ARTEMIS-011 — Risvutatug Rezetecan (HS-20093) Versus Chemotherapy in Relapsed/Refractory Osteosarcoma

Phase 3 · 2026 · Osteosarcoma, Sarcoma

Design

Open-label, randomized phase 3 trial: risvutatug rezetecan (HS-20093, a B7-H3-directed antibody-drug conjugate) versus investigator's choice of chemotherapy in patients with relapsed/refractory osteosarcoma after ≥2 prior lines of systemic therapy.

Population

Patients with osteosarcoma who progressed or relapsed after ≥2 prior lines of systemic therapy (including MAP/MAPI-based regimens); enrolled globally.

Primary Endpoint

Independent Review Committee (IRC)-assessed progression-free survival (PFS)

Key Result

Top-line results (July 28, 2026 Hansoh Pharma press release): risvutatug rezetecan met its primary endpoint with a statistically significant and clinically meaningful improvement in IRC-assessed PFS versus chemotherapy. Consistent benefits were observed on secondary endpoints including overall survival (OS) and investigator-assessed PFS, with no new safety signals. Full HR, median PFS, and detailed efficacy data are pending peer-reviewed publication following regulatory engagement. Hansoh Pharma intends to engage Chinese regulators (CDE/NMPA) for a BLA submission; GSK holds ex-China…

Guideline Impact

Top-line data pending peer-reviewed publication and regulatory review; Hansoh Pharma planning BLA engagement with CDE/NMPA; ex-China rights held by GSK. Guidelines to be updated following full data publication and approval.