Pfizer Stops Breast Cancer Study
Jacksonville – This past Thursday, Pfizer Inc. announced it is stopping once clinical trial of the company’s drug, Sutent. The drug was being developed to target advanced breast cancer.
Compared to chemotherapy drug capecitabine (Xeloda by Roche), Pfizer reported no measurable benefit to Sutent during the Phase III trial–which is required by the Food and Drug Administration for drug approval. There are still five other studies being conducted on Sutent, says Pfizer.
The study, involving 455 patients diagnosed with advanced breast cancer, followed patients’ responses depending on whether they were assigned to take Sutent or Xeloda. These specific patients had previously failed treatment with alternate drug therapy.
Per Pfizer, independent analysis reported that treatment with Sutent would not be able to produce a statistically significant advantage versus Xeloda in progression-free survival, the point at which a tumor begins to grow again. Based on this, they recommended the study be stopped.
Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs for Pfizer’s Oncology Business Unit, expressed his disappointment with the news, stating, “We are disappointed with these results given the previous findings that suggested [Sutent] may provide benefit for patients with this difficult-to-treat cancer.” He expresses hope, however, saying, “…we remain committed to evaluating [Sutent] in advanced breast cancer and are continuing to study [Sutent] in different populations and with different regimens.”
In fact, last year, the targeted cancer drug brought Pfizer nearly $847 million, making it the company’s best-selling cancer drug. Sutent, which is taken orally, works by attacking a specific protein responsible for the rapid growth of tumors via developing blood vessels. Its benefit is that the drug only targets cancer cells, and spares the patient’s healthy cells–this is an advantage to chemotherapy.
Last month, Pfizer announced a successful Phase III study demonstrating Sutent’s effects against pancreatic cancer. The drug was shown to slow progression of a rare form of the severe cancer.
Options are still on the horizon, says Pfizer. They are conducting three additional Phase III studies and two Phase II studies evaluating Sutent and its use in breast cancer. These studies involve evaluating the combined use of Sutent and Xeloda, and other chemotherapeutic drugs. The effects are compared to patients who are undergoing treatment with another Roche drug, Avastin.
Sutent is currently FDA approved as treatment for gastrointestinal cancer and kidney cancer. It is also being studied for its effects on other types of cancer, including non-small cell lung cancer, advanced colon cancer, liver cancer and prostate cancer.
