In a major setback for the company, Pfizer (PFE) has had to discontinue a final stage study. It was evaluating the effectiveness of a combination of an investigational compound figitumumab with erlotinib for the second/third-line treatment in previously treated patients for non-small cell lung cancer (NSCLC).
The decision to discontinue the study was taken following the recommendation from an independent Data Safety Monitoring Committee (DSMC). The committee was of the opinion that the addition of figitumumab to erlotinib is unlikely to demonstrate any improvement with respect to the overall survival of a patient compared to the treatment with only erlotinib.
This is not the first setback for figitumumab. In December 2009, Pfizer had to stop a phase III study of the drug as a first-line treatment in NSCLC patients. The DSMC recommended that the addition of figitumumab to carboplatin and paclitaxel was not likely to improve the overall survival compared to treating with paclitaxel and carboplatin.
However, the company is continuing to study figitumumab for the treatment of prostate and breast cancer.
Pfizer also suffered another setback on two phase III studies of Sutent in advanced breast cancer. The company was evaluating Sutent in combination with docetaxel as a first-line treatment of patients with advanced HER-2 negative breast cancer. However, the study failed to show any improvement in progression-free survival compared with docetaxel alone.
In the second study, Sutent was evaluated with capecitabine in previously treated advanced breast cancer patients. This study also failed to show any significant improvement in progression-free survival compared with capecitabine alone.
Sutent received approval from the US food and Drug Administration (FDA) in January 2006 for the treatment of gastrointestinal stromal tumors (GIST) and metastatic renal cell carcinoma (RCC). The drug has experienced very strong uptake, ending 2009 with revenues up 14% at $964 million.
The biggest concern being faced by Pfizer is the slated patent expiry of its highest selling drug, Lipitor. Given the scenario, Pfizer’s pipeline must deliver to recoup some of the lost sales of Lipitor.
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