forward for our lung cancer portfolio. The
significant improvement in survival observed in this study,
together with an encouraging safety profile, provide further
momentum for GSK’s global development of Ris-Rez across
later-line and earlier treatment settings for small cell lung
cancer."
The OS benefit observed was supported by improvements across key
secondary efficacy endpoints. Median progression-free survival as
assessed by an independent review committee (IRC) was 7.2 months
versus 3.0 months (HR 0.33; 95% CI: 0.25-0.42); IRC-assessed
objective response rate was 58.3% versus 12.6%; and IRC-assessed
disease control rate was 90.4% versus 60.2% for Ris-Rez and
topotecan, respectively.
Patients receiving Ris-Rez experienced fewer severe
treatment-related side effects (TRAEs) than those receiving
topotecan, with grade 3 or higher TRAEs occurring in 60.9% versus
78.2% of patients, respectively. The most common grade 3 or higher
TRAEs with Ris-Rez were decreased neutrophils, decreased white
blood cells, anaemia, decreased lymphocytes and decreased
platelets. These haematologic TRAEs are considered manageable and
consistent with the known side effects in this class of
medicines.
Jie Wang, M.D., Chair, Medical Oncology Department, National Cancer
Center, Chinese Academy of Medical Sciences and Principal
Investigator of the ARTEMIS-008 trial,
said, “Relapsed
small cell lung cancer remains one of the most challenging cancers
to treat, with few therapies delivering meaningful improvements in
survival once the disease returns. In ARTEMIS-008, patients
receiving Ris-Rez lived substantially longer while experiencing
lower rates of severe treatment-related side effects. These
findings suggest Ris-Rez could represent an important advance for
patients.”
GSK holds exclusive rights to develop and commercialise Ris-Rez
outside mainland China, Hong Kong, Macau and Taiwan, and is
advancing a broad global clinical development programme across lung
cancer, prostate cancer and other solid tumours, including the
phase III EMBOLD SCLC-301 trial in relapsed extensive-stage SCLC,
with pivotal data expected next year.
About ARTEMIS-008
ARTEMIS-008 is Hansoh’s multicentre, randomised, open-label,
active-controlled phase III trial evaluating Ris-Rez versus
topotecan in patients in China with limited- or extensive-stage
SCLC whose disease progressed on or after first-line platinum-based
therapy. Patients were randomised 1:1 to receive Ris-Rez 8.0 mg/kg
every three weeks or topotecan 1.2 mg/m² on days 1–5 of
each 21-day cycle. The primary endpoint is statistically
significant and clinically meaningful improvement in overall
survival. Secondary endpoints include progression-free survival,
objective response rate, disease control rate, duration of response
and safety.
About risvutatug rezetecan
Ris-Rez is a novel investigational antibody-drug conjugate
targeting the B7-H3 protein, which is highly expressed in more than
10 solid tumour types, supporting GSK’s ambition to develop
it across more than 40 indications by 2040. More than 1,000
patients have received Ris-Rez as part of GSK’s global EMBOLD
clinical trial programme, which includes a phase III trial in
late-line extensive-stage small cell lung cancer (ES-SCLC), with
additional upcoming phase III trials planned in early-line SCLC and
metastatic prostate cancers. Ris-Rez has received several global
regulatory designations to date, such as orphan drug designations
in the US, Japan and the EU for SCLC, and Breakthrough Therapy
Designation in the US and Priority Medicines (PRIME) Designation
from the EMA for relapsed or refractory ES-SCLC, among
others.1, 2, 3,
4,5
About small cell lung cancer
Small cell lung cancer (SCLC) is associated with rapid progression
and accounts for approximately 10-15% of all lung cancer diagnoses
worldwide.6 SCLC
is characterised by early metastatic spread, frequent relapse and
poor prognosis.6 Approximately
70% of patients with SCLC are diagnosed with extensive-stage
disease (ES-SCLC), meaning the cancer has spread throughout one or
both lungs and/or to other parts of the body.6,7 Median
overall survival for patients with ES-SCLC treated with current
standard-of-care therapies is approximately 12 to 13
months.7 Despite
advances in treatment, outcomes for patients with ES-SCLC remain
poor and risk of disease progression or recurrence remains high,
underscoring the need for new therapies that can improve outcomes
for patients facing this aggressive cancer.
GSK in oncology
GSK’s 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 (ADCs) Ris-Rez
targeting B7-H3 and Mo-Rez targeting B7-H4, and velzatinib, a
highly selective KIT tyrosine kinase inhibitor.
GSK’s focus in lung cancer is to develop medicines that can
deliver durable responses, overcoming resistance and reducing
treatment burden across small cell and non-small cell lung cancers.
GSK’s lung cancer portfolio is built on validated targets and
modalities where we have growing expertise, including targeted
small molecules and ADCs. This approach allows us to match the
right therapeutic modality to the right target, tumour type and
patient need – with the bold ambition to launch multiple new
options in lung cancer over the next five years.
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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Sarah Clements
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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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Kathleen Quinn
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+1 202 603 5003
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(Washington DC)
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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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Constantin Fest
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+44 (0) 7831 826525
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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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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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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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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.
GSK.
GSK receives US FDA Breakthrough Therapy Designation for its
B7-H3-targeted antibody-drug conjugate in relapsed or refractory
extensive-stage small-cell lung cancer. Available at:
https://www.gsk.com/en-gb/media/press-releases/gsk-receives-us-fda-breakthrough-therapy-designation/.
2.
GSK.
GSK’s B7-H3-targeted antibody-drug conjugate, risvutatug
rezetecan, granted Orphan Drug Designation for small-cell lung
cancer in Japan. Available at:
https://www.gsk.com/en-gb/media/press-releases/gsk-s-b7-h3-targeted-antibody-drug-conjugate-risvutatug-rezetecan-granted-orphan-drug-designation-for-small-cell-lung-cancer-in-japan/.
3.
GSK.
GSK’s B7-H3-targeted antibody-drug conjugate, GSK’227,
receives EMA Priority Medicines (PRIME) Designation in relapsed
extensive-stage small-cell lung cancer. Available at:
https://www.gsk.com/en-gb/media/press-releases/b7-h3-targeted-antibody-drug-conjugate-receives-ema-priority-medicines-designation-in-relapsed-extensive-stage-small-cell-lung-cancer/.
4.
GSK’s
B7-H3-targeted antibody-drug conjugate, GSK’227, receives
Orphan Drug Designation in the EU. Available at:
https://www.gsk.com/en-gb/media/press-releases/gsk-s-b7-h3-targeted-antibody-drug-conjugate-gsk-227-receives-orphan-drug-designation-in-the-eu
5.
GSK. GSK’s B7-H3-targeted antibody-drug
conjugate, GSK’227, receives US FDA Breakthrough Therapy
Designation in late-line relapsed or refractory osteosarcoma.
Available at: https://www.gsk.com/en-gb/media/press-releases/gsk-b7-h3-targeted-antibody-drug-conjugate-gsk227-receives-us-fda-breakthrough-therapy-designation-in-late-line-relapsed-or-refractory-osteosarcoma/.
6.
Kim S, Park H, Chiang A. Small Cell Lung Cancer: A
Review. JAMA.
2025.
7.
Saida Y, Watanabe S, Kikuchi
T. Extensive-Stage Small-Cell
Lung Cancer: Current Landscape and Future
Prospects. Onco Targets Ther.
2023.
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: September
14, 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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