NEW YORK March 11, 2010 (cancerfacts.com) Pfizer Inc. announced today it is suspending a large clinical trial of its lung-cancer drug figitumumab in patients with previously treated advanced non-small cell lung cancer (NSCLC) on the recommendation of the study’s independent Data Safety Monitoring Committee. Pfizer had been testing figitumumab in combination with erlotinib (Tarceva®) as a second and third-line treatment in patients with non-adenocarcinoma non-small cell lung cancer. the committee recommended the trial be stopped after concluding that the addition of figitumumab to erlotinib is unlikely to demonstrate a statistically significant improvement in the primary endpoint of overall survival compared to erlotinib alone in the study population. “This outcome is disappointing to us and to patients with non-small cell lung cancer. Pfizer is working to thoroughly analyze all available data from the figitumumab program to better know the compound and the IGF-1R (insulin growth factor-1 receptor) pathway,” said Dr. Mace Rothenberg, senior vice president of clinical development and medical affairs for Pfizer’s Oncology Business Unit. “As a pioneer in the IGF-1R field, we are committed to a thorough evaluation of figitumumab. We will carefully review our extensive clinical database and use this information to refine the figitumumab clinical program with the goal of identifying the right patient population in which to evaluate this compound.” The Company has told the clinical investigators conducting the trial and has initiated the notification procedure for all involved regulatory agencies of the discontinuation of the trial. Investigators have been instructed to work with all of their patients participating to determine an appropriate course of action. Figitumumab is an investigational fully human monoclonal antibody that binds to the insulin growth factor-1 receptor (IGF-1R), which plays a key role in one of the fundamental signaling pathways that leads to uncontrolled growth and survival of tumor cells. Figitumumab is thought to represent an alternative to tumors that develop resistance to EGFR inhibitors like Tarceva and other anti-cancer therapies. This is the second major trial in non-small cell lung cancer patients that has been stopped because the addition of figitumumab was unlikely to increase survival. in December 2009, Pfizer announced the stopping the ADVIGO 1016 trial, that was examining the effects of figitumumab in combination with carboplatin and paclitaxel as first-line treatment in patients with advanced non-adenocarcinoma NSCLC. in that study the committee also found that the addition of figitumumab to carboplatin plus paclitaxel would be unlikely to improve overall survival compared to paclitaxel plus carboplatin alone. Pfizer is continuing to study figitumumab in clinical trials for the potential treatment of prostate and breast cancers, along with Ewing’s sarcoma and other types of lung cancers. Lung cancer is the most common cancer worldwide. NSCLC accounts for about 85 percent of lung cancer cases and 25 to 30 percent are of squamous histology. nearly 60 percent of NSCLC patients are diagnosed late with Stage IIIB/IV advanced disease. Despite recent advances, NSCLC remains hard to treat, particularly in the metastatic setting. SOURCE: adapted from press materials provided by Pfizer, Inc.