I agree it's unfair to compare...
But I still maintain a "next generation" drug needs to show a 10% or better improvement in either ORR, PFS, or OS. And certainly not LDK's worse safety profile with more grade 3/4 AE's than Criz. Doesn't LDK's near equal ORR in Criz-resist and naive populations suggest mutations are being missed? But of course if AP26113 inhibits most mutants why is ORR at 75% against Chugai's 93%. I've heard some predicting '113 ORR will be higher at ESMO.
Regarding Criz I was referring to these studies:
Profile 1005 PH2 (ORR 61%) At least one prior line of chemo, 72% had 2 or more.
Profile 1007 PH3 (ORR 65%) All patients had received one prior chemo.
If Chugai data holds up I would consider it a true 2nd gen, and same for '113 with superior brain met activity and reasonable safety, if it holds ORR above 70% and shows PFS 10-20% better than Criz.
