Ris-Rez cuts progression risk by 67% in Phase III relapsed osteosarcoma trial
Posted on October 27, 2026
GSK and Hansoh Pharmaceutical have reported positive Phase III results showing that risvutatug rezetecan, also known as Ris-Rez, significantly improved progression-free survival in patients with relapsed or progressed osteosarcoma.
The findings come from the ARTEMIS-011 study conducted in China and were presented as a late-breaking abstract during a Presidential Symposium at the 2026 European Society for Medical Oncology Congress.
The trial enrolled patients whose osteosarcoma had progressed or returned after at least two previous lines of systemic treatment.
Ris-Rez reduced the risk of disease progression or death by 67% compared with chemotherapy.
The progression-free survival hazard ratio was 0.33, with a 95% confidence interval of 0.20 to 0.55 and a p value below 0.0001.
Median progression-free survival reached 5.5 months with Ris-Rez compared with 1.4 months in the chemotherapy group after a median follow-up of 7.1 months.
The trial met its primary endpoint, which was progression-free survival assessed by an independent review committee.
The findings represent the second positive Phase III study of Ris-Rez in China and add to the growing clinical evidence for the treatment across different solid tumours.
Hesham Abdullah, Senior Vice President and Global Head of Oncology Research and Development at GSK, said the results provide further support for Ris-Rez in difficult-to-treat cancers where treatment options remain limited.
He said the ARTEMIS-011 findings will also help inform GSK’s broader global development programme, including studies in osteosarcoma and soft tissue sarcoma.
Safety findings were consistent with previous experience with Ris-Rez in this tumour type.
Grade 3 or higher treatment-related adverse events occurred in 93% of patients receiving Ris-Rez at the 12 mg/kg dose compared with 83% of those receiving chemotherapy.
The most common severe treatment-related adverse events in both treatment groups were haematological.
Treatment-related adverse events led to discontinuation in 4% of patients receiving Ris-Rez and 2% of patients receiving chemotherapy.
Lu Xie, Principal Investigator of ARTEMIS-011 and a specialist in musculoskeletal tumours at Peking University, said patients with relapsed osteosarcoma have few treatment options once the disease has progressed following multiple therapies.
He said the progression-free survival improvement provides important new evidence in a disease where advances have historically been difficult to achieve.
Hansoh Pharma conducted the ARTEMIS-011 trial and plans to use the results to support a regulatory submission in China.
GSK holds exclusive rights to develop and commercialise Ris-Rez outside mainland China, Hong Kong, Macau and Taiwan.
The company is also advancing the treatment through a wider global development programme spanning lung cancer, prostate cancer and other solid tumours.
This includes the Phase Ib/II EMBOLD Sarcoma-202 study in patients with previously treated unresectable advanced or metastatic sarcomas, including osteosarcoma.
Related Topics and Keywords
ARTEMIS-011, Biopharma, chemotherapy, China, clinical trials, ESMO 2026, GSK, Hansoh Pharmaceutical, Oncology, osteosarcoma, pharma news, phase III, progression-free survival, relapsed osteosarcoma, Ris-Rez, risvutatug rezetecan, sarcoma, solid tumours
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