ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced clinical data on its investigational anaplastic lymphoma kinase (ALK) inhibitor, brigatinib, were published in The Lancet Oncology (Gettinger, S.; ed al. The Lancet Onc. 2016, DOI: 10.1016/S1470-2045(16)30392-8 Published 8 November 2016). ARIAD has submitted a New Drug Application (NDA) for brigatinib to the U.S. Food and Drug Administration (FDA), seeking U.S. marketing approval for patients with metastatic ALK-positive (ALK+) non-small cell lung cancer (NSCLC) who are resistant or intolerant to crizotinib. "The publication reports the results of the first clinical evaluation of brigatinib in patients with advanced malignancies, including ALK+ NSCLC," stated Scott N. Gettinger, M.D., associate professor of medicine at Yale Cancer Center and lead author. "Brigatinib yielded responses in the majority of patients with crizotinib-treated ALK+ NSCLC, with median progression free survival of over one year. Additionally, responses in the brain were achieved in this crizotinib refractory population. Early onset pulmonary adverse events, which occurred in eight percent of patients, generally within 48 hours of first dose, appeared to be related to starting dose." The data published this week include safety analyses on all patients in the trial (N=137) and efficacy analyses on all patients with ALK+ NSCLC (n=79). Of the 79 ALK+ NSCLC patients, all but eight had previously been treated with crizotinib. With patient data as of June 2015, the median time on treatment for ALK+ NSCLC patients was 15.4 months (range, 0.03 - 39.4 months, ongoing). The confirmed objective response rate (ORR) was 62% (44/71) in ALK+ NSCLC patients with prior crizotinib treatment. The median progression free survival (PFS) of ALK+ NSCLC patients previously treated with crizotinib was 13.2 months. Eight ALK+ NSCLC patients in the trial were crizotinib-naive. Of these, all eight achieved a confirmed objective response, including three complete responses. At the time of analysis, median PFS was not reached in these patients. Brain metastases were identified in 63% of ALK+ NSCLC patients (50/79) at baseline. The intracranial ORR was 53% (8/15) among evaluable patients with measurable brain metastases.