Novartis' Zykadia Extended PFS In ALK+ NSCLC

Novartis reported positive new data from its pivotal study showing that Zykadia (ceritinib) extended progression-free survival (PFS) for an average of over 18 months in patients with anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) who took the drug as their first ALK inhibitor.

Zykadia is a selective, small-molecule ALK inhibitor which was granted early approval in April for the treatment of ALK+ metastatic NSCLC patients whose disease has progressed or who are intolerant to crizotinib. The drug works by blocking proteins that play a key role in promoting the cancer cells’ development. Zykadia is already available in the U.S. at a higher price than its predecessor Xalkori by Pfizer. According to Forbes, the drug’s $11,500 per month treatment price tag has attracted criticism, along with other expensive specialty drugs such as Gilead’s Sovaldi.

Data from the pivotal study shows that ceritinib continued to be effective in patients even when they did not receive prior ALK inhibitor treatment. The 18 month PFS is the longest reported for the lung cancer patient population, most of whom have undergone previous chemotherapy. The drug achieved an overall response rate of 61.8 percent and an average PFS of 9 months in all patients, regardless of whether or not they received previous ALK therapy. The same results were observed in patients who had brain metastases.

“These findings are very exciting because until now, most ALK+ NSCLC patients experience disease progression within less than a year of treatment with an ALK inhibitor. This is the longest median progression-free survival data we've seen in this broad patient population and it is even more striking when you consider that most of them have received up to three rounds of chemotherapy before taking ceritinib as their first ALK inhibitor,” said lead investigator Dr. Enriqueta Felip with the Vall d'Hebron University.

Two additional Phase 2clinical trials are ongoing to assess the drug against chemotherapy in treatment-naïve and previously-treated patients. Additional regulatory reviews are underway in the EU and other countries.

The company presented the results at the European Society for Medical Oncology (ESMO) 2014 Congress in Madrid, Spain.