I wonder if today's DSMB report was triggered by the 91 event threshold as the trial originally was designed to do. Remember the trial was recently amended to increase the triggering number of events to 105. Early in '16 at a conference, Dror estimated the interim(at 91 events) at between the first and second quarter of '17--which is now. Today's press release mentions that based on the amount of events that triggered today's DSMB meeting, the interim analysis can be predicted at mid '17. There is a date(which the company knows)wherein 50 % of patients will have enrolled into the trial. My hunch is that date is sometime in July, based on the escalating enrollment of the trial which began in August of '15 and completed enrollment right before year's end. So, if my speculation is correct, 105 events will have occurred and 50 percent of patients will have had 12 months of potential drug plus avastin/or avastin by sometime in July of 2017. If my guess is correct, the formal interim analysis will occur maybe a month or so after July of 2017--hence the midyear time frame.
Interestingly, when you look back at the KM curves from the phase II trial, the greatest separation of curves between the two cohorts in rGBM occurred at around 12 months. I would bet VBLT is looking at the potential modeling of possible outcomes based on the expected 8-9 month survivorship of Avastin. My own guess would be a 2-3 month separation of the KM curves when the trial is finished.
