Trabectedin brings hope to advanced soft tissue sarcoma patients5 Jun 2015
Data from the Phase 3 multicentre study SAR3007 demonstrated a significant improvement in progression-free survival (PFS) with trabectedin (Yondelis). The study compares trabectedin to dacarbazine in patients with advanced liposarcoma (LPS) or leiomyosarcoma (LMS) previously treated with an anthracycline and at least one additional chemotherapy regimen. The data was announced by the pharmaceutical company Janssen.
The largest randomized Phase 3 study in this population
SAR3007 is the largest randomized Phase 3 study ever conducted in this patient population. In the trial, trabectedin significantly reduced the risk of disease progression or death by 45% compared with those who received dacarbazine, with results validated through an audit by independent radiologists.
The improved PFS benefit with trabectedin treatment was consistently observed across all clinically relevant subgroups and was further supported by an increased objective response rate (ORR), a longer duration of response (DOR), and a higher clinical benefit response rate as compared to dacarbazine.
The trial is still ongoing
At the interim analysis for overall survival (OS), the trial had not met the primary endpoint of OS. The study is ongoing to determine the final OS results, which will be presented at a future meeting. The results for the secondary efficacy endpoints are mature. Safety findings were consistent with the well-characterized safety profiles of both agents. Drug-related deaths occurred in 2.1% of patients in the trabectedin group versus 0% of patients in the dacarbazine group.
Trabectedin is approved in 77 countries in North America, Europe, South America and Asia under the trade name Yondelis for the treatment of advanced STS as a single agent.
Source: eCancer News