The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to an investigational agent AP26113 for patients with anaplastic lymphoma kinase (ALK)-positive metastatic non–small cell lung cancer (NSCLC) who are resistant to Xalkori® (crizotinib) This designation is based on results from an ongoing phase I/II trial showing sustained antitumor activity of AP26113 in patients with ALK-positive NSCLC, including patients with active brain metastases.

Lung cancer is the leading cause of cancer death in the U.S. and around the world. Up to 7 percent of NSCLC’s have an abnormal version of the ALK gene. Lung cancers with this abnormality typically occur in non-smokers. The abnormal gene contributes to the growth and development of cancer cells.

Xalkori (crizotinib) is a targeted oral medication that blocks the protein produced by the ALK gene. It works by works by binding with and inhibiting the action of the enzyme that is produced by the mutated gene. Xalkori has become a standard treatment for advanced ALK-positive NSCLC—but most patients will become resistant to it and are left with limited treatment options.

Updated clinical data from a phase I/II trial of AP26113 were recently shared at presented at the European Society for Medical Oncology meetings. The researchers reported that a partial or complete disappearance of cancer was observed in 72% of the ALK-positive NSCLC patients, and responses were observed in patients who were either tyrosine kinase inhibitor–naive or resistant to Xalkori. The average duration of response was 49 weeks, and on average patients survived 56 weeks without cancer progression.

Of significant interest was the observation that of the seven ALK-positive NSCLC patients with brain metastases treated with AP26113, all demonstrated an objective response, including two complete responses.

Overall, treatment with AP26113 was well tolerated. The data from this study will serve as the basis for regulatory application to the FDA, with action expected this year. Breakthrough Therapy Designation is intended to expedite the development and review of drugs that treat serious or life-threatening conditions if the therapy has demonstrated substantial improvement over an available therapy on at least one clinically significant endpoint.

Reference: ESMO 2014 Congress (Abstract 1292P).

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