These p-values ARE getting close to significance ("Progression free survival in the full data set was 2.8 months vs. 4.2 months (p=0.076) and overall response rate was 8% vs. 16% (p=0.078) for D vs. G+D, respectively."), and with a tripling of N in Phase 3 (from 172 to 500) have an excellent chance of reaching significance.
Plus, take a look at these ALREADY significant p's (0.01 and 0.02) ...
Survival outcomes for the remaining populations defined by the specified stratification factors (D vs. G+D):
Time since diagnosis
advanced disease 6 mo 50%) subsets of the all-adeno population. It sounds like Synta will soon be discussing with regulatory agencies how it can best use this data in the Phase 3.
Finally, it doesn't hurt that the poster's Kaplan-Meier overall survival chart looks like median-OS will probably hit 13-16 months after factoring in the flattening of the curve in the day 240-340 part of the graph. In ohter words, about a double vs. the control arm median-OS of 7.4 months.!!
Somehow my last post got compressed. My middle point was that patients with a Time since Diagnosis of 6 mo (N=108) have a Hazard ratio of 0.37 (p=0.01) and patients with a Smoking Status of Never/past (N=130) have a Hazard ratio of 0.48 (p=0.02).
As far as I know this is new information and it's huge!