Novelos’ Phase 3 Lung Cancer Trial Fails To Meet Primary Endpoint

The randomised, 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.

Reportedly, 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.

Harry Palmin, president and CEO of Novelos, said: “We are very disappointed that our pivotal Phase 3 lung cancer trial did not meet the primary survival endpoint. 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.”