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FDA grants ‘breakthrough’ designation for ALK-positive NSCLC therapy

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The FDA granted breakthrough therapy designation for an investigational treatment for patients with anaplastic lymphoma kinase-positive metastatic non–small cell lung cancer who are resistant to crizotinib, according to the drug’s manufacturer.

AP26113 (Ariad Pharmaceuticals) is an investigational oral inhibitor of anaplastic lymphoma kinase (ALK) designed to overcome mutation-based resistance, which has been observed in patients who initially responded to crizotinib (Xalkori, Pfizer) and then relapsed.

“We are very pleased that the FDA has granted breakthrough therapy designation to AP26113,” Harvey J. Berger, MD, chairman and CEO of Ariad, said in a press release. “We are encouraged by the clinical data on AP26113 that were presented recently at the European Cancer Congress, particularly in patients whose tumor had spread to the brain. We are focused on accelerating patient enrollment in the ongoing ALTA trial and on planning a front-line trial of AP26113 in treatment-naive patients.”

The FDA based its designation on results from an ongoing phase 1/2 trial that demonstrated sustained antitumor activity of AP26113 in patients with ALK-positive NSCLC, including patients with active brain metastases.

Updated clinical data from the phase 1/2 trial of AP26113 were recently presented at the annual meeting of the European Society for Medical Oncology, according to a press release. One hundred thirty-seven patients have been enrolled in the trial in the United States and Europe, with objective responses observed in ALK-positive NSCLC patients, as well as those who were either TKI-naive or -resistant to crizotinib.

Of the 72 ALK-positive NSCLC patients evaluable for response, 52 (72%) demonstrated an objective response. The median duration of response was 49 weeks, and the median PFS was 56 weeks.

In a subgroup analysis, 71% of ALK-positive NSCLC patients with active, untreated or progressing brain metastases demonstrated evidence of radiographic improvement in those metastases. Among seven evaluable TKI-naive ALK-positive NSCLC patients treated with AP26113, all exhibited an objective response, including two complete responses.