This morning I did a double take at an email alert that flashed through my email:
"ATTRACT-1 phase III trial of ASA404 halted following interim analysis"
Ugh, that's not good news considering the phase II data previously discussed in January looked very promising with a solid improvement (source data), ie median time to tumor progression was 5.5 months by investigator assessment and median survival was 14.9 months when used in combination with carboplatin-paclitaxel compared to the standard alone.
"The planned interim analysis of data from the ATTRACT-1 phase III trial of ASA404 in previously untreated non-small cell lung cancer (NSCLC) has shown that continuation of the trial would be futile, as there is little or no prospect of demonstrating a survival benefit with ASA404 in this setting. The ATTRACT-1 trial will therefore be halted."
Novartis (a client, but not on this particular agent) bought the global rights to ASA404 (vadimezan) from Antisoma, a British company, approximately three years ago. ASA404 was leading a new class of chemotherapy agents known as vascular targeting or disrupting agents, designed to inhibit angiogenesis and disrupt the flow of blood to tumours. The concept works in a different way to Roche and Genentech's bevacizumab (Avastin), which starves tumours from growing new blood vessels and proliferating the cancer mass. ASA404 exerts direct and indirect effects on endothelial cells rather than the VEGF receptor, as this diagram shows:
Source: Novartis Oncology
Novartis and Antisoma were also developing ASA404 in breast cancer as well as non-small cell lung cancer, so we'll have to wait and see what happens to that program going forward. For now, the negative news in lung cancer meant that investors cleared out their shares, sending the stock into a major freefall this morning.
It's been a tough year for cancer drugs in lung cancer in 2010 already, following several spectacular rounds of futile data from Pfizer's figitimumab, Novelos's NOV-002 and now ASA404, all of which had promising but early data in phase II, only to stumble in phase III.