Novartis' Zykadia Reduced Tumor Size In Patients With ALK+NSCLC

Novartis announced positive data for Zykadia (ceritinib) in a Phase I single-arm study, which showed that the drug shrank tumors in patients with anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) regardless of prior ALK inhibitor treatment.

Ceritinib achieved an overall response rate (ORR) of 58.5 percent with a median progression-free survival of 8.2 months. Lead investigator Dong-Wan Kim of the Seoul National University Hospital said, “Ceritinib demonstrated a high level of activity in patients with ALK+ NSCLC regardless of whether or not they were previously treated with an ALK inhibitor. Another noteworthy finding in this study population is that ceritinib exhibited activity among patients whose cancer had metastasized to the brain, which is currently one of the biggest challenges in treating ALK+ NSCLC."

An estimated 2 to 7 percent of patients with NSCLC have the ALK gene rearrangement, which results in cancer growth. Targeted ALK inhibitors are indicated for this patient group. Zykadia is an FDA-approved prescription medicine indicated in the U.S. for the treatment of patients with ALK+ metastatic NSCLC who have progressed on or are intolerant to crizotinib. The drug has been approved under accelerated approval based on data showing the extent and duration of tumors’ response.

Alessandro Riva, Global Head of Novartis Oncology Development and Medical Affairs, said, “We are encouraged that ceritinib has demonstrated consistent activity as we analyze data from additional patients with longer follow-up, further supporting the potential of ceritinib to make a difference in the lives of patients with ALK+ NSCLC.” Riva said that following the recent accelerated FDA approval, the company is working with regulatory authorities around the world for the approval of ceritinib. Additional applications are under regulatory review in the EU, Switzerland, and Argentina.

Data from the study, which formed the basis of the FDA approval of Zykadia last month, is being presented by Novartis at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.