Novartis, Basel, Switzerland, has announced that its ASA404 has entered a Phase III trial for the treatment of lung cancer. This follows positive outcomes of a Phase II trial for the novel cancer agent.
ASA404 is a tumor-vascular disrupting agent that selectively collapses the blood supply to existing tumors, leading to tumor-cell death. ASA404 attacks the blood vessels that tumors rely on to survive and grow. This method of cancer treatment is different from angiogenesis inhibitors, which restrain the formation of new tumor blood vessels, instead of attacking existing blood vessels.
The study, called ATTRACT-1 (Antivascular Targeted Therapy: Researching ASA404 in Cancer Treatment), will include 1,200 patients on 200 sites in 20 different countries.
The Phase III trial will be randomized, double blind, and placebo controlled. The study will use ASA404 in combination with paclitaxel and carboplatin as a first-line treatment for locally advanced or metastatic NSCLC.
In the randomized Phase II study, ASA404 combined with chemotherapy showed a median overall survival advantage of more than 5 months in first-line treatment of advanced non-small cell lung cancer (NSCLC) compared to chemotherapy alone. Non-small cell lung cancer accounts for about 85% to 90% of all lung cancers.