African Pharmaceutical Review.

African Pharmaceutical Review.

GSK’s investigational antibody-drug conjugate achieves breakthrough therapy designation

GSK’s investigational antibody-drug conjugate achieves breakthrough therapy designation

GSK


GSK has revealed that its B7-H3-targeted antibody-drug conjugate (ADC), GSK5764227 (GSK'227), has received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA).

This ADC is being tested for the treatment of adult patients with relapsed or refractory osteosarcoma (bone cancer) who have advanced on at least two previous lines of therapy.

Patients with relapsed or refractory osteosarcoma have very few therapeutic choices after first-line chemotherapy, and there is no established standard of care.[9] With no approved medicines, patients' options become even more constrained if they make progress on two previous lines of treatment.

The goal of the Breakthrough Therapy Designation is to accelerate the development and evaluation of medications that have the potential to treat critical illnesses and where early clinical data suggests a significant improvement over existing treatment.

About the therapy

The new investigational B7-H3-targeted antibody-drug combination GSK'227, also called HS-20093, is made up of a topoisomerase inhibitor payload covalently bound to a completely human anti-B7-H3 monoclonal antibody.

In China, Hansoh Pharma is conducting many phase I, II, and III clinical trials to develop HS-20093 for the treatment of solid tumors, including head and neck malignancies, sarcoma, and lung cancer. In August 2024, GSK launched its global phase I study for GSK'227.

GSK purchased the exclusive global rights from Hansoh Pharma last year to forward the clinical development and commercialization of GSK'227, with the exception of the Chinese mainland, Hong Kong, Macau, and Taiwan. In order to promote a registrational approach for GSK'227, GSK recently launched a global phase I trial (NCT06551142).


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About the trial

Data from Hansoh Pharma's ARTEMIS-002 study, a phase II, open-label, randomised, multi-centre clinical trial assessing the safety and effectiveness of GSK'227 in patients with relapsed or refractory osteosarcoma and other unresectable bone and soft tissue sarcomas, provided support for the US FDA's Breakthrough Therapy Designation. Of the 60 patients enrolled, 42 had osteosarcoma.

Results showed that GSK'227exhibited ‘promising’ tumor activity with acceptable toxicity in patients previously treated for relapsing/refractory osteosarcoma.

What was 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," stated Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK.

Conclusion

After being granted Priority Medicines (PRIME) designation by the European Medicines Agency and Breakthrough Therapy Designation for relapsed or refractory extensive-stage small-cell lung cancer by the FDA in August 2024 and December 2024, respectively, GSK'227 now has three regulatory designations.


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APR Team

African Pharmaceutical Review team dedicated to providing the latest news, insights and developments from the pharma, biotech and medtech industries.