GSK partner Hansoh Pharmaceutical's bone cancer drug meets primary endpoint in second Phase III trial in China

GSK partner Hansoh Pharmaceutical announced that its experimental antibody-drug conjugate, risvutatug rezetecan (ris-rez), met the primary endpoint of progression-free survival in the Phase III ARTEMIS-011 trial for Chinese patients with relapsed osteosarcoma. This success follows a prior Phase III win in small cell lung cancer, bolstering GSK's oncology portfolio. GSK licensed the drug's global rights outside Greater China in 2023 for up to $1.5 billion and is conducting global Phase Ib/II trials.

ARTEMIS-011 osteosarcoma trial results

• ▪The ARTEMIS-011 trial evaluated risvutatug rezetecan in osteosarcoma patients who progressed or relapsed after receiving at least two prior lines of systemic therapy.
• ▪Hansoh Pharmaceutical plans to initiate communications to prepare for a biologics license application for risvutatug rezetecan in China in the near term.
• ▪The Phase III ARTEMIS-011 trial of risvutatug rezetecan met its primary endpoint of progression-free survival in Chinese patients with relapsed osteosarcoma.
• ▪In the ARTEMIS-011 trial, risvutatug rezetecan demonstrated statistically significant and clinically meaningful improvements in progression-free survival compared with chemotherapy.

Ris-Rez multi-tumour clinical development

• ▪Risvutatug rezetecan previously demonstrated positive Phase III results in the ARTEMIS-008 trial for patients with advanced or relapsed small cell lung cancer.
• ▪GSK is conducting the global Phase Ib/II EMBOLD Sarcoma-202 study evaluating risvutatug rezetecan in pretreated, unresectable advanced or metastatic sarcomas.
• ▪GSK is advancing clinical development of risvutatug rezetecan outside China across multiple solid tumours, including lung, prostate, and other solid cancers.

GSK Hansoh licensing agreement

• ▪GSK licensed exclusive worldwide rights to develop and commercialise risvutatug rezetecan outside mainland China, Hong Kong, Macau, and Taiwan from Hansoh Pharmaceutical in 2023.
• ▪The licensing agreement between GSK and Hansoh Pharmaceutical for risvutatug rezetecan was valued at up to $1.5 billion.

Osteosarcoma treatment options

• ▪Osteosarcoma is a rare bone cancer with a global incidence of approximately 3.4 cases per million people per year, primarily affecting children and young adults.
• ▪Following first-line chemotherapy and surgery, treatment options for patients with relapsed osteosarcoma are severely limited, with no approved therapies after progressing on two prior lines.

FDA Breakthrough Therapy Designation

• ▪Risvutatug rezetecan has received Breakthrough Therapy Designation from the US Food and Drug Administration for relapsed or refractory osteosarcoma.

B7-H3 targeted antibody-drug conjugate

• ▪Risvutatug rezetecan is an antibody-drug conjugate composed of a fully human anti-B7-H3 monoclonal antibody covalently linked to a topoisomerase inhibitor payload.
• ▪Risvutatug rezetecan is the only B7-H3-targeted antibody-drug conjugate to deliver positive Phase III outcomes across multiple distinct tumour types.

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