ARIAD Pharmaceuticals announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to AP26113 for the treatment of anaplastic lymphoma kinase positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who are resistant to crizotinib.

The Breakthrough Therapy designation was based on results from the ongoing Phase 1/2 trial that demonstrated sustained anti-tumor activity of AP26113 in patients with ALK+ NSCLC, including patients with active brain metastases.

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A total of 137 patients have been enrolled in the Phase 1/2 trial. Objective responses were observed in ALK+ NSCLC patients, and responses were observed in patients who were either TKI-naïve or resistant to crizotinib. Of the 72 ALK+ NSCLC patients evaluable for response, 52 (72%) demonstrated an objective response. The median duration of response was 49 weeks, and the median progression-free survival (PFS) was 56 weeks. In a subgroup analysis, 10 of 14 (71%) ALK+ NSCLC patients with active, untreated or progressing, brain metastases had evidence of radiographic improvement in those metastases. Of the seven evaluable TKI-naïve ALK+ NSCLC patients treated with AP26113, all demonstrated an objective response, including two complete responses.

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