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.
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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 Q2 Results
for 2024.
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