Efficacy and safety of risvutatug rezetecan versus gemcitabine plus docetaxel in relapsed/refractory advanced osteosarcoma: Primary results from the ARTEMIS-011 phase 3 trial.

Authors

L Xie, W Yao, Y Hua, W Luo, C Tu, J Wang, J Chen, B Li, D Zhu, X Li, Y Xiao, J Ma, H Hu, M Fang, Z Huang, H Wang, Q Liu, Y Jin, X Zhang, X Niu, X Tang

Published in

Annals of oncology : official journal of the European Society for Medical Oncology. Oct 26, 2026. Epub Oct 26, 2026.

Abstract

Patients with relapsed/refractory (R/R) osteosarcoma have a poor prognosis and high unmet needs for effective therapies. Herein, we report primary results from ARTEMIS-011, the multicenter, open-label, randomized phase 3 trial of risvutatug rezetecan (Ris-Rez), a B7-H3-directed antibody-drug conjugate, in Chinese patients with R/R osteosarcoma after ≥2 prior lines of systemic treatment.
Patients (≥12 years) were randomized 2:1 to Ris-Rez 12.0 mg/kg or gemcitabine plus docetaxel (GD), every 3 weeks, stratified by age and lung metastasis. The primary endpoint was progression-free survival (PFS) by blinded independent central review (BICR); secondary endpoints included overall survival (OS) and safety.
At data cutoff (June 17, 2026), 80 patients were treated with Ris-Rez and 42 with GD; median follow-up was 7.1 months. Median age was 21 years (IQR, 17-34) with 31 (25%) adolescents (12 to <18 years). BICR-assessed PFS significantly improved with Ris-Rez compared with GD (median, 5.5 vs 1.4 months; HR, 0.33; 95% CI, 0.20-0.55; P<0.0001). OS data were immature, with a HR of 0.51 (95% CI, 0.21-1.23). With longer treatment duration with Ris-Rez than GD (median, 4.5 vs 1.5 months), adverse events (AEs) were reported in all patients. No treatment-related AEs (TRAEs) led to death. Grade ≥ 3 TRAEs occurred in 93% of patients with Ris-Rez and 83% with GD, and serious TRAEs in 64% versus 29%, which were predominantly hematologic. TRAEs led to dose reductions in 71% versus 26% of patients with Ris-Rez versus GD, respectively, and permanent discontinuation was infrequent (3.8% vs 2.4%).
In ARTEMIS-011, Ris-Rez demonstrated a statistically significant and clinically meaningful improvement in BICR-assessed PFS compared to GD, alongside a numerical trend toward improved OS and manageable safety profile with dose modifications and supportive care, offering a promising new treatment option for patients with R/R advanced osteosarcoma.

PMID:
42933637
Bibliographic data and abstract were imported from PubMed on 27 Oct 2026.

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