GSK has gained US Food and Drug Administration (FDA) breakthrough therapy designation (BTD) for its B7-H3-targeted antibody-drug conjugate (ADC), GSK’227, to treat adults with relapsed or refractory osteosarcoma who have progressed on a minimum of two previous lines of therapy.
This marks the third regulatory milestone for the therapy.
The BTD is backed by data from the randomised, multi-centre Phase II ARTEMIS-002 trial assessing the safety and efficacy of the therapy in subjects with this condition and other unresectable bone and soft tissue sarcomas.
Conducted by China-based pharmaceutical company Hansoh Pharma, the trial enrolled more than 60 subjects, along with 42 osteosarcoma subjects.
GSK oncology research and development global head and senior vice-president Hesham Abdullah stated:聽鈥淭his latest regulatory designation for GSK鈥�227 exemplifies the potential of our targeted ADC in patients with difficult to treat cancers.
鈥淔or patients with relapsed or refractory osteosarcoma, there is an urgent unmet medical need with no approved treatment options once the cancer returns, and chemotherapy provides limited benefit in this setting.鈥�
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By GlobalDataGSK acquired exclusive global rights, excluding mainland China Macau, Taiwan and Hong Kong, to the therapy from Hansoh Pharma in 2024.
The acquisition allows GSK to clinically develop and commercialise GSK鈥�227 further globally clinically. The company has recently initiated a global Phase I trial as part of the development plan to support the therapy鈥檚 registrational pathway.
Predominantly affecting children and young adults, osteosarcoma is the most widespread primary bone cancer.
Also known as HS-20093, GSK’227 is a fully human anti-B7-H3 monoclonal antibody linked covalently to a topoisomerase inhibitor payload.
In November 2024, GSK received Japan’s Ministry of Health, Labour and Welfare鈥檚 approval to extend the indication of its respiratory syncytial virus (RSV) vaccine, Arexvy, to include individuals aged 50 to 59 at increased risk.
