"Mature Phase 2 data indicates a p- value of .70 for overall survival and a P value of .40 for Metastases, for all you statisticians out there please clarify if this overall "survival" p-value of .70 is statistically significant ( always considered .50 the cut off) or will this be clarified at ASCO meeting on 30th. If I am misinterpreting the data, please have someone who knows give us a comment.
Raw data was HR=0.60 with p=0.07 which is pretty impressive considering the sample size. Phase 2 oncology studies are rarely powered for survival, and this one was no exception. Most recent pivotal prostate cancer trials enrolled ~500 patients per trial (DNDN, CEGE) with survival as a primary endpoint. The notion of P=0.05 demonstrating statistical significance or not is meaningless for a phase 2. Statistically speaking it's an arbitrary number. However, FDA generally requires 2 independent studies demonstrating a P<0.05 for approval.
What we learn from the phase 2 OGXI study is that the probability of hitting p<0.05 with a a better powered (i.e. with a larger sample size) phase 3 is very high. Further, what is impressive with this dataset is that the PROSPECTIVELY defined multivariate analysis accounting for prognostic factors demonstrated HR=0.54 with a P=0.04. i.e. if you account for certain 'imbalances' in the trial's arms, you see better seperation between the study arms.
To make a long story short - OGXI has excellent probability of replicating the survival benefit observed in a future, better powered study. And more importantly, it's likely to be a highly partenable asset for a pharma company. I wouldn't be surprised to see a minimum $50 million ufront deal for the rights of this drug excluding future milestones before year-end. That alone would translate to >$10/share of cash for OGXI stock.
Agreed phase II survival data is very promising and makes it very attractive. What do you make of the relatively short Docetaxel treatment duration in the control arm (7 cycles) and median survival (16.9 months) when compared to those from the TAX327 trial (9.5 cycles and 18.9 months)? TIA.