Onconova's rigosertib misses in Phase III MDS trial
Onconova Therapeutics Inc. (NASDAQ:ONTX) said IV rigosertib plus best supportive care (BSC) missed the primary endpoint of improving median overall survival (OS) vs. BSC alone in the Phase III ONTIME trial to treat myelodysplastic syndromes (MDS) (8.2 vs. 5.8 months, p=0.27). A post-hoc analysis showed rigosertib significantly improved OS vs. BSC in a subset of patients who had progressed on or failed previous treatment with hypomethylating agents (p=0.022) but did not significantly improve OS vs. BSC in the subset of patients who had relapsed after prior hypomethylating agents.
Onconova has an SPA from FDA for the open-label trial, which enrolled 299 MDS patients who had progressed on, failed or relapsed after prior therapy with hypomethylating agents. The company also received scientific advice from EMA for the trial. Additional data will be presented at the American Society for Clinical Oncology meeting in Chicago. ...