Pfizer has discontinued the SUN 1107 Phase III study of Sutent in advanced breast cancer based on statistical assessment for futility.
SUN 1107 evaluated single-agent sunitinib versus single-agent capecitabine for the treatment of a broad range of patients with advanced breast cancer after failure of standard treatment.
An independent Data Monitoring Committee found that even if the trial had been allowed to continue, treatment with single-agent sunitinib would be unable to demonstrate a statistically significant improvement in the primary endpoint of progression-free survival compared to single-agent capecitabine in the study population. Data from this trial are currently being analyzed.
Pfizer has notified clinical trial investigators involved in the study and regulatory agencies of these findings. The company is continuing to evaluate sunitinib as a single-agent and in combination with standard-of-care chemotherapy in specific patient populations with advanced breast cancer through three additional Phase III and two Phase II trials.
Pfizer is also continuing to study the role of sunitinib in the treatment of various other solid tumors including advanced non-small cell lung cancer, advanced colorectal cancer, advanced hepatocellular carcinoma and advanced hormone-refractory prostate cancer, in Phase III trials.
Mace Rothenberg, senior vice president of clinical development and medical affairs for oncology business unit at Pfizer, said: We are disappointed with these results given the previous findings that suggested sunitinib may provide benefit for patients with this difficult-to-treat cancer. In ongoing studies, we remain committed to evaluating sunitinib in advanced breast cancer and are continuing to study sunitinib in different populations and with different regimens.