Pfizer has shut down a phase III trial of figitumumab, a promising investigational compound for treatment of late stage non-small cell lung cancer (NSCLC), because of excess deaths in the experimental treatment arm.
In an announcement issued December 29, the company said the study met "predefined boundaries for early termination."
The trial had randomized patients with advanced non-adenocarcinoma NSCLC to figitumumab on top of standard therapy with paclitaxel and carboplatin, or to standard therapy alone.
The announcement was not unexpected. It followed a decision last September to stop enrolling new patients in the trial because of safety concerns revealed in an analysis by the independent Data Safety Monitoring Committee.
"While these findings are disappointing, Pfizer is committed to using information gained from this study to refine the design of future trials of figitumumab in non-small cell lung cancer," said Mace Rothenberg, MD, senior vice president of clinical development and medical affairs for Pfizer's Oncology Business Unit, in the company statement.
"We are hopeful that we will be able to identify a subset of patients who may have derived benefit from the addition of figitumumab to chemotherapy," Rothenberg said in the statement. "If this can be done, then future trials will focus on this group of patients in our efforts to deliver this drug to the right patient."
The company is continuing its figitumumab clinical trial program with a phase III trial of the drug in combination with erlotinib versus erlotinib alone for treatment of patients with refractory advanced non-adenocarcinoma NSCLC and a trial that will evaluate figitumumab in combination with cisplatin and gemcitabine for first line treatment of advanced NSCLC.
In addition to NSCLC, the company said it is studying figitumumab in clinical trials for the potential treatment of other cancers, including prostate and breast cancers, and Ewing's sarcoma.