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
· Regulatory designation based on promising early data in this
rare bone cancer
· Breakthrough Therapy Designation granted to drugs with
potential to show improvement for serious conditions
· 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.
GSK
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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.
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