CR @450-days was 28%
PR @450-days was 10%
TR @450-days was 38%
We got these results while 50% of our 25 first patients have been undertreated but, still, we managed to obtain superior CR @90-days (53% versus 41%) and CR @450-days (28% versus 19%) results than Keytruda. Keytruda was discontinued due to adverse events reactions in 11% of patients.
Moreover, Keytruda does patients discrimination as less than 25% of patients have the appropriate genetic profile suited for Keytruda.
Rough assumptions:
Considering that 50% of our 25 first patients have been undertreated but that we managed to obtain a CR of 28% @450-days, with a full set of optimized patients, we could roughly estimate that we could have doubled our CR @450-days @50%+, with a TR @70%+, more or less.
Clear candidate to FDA designation(s).