Study
| Double-blind, placebo-controlled, randomized phase 2 trial (EREMISS) |
| Advanced non-adipocytic soft tissue sarcomas post 1st-line doxorubicin-based chemotherapy |
| Regorafenib 120 mg/day (3 wks on/1 wk off) vs. placebo |
Efficacy
| mPFS: 5.6 mos vs. 3.5 mos (regorafenib vs. placebo) (HR: 0.53 [0.36–0.78]) |
| mOS: 27.6 mos vs. 20.5 mos (HR: 0.78 [0.50–1.22]) |
| Investigator-assessed mPFS: 6.8 mos vs. 3.6 mos (HR: 0.59 [0.40–0.85]) |
| Disease control (CR/PR/SD): 80% vs. 49% |
Safety
| Grade ≥3 AEs: 56.3% vs. 4.8% |
| Most common Grade ≥3 AEs (regorafenib): fatigue (9.4%), hypertension (7.8%), rash (7.8%) |
| Treatment discontinuation due to AEs: 28.1% |
Ann Oncol. Accepted on March 31, 2025
http://doi.org/10.1016/j.annonc.2025.03.024
Reviewed by Ulas D. Bayraktar, MD on Apr 22, 2025
