Onconova increases sample size in Phase 3 INSPIRE pivotal trial in MDS
Onconova is moving forward with its Phase 3 INSPIRE pivotal trial following the interim analysis, consistent with the DMC's recommendation. The DMC recommended continuation of the trial with a one-time expansion in enrollment. The INSPIRE pivotal trial is studying intravenously-administered rigosertib in patients with higher-risk myelodysplastic syndromes who have progressed on, failed to respond to, or relapsed after prior hypomethylating agent therapy. The company remains blinded to the interim analysis results. The expanded INSPIRE study will continue to enroll eligible patients based on the current trial design of the overall ITT population and will increase enrollment by adding 135 patients to the original target to reach a total enrollment of 360 patients. Onconova believes that this trial is the most advanced study for a new therapeutic agent in this indication, and there are no FDA approved therapies specifically for MDS patients after failure of front-line HMAs.