Successful Zykadia trial for ALK+ NSCLC patients - Novartis
Novartis has announced data showing Zykadia (ceritinib, previously known as LDK 378) shrank tumors in patients with anaplastic lymphoma kinase-positive (ALK+) Non-Small Cell Lung Cancer (NSCLC), including those who had received previous treatment with an ALK inhibitor as well as patients receiving one for the first time. Results were also observed in patients with ALK+ NSCLC who entered the study with brain metastases. The study is presented at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.
Among a combined population of 246 NSCLC patients, ceritinib achieved an overall response rate (ORR) of 58.5% and a median progression-free survival (PFS) of 8.2 months. Of these, 124 patients entered the trial with brain metastases and achieved an ORR of 54.0% and a median PFS of 6.9 months. The most common adverse events, occurring in more than half of patients, were diarrhea, nausea, vomiting, abdominal pain and fatigue. Approximately 2-7% of patients with NSCLC harbor the ALK gene rearrangement, which causes cancer growth. These patients are candidates for treatment with a targeted ALK inhibitor. Patients with ALK+ NSCLC are often younger than the average NSCLC patient, and in many cases have never smoked.
The study presented at ASCO served as the basis for the FDA approval of Zykadia in April 2014, which followed the FDA's Breakthrough Therapy designation.
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