Novartis AG study published in NEJM shows LDK378 demonstrates overall response rate of 58 pct in patients with ALK+ NSCLC

Wednesday, 26 Mar 2014 05:00pm EDT 

Novartis AG:Announces New England Journal of Medicine (NEJM) published clinical trial results showing investigational compound LDK378 (ceritinib) achieved overall response rate of 58 pct.Says LDK378 median progression-free survival (PFS) of seven months in adults with advanced anaplastic lymphoma kinase positive (ALK+) non-small cell lung cancer (NSCLC) who received 400 mg or higher of LDK378 per day.Study evaluated 114 ALK+ NSCLC patients treated with LDK378, including patients who had progressed during or following treatment with commonly prescribed ALK inhibitor called crizotinib and those who had not received prior treatment with an ALK inhibitor.This study is part of ongoing Novartis clinical trial program in this patient population.Says most frequent adverse events were nausea (82 pct), diarrhea (75 pct), vomiting (65 pct), fatigue (47 pct) and increased alanine aminotransferase levels (35 pct).