Well , i can’t be happy , Rollover is another trial after patients will finish our 12 months CRC trial without ICI , regardless how high is PD-L1;.
IF you look at mTNBC , overall medium survival was 7.1 months , which mean that many of our patients will die within this 12 months needlessly with high PD-L1 which is not treated ,
they will never have a chance to move to Rollover .
Of course this is not exactly the same cancer , but it is as bad so we may expect similar results imo
For physicians this is a big difference in planning treatment for a patients ..
Trust me , you will rather have a doctor who will try to amend this protocol , than the one who will keep you for 12 months with high PD-L1 , and without ICIs ..
As for Dr Lalezari , yes he did many trials , but all of them with protocols designed , and approved by someone else ,
To what we know he designed 3 trials ,
Our CD10 , our CD12 and now CRC .
We failed CD10 and CD12 ..we will see here .
In medicine is saying that good protocol design is a 70% success of the trial .
Our CRC protocol is not well design for the information we have now .
I hope he will at least try to amend it , it is late now so i don’t know , it should be amended last May .
All IMO.