Pfizer discontinues Ph III trial of Sutent in advanced liver cancer as it fails versus Bayer's Nexavar

In another setback to extend the indications of its cancer drug Sutent (sunitinib), global drug behemoth Pfizer has announced the discontinuation of the SUN 1170 Phase III open-label study of the compound in advanced hepatocellular carcinoma (HCC), or liver cancer.

Only last month the company revealed that two Phase III studies of Sutent - which generated sales of $964 million in its current indication last year ' in advanced breast cancer did not meet their primary endpoints (The Pharma Letter March 12).
Sutent also failed to achieve positive results in tests against Roche's Xeloda (capecitabine) in breast cancer and Avastin (bevacizumab) in combination with Bristol-Myers Squibb's Taxol (paclitaxel)and versus placebo in combination with Sanofi-Aventis' Taxotere (docetaxel), as well as another testing it when combined with Xeloda.

Following a review by the independent Data Monitoring Committee (DMC), the liver cancer study was discontinued based on a higher incidence of serious adverse events in the sunitinib arm compared to the sorafenib (German drug major Bayer's Nexavar) arm and the fact that sunitinib did not meet the criteria to demonstrate that it was either superior or non-inferior to sorafenib in the survival of patients with advanced hepatocellular cancer. No new or unexpected types of serious adverse events were observed in the SUN 1170 trial.