113 in ALK met my own expectation, but I don't think it met best in class expectation. Efficacy wise, it is not differentiated from LDK378. The ORR reported by 113 and 378 are not directly comparable because 113 used best ORR while 378 used strictly confirmed ORR standard. Safety differentiation is relatively minor because SAEs and Grade 3/4 AEs aren't really differentiated. Overall, the 3 second generation ALK inhibitors are close and going to be very competitive IMO.
113 EGFR T790M does have hint of efficacy. Once test of presence of T790M mutation before entry criteria is used, result could surprise because none of 5 patients with documented T790M during most recent EGFR TKI treatments had progressed (2 SD, 3 NS). As of how it would compare to CO1686, it is impossible to say at this point. I do think surprise could come here rather than ALK because of competitive landscape.
