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Kinase Inhibitor Compound (LDK378) Receives FDA ‘Breakthrough Therapy’ Designation for NSCLC

Phase II trials are under way (Mar. 15)

The investigational compound LDK378 (Novartis) has received a “breakthrough therapy” designation from the FDA for the treatment of patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non–small-cell lung cancer (NSCLC) who have progressed during treatment with, or are intolerant of, crizotinib (Xalkori, Pfizer). Limited treatment options are available for patients with ALK+ NSCLC, who tend to be nonsmokers and younger than NSCLC patients without an ALK translocation.

A phase I study investigated the maximum tolerated dose, safety, pharmacokinetics, and antitumor activity of LDK378 in 88 patients with ALK+ advanced malignancies who had progressed during treatment with, or were intolerant of, crizotinib. Initial results from this study were presented at the European Society of Medical Oncology 2012 annual congress. The data showed marked responses in most of the patients. A response rate (including complete response [CR], partial response [PR], and unconfirmed PR) of 80% was observed in the patients who had experienced disease progression after crizotinib treatment.

Two phase II clinical trials are under way to further evaluate LDK378 in this patient population, and there are plans to initiate several phase III trials later this year. First regulatory filing is expected by early 2014.

LDK378 is a selective inhibitor of ALK. Because it is an investigational compound, the safety and efficacy profiles of LDK378 have not yet been established.

Source: Novartis; March 15, 2013.

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