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LDK 378 trial for ALK + NSCLC patients published in NEJM - Novartis

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Last updated:29th Mar 2014
Published:29th Mar 2014
Source: Pharmawand

Novartis announced that The New England Journal of Medicine (NEJM) published clinical trial results showing the investigational compound LDK 378 (ceritinib) achieved an overall response rate (ORR, including complete response [CR] and partial response [PR]) of 58% and a 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.

The study evaluated 114 ALK+ NSCLC patients treated with LDK 378, including patients who had progressed during or following treatment with a commonly prescribed ALK inhibitor called crizotinib and those who had not received prior treatment with an ALK inhibitor. This study is part of the ongoing Novartis clinical trial program in this patient population.

The FDA designated LDK378 as a Breakthrough Therapy and these pivotal data published in NEJM served as the basis for the first regulatory filing for LDK 378.

See- Shaw A, et al. Ceritinib in ALK-Rearranged Non-Small-Cell Lung Cancer. N Engl J Med. 2014;370(13):1189-97.

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