Pfizer has discontinued the SUN 1170 Phase III study of Sutent (sunitinib malate) in advanced hepatocellular carcinoma (HCC), or liver cancer. The decision follows a review by the independent Data Monitoring Committee (DMC) that showed a higher incidence of serious adverse events in the sunitinib arm compared to the sorafenib arm. Also, sunitinib did not demonstrate that it was either superior or non-inferior to sorafenib in the survival of patients with advanced liver cancer. No new or unexpected serious adverse events were observed in the trial.
“There is a great need for effective new therapies for patients with advanced liver cancer. The disappointing outcome of this trial challenges all of us to work harder to understand the complex biology of this disease. The result of this trial in hepatocellular cancer patients does not diminish our confidence in Sutent for the treatment of patients with renal cell cancer and GIST. We are committed to patient safety and are working with investigators to better understand these trial results and their implications for clinical practice,” said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs for Pfizer’s Oncology Business Unit. “We continue to study the potential role of Sutent in the treatment of various types of cancer in late-stage trials.”
Sunitinib is currently approved for both gastrointestinal stromal tumors (GIST) after disease progression or intolerance to imatinib mesylate, and advanced/metastatic renal cell carcinoma (RCC).