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 January 2025
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: 7 January 2025, London UK
GSK's B7-H3-targeted antibody-drug conjugate, GSK'227, receives US
FDA Breakthrough Therapy Designation in late-line relapsed or
refractory osteosarcoma
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Regulatory
designation based on promising early data in this rare bone
cancer
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Breakthrough
Therapy Designation granted to drugs with potential to show
improvement for serious conditions
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There
are no FDA-approved treatments for patients with osteosarcoma who
have progressed on two prior lines of therapy
GSK plc (LSE/NYSE: GSK) announced today that the US Food and Drug
Administration (FDA) has granted Breakthrough Therapy Designation
for GSK5764227 (GSK'227), its B7-H3-targeted antibody-drug
conjugate (ADC) being evaluated for the treatment of adult patients
with relapsed or refractory osteosarcoma (bone cancer) who have
progressed on at least two prior lines of therapy. The Breakthrough
Therapy Designation aims to expedite the development and review of
drugs with the potential to treat a serious condition and where
preliminary clinical evidence may indicate substantial improvement
over currently available therapy.[1] This
is the third regulatory designation for GSK'227, following the
European Medicines Agency's decision to grant Priority
Medicines (PRIME) designation and the FDA's decision to grant
Breakthrough Therapy Designation for relapsed
or refractory extensive-stage
small-cell lung cancer in August 2024 and December 2024,
respectively.
[2],[3]
Hesham Abdullah, Senior Vice President, Global Head Oncology,
R&D, GSK, said: "This
latest regulatory designation for GSK'227 exemplifies the potential
of our targeted ADC in patients with difficult to treat cancers.
For patients with relapsed or refractory osteosarcoma, there is an
urgent unmet medical need with no approved treatment options once
the cancer returns a second time, and chemotherapy provides limited
benefit in this setting."
The US FDA's Breakthrough Therapy Designation is supported by data
from the ARTEMIS-002 study. This is a phase II, open-label,
randomised, multi-centre, clinical trial evaluating the efficacy
and safety of GSK'227 in patients with relapsed or refractory
osteosarcoma and other unresectable bone and soft tissue sarcomas,
conducted by Hansoh Pharma. More than 60 patients were enrolled,
including 42 patients with osteosarcoma. Results from ARTEMIS-002
were presented at the 2024 American Society of Clinical Oncology
Annual Meeting.[4] Last
year, GSK acquired exclusive worldwide rights (excluding China's
mainland, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to
progress clinical development and commercialisation of
GSK'227. GSK
recently began a global phase I trial (NCT06551142) as
a part of the development plan to support a registrational pathway
for GSK'227.
Osteosarcoma mainly affects children and young adults and is the
most common primary bone cancer, accounting for 20-40% of all bone
cancers.[5] It
is a rare disease with an annual incidence of 3.3 patients per
million in the US, representing less than 1% of all new cancer
diagnoses.[6],[7] Approximately
20-30% of patients who present with localised (non-metastatic)
osteosarcoma and 80% of those who present with metastatic
osteosarcoma experience relapsed or refractory
disease.[8] Following
first-line chemotherapy, treatment options for patients with
relapsed or refractory osteosarcoma are severely limited, with no
clear standard of care available.[9] After
patients progress on two prior lines of treatment, options become
even more limited, with no approved therapies.
About GSK'227
GSK'227, also known as HS-20093, 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. 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] US
Food and Drug Administration. Breakthrough Therapy. Available
at: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy
[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. Available
at: https://www.gsk.com/en-gb/media/press-releases/gsk-receives-us-fda-breakthrough-therapy-designation/.
[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] Lu
Xie et al., ARTEMIS-002: Phase 2 study of HS-20093 in patients with
relapsed or refractory osteosarcoma JCO 42,
11507-11507(2024).
DOI:10.1200/JCO.2024.42.16_suppl.11507
[5] Valery
PC, Laversanne M, Bray F. Bone cancer incidence by morphological
subtype: a global assessment. Cancer Causes Control.
2015;26(8):1127-39.
[6] Cole
S, Gianferante DM, Zhu B, et al. Osteosarcoma:
A surveillance, epidemiology, and end results program-based
analysis from 1975 to 2017. Cancer.
2022;128(11):2107-18.
[7] Mirabello
L, Troisi RJ, Savage SA. International osteosarcoma incidence
patterns in children and adolescents, middle ages and elderly
persons. Int J Cancer. 2009;125(1):229-34.
[8] Durfee
RA, Mohammed M, Luu HH. Review of Osteosarcoma and Current
Management. Rheumatol Ther. 2016 Dec;3(2):221-243. doi:
10.1007/s40744-016-0046-y. Epub 2016 Oct 19. PMID: 27761754; PMCID:
PMC5127970.
[9] National
Comprehensive Cancer Network (NCCN). NCCN clinical practice
guidelines in oncology (NCCN Guidelines): bone cancer. August 20,
2024. Version 1.2025. Accessed 24 October 2024. https://www.nccn.org/professionals/physician_gls/pdf/bone.pdf.
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: January
07, 2025
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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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