Placebo-controlled phase 2 trial of regorafenib maintenance after first-line chemotherapy for advanced non-adipocytic soft tissue sarcoma

There is no approved maintenance therapy for advanced non-adipocytic soft tissue sarcoma (aNASTS). The placebo-controlled multicenter phase 2 EREMISS trial in France evaluated regorafenib maintenance for aNASTS in patients with partial response or stable disease after first-line doxorubicin-base chemotherapy. The median progression-free survival (primary endpoint) was 5.6 months with regorafenib versus 3.5 months with placebo (HR 0.53; p=0.001). The proportion of patients with grade ≥ 3 adverse events was 56.3% with regorafenib and 4.6% with placebo. The authors conclude that regorafenib significantly delayed progression after first-line treatment for aNASTS