On September 15, 2015 ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) reported that it has achieved full enrollment in the pivotal Phase 2 ALTA trial of its investigational anaplastic lymphoma kinase (ALK) inhibitor, brigatinib (Press release, Ariad, SEP 15, 2015, View Source [SID:1234507472]). This registration study enrolled approximately 220 patients at approximately 75 sites in North America, Europe and Asia. Schedule your 30 min Free 1stOncology Demo! "We are proud to have completed patient enrollment in the ALTA trial in the timeframe we established at the outset," stated Timothy P. Clackson, president of research and development and chief scientific officer of ARIAD. "We expect data from this trial to form the basis for an NDA filing of brigatinib in patients with refractory non-small cell lung cancer in the third quarter of next year."
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The ALTA (ALK in Lung Cancer Trial of AP26113) trial is designed to determine the safety and efficacy of brigatinib (previously known as AP26113) in refractory non-small cell lung cancer (NSCLC) patients who test positive for the ALK oncogene (ALK+) and who have been treated with and progressed on their most recent crizotinib therapy. The primary endpoint of the trial is objective response rate (ORR) as measured by RECIST criteria. Brigatinib received Breakthrough Therapy designation from the U.S. Food and Drug Administration in 2014.
Median time on treatment for patients in the ALTA trial is less than 4 months, and follow-up data are limited at this time. As a result, ARIAD now expects that first data from the trial will be submitted for presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in 2016. Presenting data at ASCO (Free ASCO Whitepaper) will also align more closely with the anticipated filing for marketing approval of brigatinib in the U.S. in the third quarter of 2016.
A randomized front-line clinical trial of brigatinib is expected begin in early 2016. This Phase 3 trial will compare brigatinib to crizotinib in approximately 300 patients with ALK+ NSCLC, who have not received prior ALK inhibitors.
About Brigatinib
Brigatinib (AP26113) is an investigational, targeted cancer medicine discovered internally at ARIAD Pharmaceuticals, Inc. It is in development for the treatment of patients with ALK+ NSCLC that is resistant to crizotinib. Brigatinib received Breakthrough Therapy designation from the FDA in October 2014 on the basis of an ongoing Phase 1/2 trial. Brigatinib is currently being evaluated in the global Phase 2 ALTA trial that is anticipated to form the basis for its initial regulatory review.