Novartis AG (NVS) on Monday announced data on its investigationalcompound LDK378 showing a marked clinical response in 78 patients withanaplastic lymphoma kinase positive (ALK+) metastatic non-small cell lung cancer(NSCLC) who had progressed during or after crizotinib therapy or had not beenpreviously treated with crizotinib.
The trial will be featured as an oral presentation at the 49th Annual Meeting of the American Society of Clinical Oncology in Chicago.
The results from the study showed an overall response rate (including completeresponse [CR] and partial response [PR]) of 60% in patients with ALK+ NSCLCtaking LDK378 (750 mg/day), which includes patients who had progressed during orafter crizotinib therapy (overall response rate of 59%) and those who werecrizotinib-na?ve (overall response rate of 62%).
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 andevaluations are ongoing. This pivotal trial will serve as the basis for thefirst regulatory filing, anticipated in early 2014.
The most frequent adverse events (regardless of relationship to LDK378) werenausea, diarrhea, vomiting and fatigue. The most frequent Grade 3/4 adverse events were alanine aminotransferase increased, aspartate aminotransferase increased and diarrhea.
In March, LDK378 received Breakthrough Therapy designation from the US Food andDrug Administration. The designation is intended to expedite thedevelopment and review of drugs that treat life-threatening conditions and showimprovement over available therapies.
Currently, two Phase II clinical trials are actively recruiting patientsworldwide. One study focuses on patients with ALK+ NSCLC who were previously treated with chemotherapy and crizotinib. The second study examines LDK378 in patients who are crizotinib-naive. In addition, Phase III clinical trials are planned to begin inthe coming months, aiming to enroll more than 1,100 patients with ALK+ NSCLC atsites worldwide.
Non-small cell lung cancer is the most common type of lung cancer accounting for85-90% of all cases. About 3-8% of patients with NSCLC have the ALKgene mutation. There are limited treatment options for patients with ALK+NSCLC, who tend to be non-smokers and younger than NSCLC patients without an ALKtranslocation.
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