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Re: iandy post# 20614

Thursday, 07/19/2012 2:02:32 PM

Thursday, July 19, 2012 2:02:32 PM

Post# of 80490
While the LDK378 results presented at ASCO were impressive, as long as AP113 is able to show similar efficacy with a better safety profile, AP113 will clearly offer the best treatment option. And, yes, I do believe AP113 has the potential to show better efficacy outright than LDK378 - at least in part because AP113 inhibits both alk and egfr which are both expressed in a subset of NSCLC patients.

"LDK378 showed substantial activity in patients with ALK-positive NSCLC. The overall response rate was 81% among the 26 patients previously treated with crizotinib who then received LDK378 at doses of 400 mg per day or greater. The objective response rate among all 33 patients with NSCLC receiving at least 400 mg per day was 67%"

"In the dose-escalation phase of the study, patients received between 50 mg and 750 mg of LDK378 per day. Most patients (83%) received at least 400 mg, the dose thought to be required for clinical activity. The maximum tolerated dose was 750 mg per day, although dose-limiting toxicities were observed in patients receiving 400 mg per day and higher. Common adverse events included nausea (59%), vomiting (54%), diarrhea (48%), fatigue (21%), and dyspnea (16%). Serious adverse events included one case each of transaminase elevation, vomiting, dehydration, and interstitial lung disease. These were all reversible after stopping treatment."

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