If the news from Roche about Avastin failing in a phase III trial for gastric cancer wasn't enough this week, hot on it's heels was another alert today that Novelos Therapeutics just announced (pdf) that their phase III trial with NOV-002 in non-small cell lung cancer (NSCLC) was negative.
NOV-002 is a chemopotentiator and a chemoprotectant that works to try and enhance the effect of chemotherapy. It has been approved for use in Russia for the last decade and the early trial centres were Russian. Many of us were waiting to see what would happen in the larger scale phase III trial expected to be presented at AACR in April. It is only relatively recently that US centres have become involved, so anticipation in the product and company was beginning to build.
However, in a stunning press release, Novelos revealed this morning:
"The primary endpoint of improvement in overall survival was not met in Novelos’ pivotal Phase 3 trial in advanced non-small cell lung cancer (NSCLC) studying its lead product, NOV-002, in combination with first-line chemotherapy."
The trial involved 12 countries and enrolled 903 people with NSCLC. They were randomised to receive either standard chemotherapy (carboplatin plus paclitaxel) or chemotherapy plus NOV-002 with overall survival as the primary endpoint.
This endpoint was not met.
Data in breast cancer is due later this year, but it's probably not something to raise one's hopes about if the lung cancer data is anything to go by.
Promising phase II data does not always translate into positive phase III results in oncology; it's a big minefield fraught with as many failures as there are successes of late.