Antisoma starts Ph III NSCLC trial, earns $25M

Antisoma has started a pivotal Phase III trial of ASA404 combined with first-line chemotherapy in non-small cell lung cancer, triggering a $25.0-million payment from development partner, Swiss drug major Novartis. On the day the ATTRACT-1 study was initiated, April 11, shares in the UK cancer specialist jumped 12% to L0.28.

Last year, at the World Conference on Lung Cancer in Seoul, South Korea, Antisoma presented encouraging data on ASA404 from a single-arm Phase II trial (Marketletter September 17, 2007). NSCLC patients on a 1,800mg/m2 dose of the tumor vascular-disrupting agent in combination with carboplatin and paclitaxel chemotherapy showed a median survival of 14.9 months, with an average time-to-disease progression of 5.5 months and an overall tumor response rate of 37.9%.

The randomized, double-blind, placebo-controlled, 1,200-patient, ATTRACT-1 trial, which is being conducted across the USA, European Union and other territories, is open to patients with all types of NSCLC, including squamous and non-squamous cancers. The primary endpoint of the study is overall survival. If the 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, noted the UK firm.