There is actually one final concern from the earlier data in that the survival curve gets a little anomalous right around the 3-week mark and looks driven by some of the non-responders living longer than expected. (You can view the survival curve in this poster.)
If you look at the non-responder overall survival curve from the poster, it goes essentially straight down until about 15% of patients are left alive and flattens for about three and a half months. That seems to be enough to push the median overall survival out from what could have been 31 weeks out to 35 weeks.
What does all of this mean? Essentially, the older rigosertib data seem to indicate the phase III trial will hit its overall survival endpoint but the margin of error is small. There is always the chance that the control arm will outperform and that the treatment arm is less efficacious with the larger number of patients enrolled in the phase III study.
All the risks aside, rigosertib appears to be an active drug going against a control treatment that sets a fairly low bar for efficacy. In fact, the assumptions used by Onconova seem reasonable: "The key assumption used to calculate the required size of the ONTIME trial was based on hypothesized median survival of 30 weeks in the rigosertib treatment group and 17 weeks in the best supportive care group," according to the company's SEC filings. This appears to take into account the possibility that the 35-week median overall survival is high and that the best supportive care group will slightly outperform, which adds a nice margin for error in the trial.Onconova has a critical clinical trial catalyst coming within six months that represents a good risk/reward for investors. The additional trials in pancreatic cancer, low risk-MDS, and head and neck cancer reduce longer term risk as they represent additional shots on the goal. The rigosertib program also has some validation in that Onconova has partnered European rights to Baxter (BAX) and the Japanese and Korean rights to SymBio. Even removing the longer term valuation supports, Onconova is a relatively cheap IPO with a phase III trial reporting within six months that has a good chance of being positive. Sobek is long Onconova.
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