GSK reports positive phase III data for Ris-Rez in relapsed osteosarcoma

GSK and licensing partner Hansoh Pharmaceutical Group have announced results from the ARTEMIS-011 phase III study, which evaluated the antibody-drug conjugate risvutatug rezetecan (Ris-Rez) in patients with relapsed or refractory osteosarcoma. The data showed that Ris-Rez significantly improved progression-free survival (PFS) compared to physician-chosen chemotherapy.

In the study, patients treated with Ris-Rez experienced a 67% reduction in the risk of disease progression or death, with a median PFS of 5.5 months compared to 1.4 months for those receiving chemotherapy. The findings, presented at the ESMO Congress, are expected to support upcoming regulatory submissions in China.

Osteosarcoma is a rare primary bone cancer primarily affecting children and young adults. Currently, there is no standardized, approved therapy for patients who have progressed through two or more lines of systemic treatment, leaving this patient population with limited clinical options.

GSK holds exclusive development and commercialization rights for Ris-Rez outside of mainland China, Hong Kong, Macau, and Taiwan. The company is incorporating these findings into its broader global development program, which currently includes clinical trials for various solid tumors, including small cell lung cancer and metastatic castration-resistant prostate cancer.