AVEO Pharmaceuticals, Inc. (AVEO)

[Doctor Detroit]

Apologies to anyone who read my post yesterday; I made some rookie errors, but I think I understand this a little better now. It helps my simple brain to just exclude Sorafenib. In the Dovitinib vs Sorafenib study, only 2 of 282 Sorafenib patients were progression free after 12 months. And so for purposes of TIVO-3 (which fully enrolled in June 2017), it is safe to assume that Sorafenib has done its thing and is no longer a factor (i.e., all 161 sorafenib participants have had disease progression events).

So really, what we have now is a one drug trial of 161 TIVO participants with data readout triggered at reaching 94 PFS events (the 255 PFS events required including sorafenib participants, minus the 161 sorafenib participants).

The mPFS will be determined based on where the 80th patient falls (the 50% mark), but we don’t get the data until we hit the 94th PFS event. So, for all we know, the 80th patient has already had a PFS event but we are waiting out the 94th PFS event for data.

The only thing we can say with certainty is that at least 93 participants have not had a PFS event yet. So, at a minimum 93 of 161 participants (57.7%) remain disease free for at least 8 months (assuming worst case scenario of dosing in August 2017 and a two month data lag). That allows us to predict with absolute certainty that the trial’s goal (mPFS of six months) has been met and exceeded by two months.