The problem I have is the fact that they are reducing the daily dose 50% from 240 to 120. Or, put another way, they thought they needed at least 100% (double) increase from 120 to 240 to get a good therapeutic dose in HCC for it to benefit the most for the Phase 3 trial. Why did they make this assumption....? Can 120 mg BID actually hit MET hard enough to knock out the pathway? If they thought so, why bother going to 240 mg BID to begin with. This is just another checkmark next to incompetency for Pucci and Daiichi when it comes to this ENTIRE tivantinib clinical program (this is very Exelexis'esque in that they are now essentially doing a dose DE-escalation exploratory study, in an actual Phase 3 pivotal study). Just how bad could the neutropenia have been in the tivantinib arm, this early in the trial, for the DMC to recommend they DECREASE the dose...not 25%, not 33%.. but 50% ! IMO, this is stretching it, but it wreaks of Arqule and Daiichi begging the DMC to 'please dont halt the entire study, we'll drop this 50% and see where the shoe drops next' type of scenario.
Simple fact of the matter is, these things generally don't happen with very good drugs....
I sold some today, and will continue to sell on any additional strength - Phase 3 HCC is a total crapshoot now, and ESMO, while it might give a 20-30% pop, it's not enough for me to get all hot and bothered over----I'd rather find a drug that can give me 500% over the long term --- and, after this latest fiasco from Pucci & Co., I just don't see ARQL as that company.
ARQL
AI
