Novelos Therapeutics Reaches 725th Event In Pivotal Phase 3 Lung Cancer Trial

Main Category: Lung Cancer
Also Included In: Cancer / Oncology;  Clinical Trials / Drug Trials
Article Date: 11 Jan 2010 - 3:00 PDT

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Novelos Therapeutics, Inc. (OTCBB: NVLT), a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, today announced that the 725th event (patient death) has been reached in its 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 725th event triggers the steps towards the pre-specified analysis according to the trial's Statistical Analysis Plan (SAP). Top-line trial results are expected to be available later in the first quarter.

This randomized, controlled, open-label Phase 3 trial, being conducted under a Special Protocol Assessment (SPA) and Fast Track designation, has enrolled 903 patients with Stage IIIb/IV NSCLC, which includes all histological subtypes. The trial, conducted across approximately 100 clinical sites in 12 countries, is evaluating NOV-002 in combination with first-line paclitaxel and carboplatin chemotherapy versus paclitaxel and carboplatin alone. The primary efficacy endpoint of the trial is improvement in overall survival. Enrollment commenced in November 2006 and the target enrollment was achieved in March 2008. According to the SAP, a total of 725 events are required to detect a 25% improvement in overall 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 on track for our pivotal Phase 3 trial to conclude this quarter," said Harry Palmin, President and CEO of Novelos. "Should this registrational trial be positive, we will proceed with filing a New Drug Application (NDA) in 3Q 2010. Thereafter, based on our Fast Track designation, we would project FDA approval for first-line treatment of advanced NSCLC in combination with chemotherapy in 1Q 2011."

About NSCLC

NSCLC accounts for about 87% of lung cancer, which is the leading cause of cancer death in the U.S. According to the American Cancer Society, approximately 215,000 people were expected to be diagnosed with lung cancer in 2008 in the U.S., with approximately 162,000 deaths. Approximately 1,500,000 new cases of lung cancer were expected worldwide in 2007 and approximately 1,350,000 deaths were projected from lung cancer in 2007. Only about 16% of NSCLC patients are diagnosed early enough to be eligible for surgery. Platinum-based chemotherapy regimens are standard first-line treatment for advanced NSCLC patients. Paclitaxel and carboplatin is the most common first-line treatment in the U.S., while gemcitabine / pemetrexed and cisplatin are more common in Europe. During treatment, patients are subject to serious chemotherapy-induced adverse effects. According to results of 12 Phase 3 clinical trials published from 2001-2008, the one-year survival rate for patients receiving paclitaxel and carboplatin first-line therapy was on average only about 40%, the weighted average for median survival was 9.7 months and the objective tumor response (defined as greater than 30% tumor shrinkage) rate was about 27%. Overall, fewer than 5% of advanced non-small cell lung cancer patients survive five years.

About NOV-002 for NSCLC

NOV-002 is a small molecule compound based on a proprietary formulation of oxidized glutathione that acts together with chemotherapy as a chemopotentiator and a chemoprotectant by regulating redox-sensitive cell signaling pathways. Three separate Phase 2 trials demonstrated clinical activity and safety of NOV-002 in combination with first-line chemotherapy in NSCLC. In a controlled, randomized U.S. Phase 1/2 clinical trial, advanced NSCLC patients treated with NOV-002 in combination with first-line paclitaxel and carboplatin demonstrated improved objective tumor response (p<0.05) and higher tolerance of chemotherapy (p<0.01) compared to the active control group. In a controlled, randomized Russian Phase 2 trial, when used in combination with cisplatin-based first-line chemotherapy, NOV-002 increased the one-year survival of advanced NSCLC patients from 17% to 63% (p<0.01); median survival (i.e. 50% of patients dead) was not reached in the NOV-002 arm at 14 months compared to a median survival of 7 months in the active control. In a single arm Russian Phase 2 trial, advanced NSCLC patients treated with NOV-002 in combination with first-line cisplatin-based chemotherapy exhibited greater than 50% one-year survival. NOV-002 has an extensive safety database, and has also demonstrated improved recovery from chemotherapy toxicity in cancer patients. Importantly, NOV-002 does not appear to be chemotherapy specific or tumor specific.

Source
Novelos Therapeutics, Inc.

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