Antisoma announces start of phase III lung cancer trial of ASA404

Initiation triggers USD 25 million milestone payment from Novartis

14-Apr-2008

Antisoma plc 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 (NSCLC). The study, called ATTRACT-1, is designed to support applications for marketing authorisations in the US, Europe and other territories. Its initiation triggers a USD 25 million milestone payment to Antisoma.

Glyn Edwards, Antisoma's CEO, said: "We're delighted that the phase III trial in lung cancer is underway, putting ASA404 on a clear path towards potential marketing applications. Lung cancer is an indication with substantial unmet clinical need and blockbuster sales potential, and Novartis' trial is optimally designed to seek confirmation of the positive results seen in our two phase II lung cancer studies."

The ATTRACT-1 trial is a randomised, 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 NSCLC. ATTRACT-1 is open to patients with all histologies, or types, of NSCLC, including squamous and non-squamous cancers. Patients are being randomised 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.

If the trial results are positive, applications for marketing authorisations are anticipated in 2011. There will be a single scheduled interim look during the trial, expected in mid-late 2009.

https://www.bionity.com/en/news/80741/antisoma-announces-start-of-phase-iii-lung-cancer-trial-of-asa404.html