Novartis Reports Positive Trial Results For LDK378 In ALK+ NSCLC

Novartis announced that The New England Journal of Medicine (NEJM) has published positive trial results for its investigational compound LDK378 (ceritinib) for the treatment of patients with lung cancer. The data served as the basis for a regulatory authorization application to the US Food and Drug Administration (FDA), which is expected to give its decision this year.

Ceritinib, an investigational compound, reached an overall response rate of 58% and a median progression-free survival (PFS) of seven months in adult patients with advanced anaplastic lymphoma kinase positive (ALK+) non-small cell lung cancer (NSCLC). Patients involved in the Phase I single-arm study received 400 mg or higher of LDK378 per day to investigate the maximum tolerated dose, pharmacokinetics, safety, and preliminary antitumor activity of the drug.

Alice T. Shaw, MD, PhD, of the Massachusetts General Hospital Cancer Center in Boston and lead investigator in the study, said, “The majority of patients in the study experienced a clinical response to LDK378. In addition, responses were seen in untreated lesions in the central nervous system in patients who previously received crizotinib. These results are important because most patients experience a disease relapse less than a year after starting crizotinib and have limited treatment options.”

NSCLC is the most common type of lung cancer. The disease accounts for 85-90% of all cases, with 2-7% of patients possessing the ALK gene rearrangement which increases cancer cell growth.  There are limited treatment options for patients with ALK+ NSCLC at present.

Alessandro Riva, President of Novartis Oncology ad interim and Global Head, Oncology Development and Medical Affairs, said, “These pivotal data published in NEJM served as the basis for our first regulatory filing for LDK378. We are pleased that the FDA has accepted our application, and we look forward to working with the FDA and health authorities worldwide to bring this important treatment option to patients in need as swiftly as possible.”

Several major clinical studies investigating treatment with LDK738 are currently ongoing in over 300 study centers across more than 30 countries.