The company said that results were also observed in patients with ALK+ NSCLC who entered the trial with brain metastases.
Seoul National University Hospital lead investigator Dong-Wan Kim said ceritinib showed 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," said ceritinib.
The trial included a total of 246 NSCLC patients among which ceritinib achieved an overall response rate (ORR) of 58.5% and a median progression-free survival (PFS) of 8.2 months.
Out of these patients, 124 entered the trial with brain metastases and achieved an ORR of 54.0% and a median PFS of 6.9 months.
Most common adverse events, occurring in more than half of patients, were diarrhea, nausea, vomiting, abdominal pain and fatigue].
Novartis Oncology Development and Medical Affairs global head Alessandro Riva said the company is happy that ceritinib has showed consistent activity as it analyzes 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.
"The recent FDA approval of Zykadia brought an important new treatment option to patients in the US and we are pleased to be working with regulatory authorities around the world to bring ceritinib to additional patients," Riva said.