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Novartis Breakthrough Therapy LDK378 shows a marked clinical response in patients with ALK+ non-small cell lung cancer
Date:6/3/2013

EAST HANOVER, N.J., June 3, 2013 /PRNewswire/ -- Novartis today announced data on its investigational compound LDK378 showing a marked clinical response in 78 patients with anaplastic lymphoma kinase positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who had progressed during or after crizotinib therapy or had not been previously treated with crizotinib1. The trial will be featured as an oral presentation (abstract #8010; Monday, June 3) at the 49th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.

The results from the study showed an overall response rate (including complete response [CR] and partial response [PR]) of 60% in patients with ALK+ NSCLC taking LDK378 (750 mg/day), which includes patients who had progressed during or after crizotinib therapy (overall response rate of 59%) and those who were crizotinib-naive (overall response rate of 62%)1. In addition to the 78 patients treated at 750 mg/day, an additional 36 patients were treated with LDK378 at 400-750 mg/day. The study is continuing to enroll patients and evaluations are ongoing. This pivotal trial will serve as the basis for the first regulatory filing, anticipated in early 2014.

The most frequent adverse events (regardless of relationship to LDK378) were nausea (73%), diarrhea (72%), vomiting (58%) and fatigue (41%). The most frequent Grade 3/4 adverse events were alanine aminotransferase increased (19%), aspartate aminotransferase increased (10%) and diarrhea (8%).

"These results confirm that LDK378 has activity in patients with ALK+ NSCLC, including those who have progressed on crizotinib, as well as those who haven't taken crizotinib," said lead investigator Alice T. Shaw , MD, PhD, Massachusetts General Hospital Cancer Center, Boston. "LDK378 may become another standard targeted
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SOURCE Novartis
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