REG - GSK PLC - B7-H3 ADC US FDA Breakthrough Therapy Designation

GSKAnnouncement

20/08/2024 07:00

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RNS Number : 0175B  GSK PLC  20 August 2024

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  (#_edn1)

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 
(#_edn2) . 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  (#_edn3)  4  (#_edn4) .

 

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  (#_edn5) . 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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References

 

1https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy

 2  (#_ednref2) SEER Explorer Surveillance Research Program, National Cancer
Institute, accessed 23 January 2024.

 3  (#_ednref3) Topotecan USPI accessed 11 March 2024

 4  (#_ednref4) Trigo et al, Lancet Oncology, 2020; 21: 645-654.

 5  (#_ednref5)
https://www.gsk.com/en-gb/media/press-releases/gsk-enters-exclusive-license-agreement-with-hansoh-for-hs-20093/

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