Thursday, pharma giant Pfizer Inc. (PFE) announced the termination of a Phase 3 clinical trial examining the effects of investigational compound figitumumab with erlotinib as a second/third-line treatment in patients with non-small cell lung cancer, as the study failed to show any significant results of the desired end point. In addition, the company said its two Phase 3 studies of Sutent in advanced breast cancer also did not meet their primary endpoints.
The New York-based drug maker said it discontinued a Phase 3 trial of its lung cancer drug candidate on the recommendation of an independent data safety monitoring committee. The committee concluded that the addition of igitumumab to erlotinib as a second/third-line treatment in patients with non-small cell lung cancer, was unlikely to show a statistically significant improvement in the primary endpoint of overall survival compared to erlotinib alone in the study population.
Commenting on the decision, Mace Rothenberg, senior vice president of clinical development and medical affairs for Pfizer's Oncology Business Unit said, "This outcome is disappointing to us and to patients with NSCLC. Pfizer is working to thoroughly analyze all available data from the figitumumab program to better understand the compound and the IGF-1R pathway."
Earlier in December 2009, Pfizer terminated a Phase 3 trial examining the effects of investigational compound figitumumab as first-line treatment in patients with advanced non-adenocarcinoma non-small cell lung cancer due to the study meeting predefined boundaries for early termination.
The Phase 3 study was initiated based on findings from a Phase 2 study that identified patients of squamous cell histology, the most common form of non-adenocarcinoma and a disease with a high unmet medical need, as those who could benefit most from figitumumab treatment.
Pfizer Oncology has more than 25 biologics and small molecules in clinical development and more than 200 clinical trials underway.
Now, the company said that it has notified the clinical investigators and has initiated the notification procedure for all involved regulatory agencies of the discontinuation of the clinical trial. The company has also instructed the investigators to work with all of their patients in the A4021018 study on an individual basis to determine an appropriate course of action.
However, Pfizer said it would continue to study figitumumab in clinical trials for the potential treatment of prostate, breast and lung cancers, and Ewing's sarcoma.
"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," said Rothenberg.
Separately, Pfizer also revealed that two Phase 3 studies of Sutent in advanced breast cancer did not meet their primary endpoints. The Sutent clinical trial aimed at studying sunitinib in combination with docetaxel for the first-line treatment of patients with advanced HER-2 negative breast cancer. The company said the study did not show a statistically significant improvement in progression-free survival compared with docetaxel alone, as well as with capecitabine alone.
The company observed many serious adverse events during the clinical trial in he investigational arm than in the comparator arm of each study. A continuing analysis of efficacy and safety data will be completed and presented at a medical meeting in the near future.
Sutent is currently approved for both gastrointestinal stromal tumor after disease progression on or intolerance to imatinib mesylate, and advanced/metastatic renal cell carcinoma based on efficacy and safety data from large, randomized Phase 3 clinical trials.
Despite the termination of the clinical trial of the drug for treating breast cancer, Pfizer said it remains committed to the development program for sunitinib and is continuing to study its potential role in the treatment of other solid tumors including advanced non-small cell lung cancer, advanced castration-resistant prostate cancer, advanced hepatocellular carcinoma, and as adjuvant therapy for renal cell carcinoma in Phase 3 trials.
PFE closed Thursday's regular trading at $17.29, up $0.14 or 0.82%, on a volume of 49.13 million shares. However, the stock lost $0.07 or 0.40%, and traded at $17.20 in the after hours.
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