One thing to keep in mind with AP113 is that while crizotinib has shown very high initial response rates (50%+), patients quickly develop resistance, primarily from the T790M mutation. As a result, "although many patients derive substantial clinical benefit, the development of drug resistance has curbed the impact of crizotinib in this disease." http://www.pnas.org/content/108/18/7535.full
Given this situation, once it passes the safety hurdle, AP113, imo, has an excellent opportunity to move immediately to a pivotal phase 2 registration trial.
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