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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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:
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WC1A 1DG
[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.