Study
| Phase 1, open-label, multicenter study (C-800-01) |
| Patients with relapsed/refractory metastatic sarcomas |
| Botensilimab (1 or 2 mg/kg IV Q6W) + Balstilimab (3 mg/kg IV Q2W) for up to 2 years |
Efficacy
| ORR: 19.2% |
| Angiosarcoma subgroup ORR: 27.8% |
| mDoR: 21.7 mos [1.9–NR] |
| mPFS: 4.4 mos (95% CI: 2.8–6.1) |
| 6-mo PFS: 36% (95% CI: 21.9–50.2) |
| mOS: NR (95% CI: 14.0–NR) |
| 12-mo OS: 69% (95% CI: 52.3–80.8) |
Safety
| Grade ≥3 AEs: 17.2% |
| Most common TRAE: Diarrhea/colitis (35.9%, grade 3: 6.3%) |
| Other AEs: Fatigue (26.6%), rash (17.2%), hypothyroidism (10.9%) |
| Immune-related AEs: Skin reactions (17.2%), managed with steroids/TNF-α blockers |
| No grade 4–5 TRAEs |
J Clin Oncol 2025;43:1358-68
http://doi.org/10.1200/JCO-24-02524
Reviewed by Ulas D. Bayraktar, MD on Apr 22, 2025
