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esedu

04/26/16 10:42 AM

#15683 RE: pharmeng #15669

The combo trial is designed around a 6-month primary endpoint. Overall survival divergence is probably not going to be statistically significant in that time frame.

To quote the press release:

The primary objective of the study is to determine the effectiveness of the combination by measuring Overall Response Rate [ORR = Complete Response (CR) + Partial Response (PR)] by RECIST and Progression Free Survival (PFS) rate at 6 months.   Secondary endpoints will be safety and immune and correlation of FRa-specific immune responses with clinical efficacy.



Overall Response Rate and Progression Free Survival at 6 months. That's all that's needed to justify further investigation, ie a Phase 3 trial.

Things can move VERY quickly on this particular front. My guess is that once we get results from this trial, we'll see if there's any truth behind buyout speculations, because at that point TPIV200 will be PROVEN.