Novelos Therapeutics' NOV-002 Phase 3 NSCLC trial fails to meet primary survival endpoint

Novelos Therapeutics, Inc. (OTCBB: NVLT), a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, today announced that 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. Detailed trial results are expected to be presented via appropriate scientific venue later this year.

“We are very disappointed that our pivotal Phase 3 lung cancer trial did not meet the primary survival endpoint”

This randomized, controlled, open-label Phase 3 trial, conducted under a Special Protocol Assessment (SPA) and Fast Track designation, had enrolled 903 patients with Stage IIIb/IV NSCLC, which includes all histological subtypes. The trial, conducted across approximately 100 clinical sites in 12 countries, evaluated NOV-002 in combination with first-line paclitaxel and carboplatin chemotherapy versus paclitaxel and carboplatin alone. The primary efficacy endpoint of the trial was improvement in overall survival. Enrollment commenced in November 2006, target enrollment was achieved in March 2008, and the 725 event (patient death) was announced in early January 2010. According to the trial’s Statistical Analysis Plan (SAP), a total of 725 events were required to detect a 25% improvement (12.5 months versus 10 months) in overall median survival (hazard ratio of 0.8) with 85% power and a two-sided significance level of 0.05. No interim analysis was performed.

“We are very disappointed that our pivotal Phase 3 lung cancer trial did not meet the primary survival endpoint,” said Harry Palmin, President and CEO of Novelos. “We were hopeful of a positive outcome based on our statistical model simulations and stated assumptions. In retrospect, it appears our simulations were inaccurate due to trial data deviating from our statistical model, the impact of censoring patterns, and control arm survival exceeding our expectations based on historical precedents. We will conduct a thorough analysis of all the data, and expect to present detailed Phase 3 lung cancer trial results later this year. Meanwhile, we are scheduled to present new NOV-002 preclinical data at the AACR Annual Meeting in April 2010, and we are on track for results from a NOV-002 Phase 2 breast cancer trial in 3Q 2010. We are also on track to initiate a Phase 2 hepatitis C trial shortly, with our second compound NOV-205.”