ALK+ Metastatic NSCLC Therapy Designated Breakthrough Therapy

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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