Drug shrank tumors in most ALK+ non-small cell lung cancer patients

5 Jun 2014

In a study, ceritinib shrank tumors in patients with ALK+ non-small cell lung cancer, regardless of prior treatment, in general.

In particular, the results were applicable for 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+ non-small cell lung cancer (NSCLC) who entered the study with brain metastases1.

"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," said lead investigator Dong-Wan Kim, MD, PhD, Seoul National University Hospital. "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."

Results from 246 non-small cell lung cancer

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 fatigue1.

Approximately 2-7% of patients with NSCLC harbor the ALK gene rearrangement, which causes cancer growth3. 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 smoked4.

"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," said Alessandro Riva, MD, Global Head, Novartis Oncology Development and Medical Affairs. "The recent FDA approval of Zykadia (the brand name of ceritinib) 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."

The study presented at ASCO served as the basis for the US Food and Drug Administration (FDA) approval of Zykadia in April 2014, which followed the FDA's Breakthrough Therapy designation, and occurred less than three and a half years after the first patient entered a clinical trial. Additional ongoing regulatory reviews are currently underway in the European Union, Argentina and Switzerland.


Source: Medical News Today

No Comment