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ARIA > SEC Filings for ARIA > Form 8-K on 24-Mar-2014All Recent SEC Filings




Other Events, Financial Statements and Exhibits

ITEM 8.01 Other Events.

On March 24, 2014, ARIAD Pharmaceuticals, Inc. (the "Company") issued a press release announcing the initiation of a global pivotal Phase 2 trial of AP26113 in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who were previously treated with crizotinib. The ALTA (ALK in Lung Cancer Trial of AP26113) trial is designed to determine the safety and efficacy of AP26113 in refractory NSCLC patients who test positive for the anaplastic lymphoma kinase (ALK+) oncogene.

Approximately 220 patients with ALK+ NSCLC who have been treated with and progressed on their most recent crizotinib therapy will be randomized one-to-one to receive either 90 mg of AP26113 once per day (QD) continuously, or a lead-in dose of 90 mg QD for seven days followed by 180 mg QD continuously. The primary endpoint of the ALTA trial will be objective response rate (ORR) as measured by RECIST criteria. Secondary endpoints include time to response, duration of response, disease control rate, progression-free survival, overall survival, safety, and tolerability. Full patient enrollment in the ALTA trial is expected in the third quarter of 2015, and final data analysis will be performed when patients have completed six months of AP26113 treatment.

A copy of the press release is being filed herewith as Exhibit 99.1 and is incorporated by reference herein.

ITEM 9.01 Financial Statements and Exhibits

(d) The following exhibit is filed with this report:

Number  Description

99.1    Press Release dated March 24, 2014.

The press release contains hypertext links to information on our websites. The information on our websites is not incorporated by reference into this Current Report on Form 8-K and does not constitute a part of this Form 8-K.

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