Antisoma's ASA404 enters pivotal phase III trial in second-line lung cancer
Antisoma plc announced that 'ATTRACT-2', a phase III trial testing ASA404 as a second-line treatment for non-small cell lung cancer (NSCLC), is now underway. This is a single pivotal study designed to support applications to market ASA404 for lung cancer patients who have received one previous round of treatment. A separate, ongoing pivotal trial, ATTRACT-1, is evaluating ASA404 in patients receiving their first treatment for NSCLC.
ATTRACT-2 (Anti-vascular Targeted Therapy: Researching ASA404 in Cancer Treatment-2) is a randomised, double-blind, placebo-controlled, multi-centre, multi-country phase III trial that will include approximately 900 patients receiving their second treatment for stage IIIb/IV NSCLC of either squamous or non-squamous histology. It is open to patients who previously received only chemotherapy and to patients who received chemotherapy plus bevacizumab or cetuximab as their first-line treatment. Patients will be randomly assigned to receive either ASA404 1800 mg/m2 plus docetaxel or a placebo plus docetaxel. The primary endpoint of the trial is overall survival. Before the final analysis there will be a single interim look, which is expected to occur during 2010. The study is expected to be completed in 2011.
ASA404 (DMXAA) is a small-molecule Tumour-Vascular Disrupting Agent (Tumour-VDA) which selectively targets the blood vessels that nourish tumours. The drug was discovered by Professors Bruce Baguley and William Denny and their teams at the Auckland Cancer Society Research Centre, University of Auckland, New Zealand. It was in-licensed by Antisoma from Cancer Research Ventures Limited (now Cancer Research Technology), the development and commercialisation company of the Cancer Research Campaign (now Cancer Research UK), in August 2001. Worldwide rights to the drug were licensed to Novartis AG in April 2007.
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