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 March 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: 23 March 2026,
London UK
GSK's B7-H3-targeted antibody-drug conjugate, risvutatug rezetecan,
granted Orphan Drug Designation for small-cell lung cancer
in Japan
● Designation supported by early clinical data
showing durable responses in certain types of small-cell lung
cancer (SCLC)
● Extensive-stage
SCLC is associated with high rates of relapse, few treatment
options and poor prognosis
● Sixth
global regulatory designation for risvutatug rezetecan supporting
GSK's investigational ADC with transformational potential in solid
tumours
GSK plc (LSE/NYSE: GSK) today announced that risvutatug rezetecan
(or Ris-Rez, for short), a
B7-H3-targeted antibody-drug conjugate (ADC), has
received Orphan Drug Designation (ODD) from Japan's Ministry of
Health, Labour and Welfare for the treatment of small-cell lung
cancer (SCLC). The ODD was supported by preliminary clinical data
showing durable responses in patients with extensive-stage SCLC
(ES-SCLC) who were treated with Ris-Rez in
the phase I ARTEMIS-001 clinical trial.[1] This
is the sixth regulatory designation for Ris-Rez, which
is being
developed in a range of solid tumours, including lung, prostate and
colorectal cancers.
Lung cancer is the second most common cancer in Japan, and SCLC
makes up 10-15% of cases.
[2],[3] Of
patients with SCLC, 70% have ES-SCLC, meaning the cancer has spread
throughout one or both lungs and/or to other parts of the
body.[4] ES-SCLC
is an aggressive and difficult-to-treat cancer with limited
treatment options and poor long-term survival. Most patients with
ES-SCLC relapse after initial treatment and the median overall
survival with standard-of-care for these patients is approximately
8 months.[5]
About Ris-Rez
Ris-Rez is a novel investigational B7-H3-targeted antibody-drug
conjugate 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. GSK's global
phase III trial (NCT07099898) for Ris-Rez in relapsed ES-SCLC began
in August 2025.
Regulatory designations received for Ris-Rez to date
include ODDs
from the US
Food and Drug Administration (FDA) 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.[6],[7],[8]
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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Dan
Smith
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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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Lyndsay
Meyer
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+1 202
302 4595
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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.
Registered in England & Wales:
No.
3888792
Registered Office:
79
New Oxford Street
London
WC1A
1DG
[1] Wang
J, et al. Presented at IASLC WCLC 2024.
[2] GLOBOCAN
2022 https://gco.iarc.who.int/media/globocan/factsheets/populations/392-japan-fact-sheet.pdf Accessed
9 March 2026
[3] Japan
Lung Cancer Society. Lung Cancer Clinical Practice Guidelines 2025
Edition. Available at https://www.haigan.gr.jp/publication/guideline/examination/2025/
[4] SEER
Explorer Surveillance Research Program, National Cancer Institute,
accessed 27 October 2025.
[5] 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
[6] 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/.
[7] 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/.
[8] 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: March
23, 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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