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 December 2024
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:
16 December 2024, London UK
GSK's B7-H3-targeted antibody-drug conjugate, GSK'227, receives EMA
Priority Medicines (PRIME) Designation in relapsed extensive-stage
small-cell lung cancer
● Regulatory designation based on promising
preliminary clinical data
● PRIME Designation granted to medicines with
potential to address significant unmet medical
needs
● Extensive-stage small-cell lung cancer is
associated with high rates of relapse, few treatment options and
poor prognosis
GSK plc
(LSE/NYSE: GSK) announced today that the European Medicines Agency
(EMA) has granted Priority Medicines (PRIME) Designation for
GSK5764227 (GSK'227), its B7-H3-targeted antibody-drug conjugate
(ADC) being evaluated for the treatment of patients with relapsed
extensive-stage small-cell lung cancer (ES-SCLC). The PRIME
Designation supports the development of medicines with potential to
offer a major therapeutic advantage for patients.[1] This
is the second regulatory designation for GSK'227, following the US
Food and Drug Administration's decision to grant Breakthrough
Therapy Designation in August 2024
[2].
Hesham Abdullah, Senior Vice President, Global Head Oncology,
R&D, GSK, said: "This PRIME Designation is an important step
forward as we seek to accelerate development of GSK'227 in
extensive-stage small-cell lung cancer and other tumour types with
limited treatments. Our investigational B7-H3-targeted ADC is a key
component of our broader ADC programme."
The EMA's PRIME Designation is supported by preliminary clinical
data from the ARTEMIS-001 study. This is an ongoing phase I
open-label, multi-centre trial of more than 200 patients evaluating
the safety, tolerability, and preliminary anti-tumour activity in
locally advanced or metastatic solid tumours, including relapsed
ES-SCLC, conducted by Hansoh Pharma. The efficacy and safety
results from this trial were presented at the 2024 World Conference
on Lung Cancer earlier this year. GSK recently began a global phase
I trial to support a registrational pathway for
GSK'227.
Lung
cancer is a leading cause of cancer-related morbidity and mortality
worldwide.[3] In
Europe, there were an estimated 484,554 new cases and 375,784
deaths from lung cancer in 2022.[4] SCLC
represents 10-15% of all lung cancer cases and is among the
deadliest subtypes.[5],[6] ES-SCLC
constitutes 60% to 85% of all SCLC cases at diagnosis and is
characterised by tumours that have spread beyond the
lungs.[7] Platinum
resistant or refractory patients typically have very poor outcomes,
with median overall survival of less than six months.[8], [9]
Earlier
this year, GSK acquired exclusive worldwide rights (excluding
China's mainland, Hong Kong, Macau, and Taiwan) from Hansoh to
progress clinical development and commercialisation of
GSK'227.[10]
About GSK'227
GSK'227,
also known as HS-20093, is a novel investigational B7-H3-targeted
ADC composed of a fully human anti-B7-H3 monoclonal antibody
covalently linked to a topoisomerase inhibitor (TOPOi) payload.
HS-20093 is being developed by Hansoh Pharma for the treatment of
lung cancer, sarcoma, head and neck cancers and other solid tumours
in multiple phase I, II and III clinical trials in China. GSK's
global phase I trial for GSK'227 began in August 2024.
GSK in oncology
Oncology
is an emerging therapeutic area for GSK where we are committed to
maximising patient survival with a current focus on haematologic
malignancies, gynaecologic cancers, and other solid tumours through
breakthroughs in immuno-oncology and tumour-cell targeting
therapies.
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 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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Simon
Moore / Dan Smith / Sarah Clements
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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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Annabel
Brownrigg-Gleeson
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+44 (0)
7901 101944
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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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Camilla
Campbell
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+44 (0)
7803 050238
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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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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 4855
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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 under Item 3.D
"Risk factors" in GSK's Annual Report on Form 20-F for 2023, and
GSK's Q3 Results for 2024.
Registered
in England & Wales:
No.
3888792
Registered
Office:
79 New
Oxford Street
London
WC1A
1DG
References
[1] European Medicine Agency. PRIME - Priority
Medicines factsheet. Available at: https://www.ema.europa.eu/en/documents/leaflet/prime-paving-way-promising-medicines-patients-factsheet_en.pdf
[2] 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
https://www.gsk.com/en-gb/media/press-releases/gsk-receives-us-fda-breakthrough-therapy-designation/
[3] Leiter A, Veluswamy RR, Wisnivesky JP. The global
burden of lung cancer: current status and
future
trends.
Nat Rev Clin Oncol. 2023;20(9):624-639.
[4] Bray F, Laversanne M, Sung H, et al. Global
cancer statistics 2022: GLOBOCAN estimates of
incidence
and
mortality worldwide for 36 cancers in 185 countries. CA Cancer J
Clin. 2024;74(3):229-263.
[5] Rudin CM, Brambilla E, Faivre-Finn C, et al.
Small-cell lung cancer. Nat Rev Dis Primers.
2021;7(1):3.
[6] Gazdar AF, Bunn PA, Minna JD. Small-cell lung
cancer: what we know, what we need to know and
the
path
forward. Nat Rev Cancer. 2017 Dec;17(12):725-737. Doi:
10.1038/nrc.2017.87. Epub 2017 Oct
27.
Erratum in: Nat Rev Cancer. 2017;17(12):765.
[7] Porte M, Vaudron A, Crequit P, Vaugier L,
Chatellier T, Fronteau C, Raimbourg J, Goronflot T, Bennouna J,
Pons-Tostivint E. A Multicenter Study Assessing the Real-World Use
and Effectiveness of First-Line Chemotherapy Plus Immunotherapy in
Advanced Small-Cell Lung Cancer (SCLC) Patients. Clin Lung Cancer. 2024 Mar;25(2):e101-e111.e2.
doi: 10.1016/j.cllc.2023.11.009. Epub 2023 Nov 23. PMID:
38072729.
[8] Trigo J, Subbiah V, Besse B, Moreno V, López
R, Sala MA, Peters S, Ponce S, Fernández C, Alfaro V,
Gómez J, Kahatt C, Zeaiter A, Zaman K, Boni V, Arrondeau J,
Martínez M, Delord JP, Awada A, Kristeleit R, Olmedo ME,
Wannesson L, Valdivia J, Rubio MJ, Anton A, Sarantopoulos J, Chawla
SP, Mosquera-Martinez J, D'Arcangelo M, Santoro A, Villalobos VM,
Sands J, Paz-Ares L. Lurbinectedin as second-line treatment for
patients with small-cell lung cancer: a single-arm, open-label,
phase 2 basket trial. Lancet Oncol. 2020 May;21(5):645-654. doi:
10.1016/S1470-2045(20)30068-1. Epub 2020 Mar 27. Erratum in: Lancet
Oncol. 2020 Dec;21(12):e553. doi: 10.1016/S1470-2045(20)30676-8.
PMID: 32224306.
[9]Topotecan USP. Available
at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022453s002lbl.pdf.
Accessed 13 Nov 2024
[10] GSK. GSK enters exclusive license agreement with
Hansoh for HS-2009. Available at: https://www.gsk.com/en-gb/media/press-releases/gsk-enters-exclusive-license-agreement-with-hansoh-for-hs-20093/
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: December
16, 2024
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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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GSK (PK) (USOTC:GLAXF)
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