Pfizer halts late-stage trial of Sutent in liver cancer due to safety issues

Pfizer announced that it discontinued a late-stage study of Sutent (sunitinib) as a treatment for patients with advanced hepatocellular carcinoma. The company said an independent data monitoring committee found that there were more serious adverse events in patients receiving the drug than those taking Bayer and Onyx Pharmaceuticals' Nexavar (sorafenib) as part of the SUN 1170 trial.

In addition, the drugmaker noted that Sutent failed to demonstrate that "it was either superior or non-inferior" to Nexavar in extending the survival of patients in the study. Mace Rothenberg, head of clinical development for Pfizer's oncology unit, called the data a "disappointing outcome," adding that the company is "working with investigators to better understand these trial results and their implications for clinical practice."

Sutent, which is approved to treat advanced kidney cancer and gastrointestinal stromal tumours, recently also failed to meet the endpoints of Phase III studies in both colorectal cancer and breast cancer. Pfizer is also studying the drug in late-stage studies involving patients with non-small-cell lung cancer, prostate cancer and for kidney cancer following surgery.

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