Hansoh Pharma/GSK: Ris‑Rez meets PFS endpoint in China phase III ARTEMIS‑011 (relapsed osteosarcoma)

Trial result

Hansoh Pharmaceutical's ARTEMIS‑011 phase III trial in China evaluating risvutatug rezetecan (Ris‑Rez) in patients with osteosarcoma who progressed or relapsed after at least two prior systemic therapies met its primary endpoint of progression‑free survival (PFS), showing statistically significant and clinically meaningful improvements versus chemotherapy.

Efficacy and safety

Consistent benefit was observed across secondary endpoints, including overall survival. The safety profile was consistent with prior findings in this tumour type and no new safety signals were identified. Hansoh intends to use these data for regulatory submission in China.

Development status

Ris‑Rez is a B7‑H3‑targeted antibody‑drug conjugate composed of a fully human anti‑B7‑H3 monoclonal antibody covalently linked to a topoisomerase inhibitor payload. GSK acquired exclusive rights to develop and commercialise Ris‑Rez outside mainland China, Hong Kong, Macau and Taiwan and is advancing EMBOLD Sarcoma‑202, a global phase Ib/II study in previously treated unresectable advanced or metastatic sarcomas, including osteosarcoma. Ris‑Rez has US FDA Breakthrough Therapy Designation in relapsed or refractory osteosarcoma.

Clinical context

Osteosarcoma mainly affects children and young adults and accounts for 20–40% of primary bone cancers. It is a rare disease with a global incidence of approximately 3.4 cases per million people per year. After progression on two prior lines of treatment, therapeutic options are severely limited and no approved therapies exist for that setting.