Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]
20 August 2024 - 8:30PM
Edgar (US Regulatory)
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 August 2024
Commission
File Number 001-15170
GSK plc
(Translation
of registrant's name into English)
980 Great West Road, Brentford, Middlesex, TW8 9GS
(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: 20 August 2024, London UK
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
●
Regulatory
designation based on promising early clinical evidence observed
with GSK5764227 in this tumour type
●
Breakthrough
Therapy Designation aims to expedite development and review of
drugs with potential to show improvement over available therapies
for serious conditions
●
Patients
with this aggressive form of lung cancer who experience disease
progression on or after chemotherapy have limited treatment options
that typically result in poor outcomes
GSK plc (LSE/NYSE: GSK) announced
today that the US Food and Drug Administration (FDA) has granted
Breakthrough Therapy Designation for GSK5764227 (GSK'227), the
Company's investigational B7-H3-targeted antibody drug conjugate
(ADC) being evaluated for the treatment of patients with
extensive-stage small-cell lung cancer (ES-SCLC) with disease
progression on or after platinum-based chemotherapy (relapsed or
refractory). 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]
Hesham Abdullah, Senior Vice President, Global Head Oncology,
R&D, GSK, said: “Extensive-stage
small-cell lung cancer is aggressive with poor prognosis and
significant need for new treatments. Today's Breakthrough Therapy
Designation supports our ambition to accelerate GSK'227 for these
patients as part of our broader ADC programme focused on developing
new treatment options with transformational and first-to-market
potential.”
Lung cancer is one of the most common cancers worldwide. In the US,
approximately 15% of all lung cancers are small-cell. Of patients
with small-cell lung cancer, 70% have extensive-stage disease
meaning the cancer has spread throughout one or both lungs and/or
to other parts of the body
[2].
ES-SCLC is an aggressive and difficult-to-treat cancer with limited
treatment options. The 5-year survival rate is approximately
3%2.
Most patients with ES-SCLC relapse after initial treatment and the
median overall survival with current standard-of-care treatments
for relapsed ES-SCLC is 5-6 months[3] [4].
Earlier this 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[5].
FDA's Breakthrough Therapy Designation is supported by data from
the ongoing ARTEMIS-001 Phase 1 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 or refractory ES-SCLC, conducted by Hansoh Pharma. Results
from this trial will be presented at the 2024 World Conference on
Lung Cancer taking place from 7-10 September in San Diego,
California, USA. GSK plans to begin global phase 1/2 trials in 2H
2024 to support a registrational pathway for
GSK'227.
About GSK5764227
GSK5764227, also known as HS-20093, is
a novel investigational B7-H3-targeted antibody-drug conjugate
composed of a fully humanised anti-B7-H3 monoclonal antibody
covalently linked to 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 and II clinical trials in China, with GSK's global Phase I
trials for GSK5764227 set to begin in 2H 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.
GSK enquiries
|
|
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Media:
|
Tim
Foley
|
+44 (0)
20 8047 5502
|
(London)
|
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Sarah
Clements
|
+44 (0)
20 8047 5502
|
(London)
|
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Kathleen
Quinn
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+1 202
603 5003
|
(Washington
DC)
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Lyndsay
Meyer
|
+1 202
302 4595
|
(Washington
DC)
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|
|
|
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Investor
Relations:
|
Nick
Stone
|
+44 (0)
7717 618834
|
(London)
|
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James
Dodwell
|
+44 (0)
20 8047 2406
|
(London)
|
|
Mick
Readey
|
+44 (0)
7990 339653
|
(London)
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|
Josh
Williams
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+44 (0)
7385 415719
|
(London)
|
|
Camilla
Campbell
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+44 (0)
7803 050238
|
(London)
|
|
Steph
Mountifield
|
+44 (0)
7796 707505
|
(London)
|
|
Jeff
McLaughlin
|
+1 215
751 7002
|
(Philadelphia)
|
|
Frannie
DeFranco
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+1 215
751 4855
|
(Philadelphia)
|
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 Q2 Results for 2024.
Registered in England & Wales:
No.
3888792
Registered Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
References
1https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy
[2] SEER
Explorer Surveillance Research Program, National Cancer Institute,
accessed 23 January 2024.
[3] Topotecan
USPI accessed 11 March 2024
[4] Trigo
et al, Lancet Oncology, 2020; 21: 645-654.
[5] 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: August
20, 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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