Due to the shape of the Kaplan-Meier curves, the median when assessed by IRC is an underestimate of the effect of ridaforolimus on PFS compared to placebo, with an improvement of approximately 6 weeks in the median estimated by the hazard ratio or parametric modeling. These findings indicate that maintenance treatment of metastatic sarcoma patients with ridaforolimus significantly reduced the risk of disease progression or death.
The secondary endpoints of the study were overall survival (OS), best target lesion response, safety and tolerability, and changes in patient-reported, cancer-related symptoms. To provide as mature an OS dataset as possible, a pre-specified analysis for OS was performed with a data base cut of 21 January 2012, based upon the protocol requirement of a minimum follow up of 24 months for OS. While the trial was not powered to detect a difference in OS, the Hazard Ratio of 0.93 in favor of ridaforolimus with a median improvement of 5.3 weeks was noted. With the upper bound of the 95% confidence interval of the hazard ratio for OS at 1.12, a detrimental effect of ridaforolimus on survival is largely ruled out. Ridaforolimus treatment was also associated with a statistically significant mean target lesion size reduction of 1.3% compared to a mean target lesion size increase of 10.3 % with placebo..
The overall survival (OS) and target lesion findings support the PFS result and underscore the impact of ridaforolimus on the disease process.
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