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news.Antisoma has announced that its partner Novartis has started the pivotal Phase III trial of ASA404 combined with first-line chemotherapy in non-small cell lung cancer.
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The Attract-1 trial is a randomized, double-blind, placebo-controlled, multicentre Phase III trial being conducted across the US, EU and other territories. With 1200 patients, it will be amongst the largest trials conducted in non-small cell lung cancer (NSCLC).
Attract-1 is open to patients with all histologies, or types, of NSCLC, including squamous and non-squamous cancers. Patients are being randomized 1:1 to receive either ASA404 1800 mg/m2 plus chemotherapy (carboplatin/paclitaxel) or a placebo plus chemotherapy (carboplatin/paclitaxel) as a control. The primary endpoint of the Attract-1 trial is overall survival. Key secondary endpoints are survival in the squamous and non-squamous patient subgroups.
The Attract-1 study is designed to support applications for marketing authorizations in the US, Europe and other territories. Its initiation triggers a $25 million milestone payment to Antisoma. If the trial results are positive, applications for marketing authorizations are anticipated in 2011. There will be a single scheduled interim look during the trial, expected in mid-late 2009.