Clinical TrialJul 28, 2026, 01:12 PM
GSK's Ris-Rez shows positive Phase III results in osteosarcoma
AI Summary
GSK's licensor, Hansoh Pharmaceutical Group Co., Ltd., announced positive results from a second Phase III trial (ARTEMIS-011) for risvutatug rezetecan (Ris-Rez) in China. The study met its primary endpoint of progression-free survival in patients with relapsed osteosarcoma, demonstrating statistically significant and clinically meaningful improvements compared to chemotherapy. This adds to previous positive data in small-cell lung cancer, strengthening confidence in Ris-Rez, which GSK is developing globally for various tumor types, including lung and prostate cancers.
Key Highlights
- Hansoh Pharma announced positive Phase III results for Ris-Rez in relapsed osteosarcoma in China.
- The ARTEMIS-011 study met its primary endpoint of progression-free survival (PFS).
- Ris-Rez, a B7-H3-targeted ADC, showed statistically significant and clinically meaningful PFS improvement.
- Consistent benefit was observed across secondary endpoints, including overall survival.
- The safety profile of Ris-Rez was consistent with prior findings, with no new safety signals.
- GSK is advancing global development of Ris-Rez outside China for multiple solid tumors.
- Ris-Rez has US FDA Breakthrough Therapy Designation for relapsed or refractory osteosarcoma.
- These results follow recent positive pivotal data for Ris-Rez in small-cell lung cancer.
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