Novartis AG (NVS) on Monday 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 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 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-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 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, 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 and
Drug Administration. The designation is intended to expedite the
development and review of drugs that treat life-threatening conditions and show
improvement over available therapies.
Currently, two Phase II clinical trials are actively recruiting patients
worldwide. 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 in
the coming months, aiming to enroll more than 1,100 patients with ALK+ NSCLC at
sites worldwide.
Non-small cell lung cancer is the most common type of lung cancer accounting for
85-90% of all cases. About 3-8% of patients with NSCLC have the ALK
gene mutation. There are limited treatment options for patients with ALK+
NSCLC, who tend to be non-smokers and younger than NSCLC patients without an ALK
translocation.
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