GLAXF 6-K
GSK plc (GSK)
6-K
2026-07-10
For: 2026-07-10
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Added on
July 10, 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: 10 July 2026, London UK
GSK's licensor Hansoh Pharma announces positive phase III results
for Ris-Rez in China patient population
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ARTEMIS-008,
a phase III study conducted for China, met its primary endpoint of
overall survival in advanced or relapsed small-cell lung
cancer
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First
positive phase III overall survival data for a B7-H3-targeted ADC
in any tumour type
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GSK
is advancing risvutatug rezetecan outside China across multiple
tumour types, including lung cancer, prostate cancer and other
solid tumours
GSK plc (LSE/NYSE: GSK) licensor Hansoh Pharmaceutical Group Co.,
Ltd. today announced that ARTEMIS-008, its pivotal phase III trial
evaluating risvutatug rezetecan (Ris-Rez) in patients with advanced
or relapsed small-cell lung cancer (SCLC), met its primary endpoint
of overall survival (OS). In the trial, conducted in patients in
China, Ris-Rez demonstrated statistically significant and
clinically meaningful improvements in OS compared with the standard
of care, topotecan. Consistent benefit was also observed across key
secondary endpoints, including progression-free survival. These
data will be used by Hansoh Pharma for regulatory
submission in
China.
These are the first positive phase III overall survival data
reported for a B7-H3-targeted antibody-drug conjugate (ADC) in any
tumour type. The
safety profile is consistent with prior Ris-Rez findings, and no
new safety signals were identified.
GSK holds exclusive global rights to develop Ris-Rez outside
mainland China, Hong Kong, Macau and Taiwan. GSK's broad clinical
development programme includes studies in lung cancer, prostate
cancer and other solid tumours, including the global phase III
EMBOLD SCLC-301 trial in relapsed extensive-stage small-cell lung
cancer (ES-SCLC) with pivotal data expected next year.
Hesham Abdullah, Senior Vice President, Global Head Oncology,
R&D, GSK said: "These
results are an important milestone as the first positive phase III
overall survival data for a B7-H3-targeted ADC in any tumour type.
Together, with other data generated to date, they further support
the potential of B7-H3 as a promising target across lung cancer and
other solid tumours and reinforce our continued development of
Ris-Rez to improve standard of care in areas of high unmet
need."
Most patients with ES-SCLC relapse after initial therapy and have
limited treatment options, poor prognosis and significant treatment
burden.1 B7-H3
is highly expressed in SCLC tumours2,3 and
the positive results from ARTEMIS-008 add to the growing body of
evidence supporting the encouraging clinical activity and
manageable safety profile of Ris-Rez in patients with
ES-SCLC.
About risvutatug
rezetecan
Ris-Rez is a novel investigational B7-H3-targeted ADC composed of a
fully human anti-B7-H3 monoclonal antibody covalently linked to a
topoisomerase inhibitor payload. GSK acquired exclusive worldwide
rights (excluding China's mainland, Hong Kong, Macau, and Taiwan)
from Hansoh Pharma to progress clinical development and
commercialisation of Ris-Rez.
Regulatory designations received for Ris-Rez to date include orphan
drug designations from the US Food and Drug Administration (FDA)
and Japan's Ministry of Health, Labour and Welfare in SCLC and the
European Medicines Agency (EMA) in a category of cancer that
includes SCLC, called pulmonary neuroendocrine carcinoma; Priority
Medicines (PRIME) Designation from the EMA for relapsed or
refractory ES-SCLC; and Breakthrough Therapy Designations for
relapsed or refractory ES-SCLC and relapsed or refractory
osteosarcoma from the US FDA.4,5,6,7,8,9,10
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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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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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. G. Mountzios, et al. Tarlatamab in small-cell lung cancer after
platinum-based chemotherapy. N Engl J Med, 393 (2025), pp. 349-361.
DOI: 10.1056/NEJMoa2502099.
2. A.A. Getu, A. Tigabu, M. Zhou, J. Lu, Ø. Fodstad, M. Tan.
New frontiers in immune checkpoint B7-H3 (CD276) research and drug
development. Mol. Cancer, 22 (2023),
p. 43, 10.1186/s12943-023-01751-9.
3. M. Altan, V. Pelekanou, K.A. Schalper, M. Toki, P. Gaule, K.
Syrigos, R.S. Herbst, D.L. Rimm. B7-H3 Expression in NSCLC and Its
Association with B7-H4, PD-L1 and Tumor-Infiltrating Lymphocytes.
Clin. Cancer Res., 23 (2017), pp. 5202-5209,
10.1158/1078-0432.Ccr-16-3107.
4. 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/.
5. 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/.
6. 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/.
7. GSK. 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/.
8. 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/.
9. 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/.
10.
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/.
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
10, 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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