GSK plc licensor Hansoh Pharmaceutical Group has announced that ARTEMIS-011, its pivotal phase 3 trial evaluating risvutatug rezetecan (Ris-Rez) in patients with osteosarcoma who have progressed or relapsed after receiving at least 2 prior lines of systemic therapy, met its primary endpoint of Progression-Free Survival (PFS).

In the trial conducted in patients in China, Ris-Rez, a B7-H3-targeted Antibody Drug Conjugate (ADC), demonstrated statistically significant and clinically meaningful improvements in PFS compared with chemotherapy. Consistent benefit was also observed across secondary endpoints, including overall survival. The safety profile of ARTEMIS-011 is consistent with prior findings in this tumor type, and no new safety signals were identified. These data will be used by Hansoh Pharma for regulatory submission in China.

GSK is advancing EMBOLD Sarcoma-202, a global phase 1b/2 trial of Ris-Rez in previously treated unresectable advanced or metastatic sarcomas, including osteosarcoma. The study is part of GSK’s broader clinical development program across multiple solid tumors, including lung and prostate cancers, under its exclusive global rights to develop Ris-Rez outside mainland China, Hong Kong, Macau and Taiwan. Ris-Rez has US Food and Drug Administration (FDA) Breakthrough Therapy Designation (BTD) in relapsed or refractory osteosarcoma.

The results from Hansoh follow recently reported pivotal data in advanced or relapsed Small Cell Lung Cancer (SCLC), making Ris-Rez the only B7-H3-targeted ADC to deliver positive phase 3 outcomes across multiple tumor types.

Hesham Abdullah, Senior Vice President (SVP), Global Head Oncology, Research and Development (R&D), GSK, said, "Building on recent pivotal data in Small Cell Lung Cancer, these results strengthen our confidence in the broad potential of Ris-Rez and validate B7-H3 as a promising target across multiple tumor types."