I just think Ridaforolimus, if combined with another drug, would likely have been a "shoe-in" for success in the Phase 3 trial.
I am not so cheery on the outcome as a standalone drug in sarcoma. I think there is a lot of risk in the SUCCEED trial, namely the placebo group washing out the overall results.
Sarcoma is a very very broad term. There are many different types of sarcoma. This trial is an "all comers" trial in that all types of sarcoma are being thrown into the trial, and I believe Rida will work very well in some of these patients, but will show very little evidence of success in some types of sarcoma. Let's just put it this way...if the drug was a "shoe in", the 2nd interim would have stopped the trial.
Yeah, investigators call lots of things "best in class"...I'm not impressed.
mTOR as a class will be best served using biomarkers and combinations.
And of course I'll be called a basher for saying all this, so...whatever.....