Novartis’ Afinitor failed to meet goal in liver cancer

Novartis has reported that phase 3 clinical trial results show that Afinitor did not extend overall survival compared to placebo in patients with a specific form of liver cancer.

Afinitor (everolimus) was being investigated as a treatment for patients with locally advanced or metastatic hepatocellular carcinoma (HCC) after progression on or intolerance to sorafenib. Hepatocellular carcinoma, an aggressive and debilitating cancer, is the most common type of liver cancer.

Novartis has stated that it will not proceed with regulatory filings of Afinitor in this indication.

"While we are disappointed with these results, Novartis remains committed to studying everolimus through a robust research and development program to address unmet needs in different types of cancer. To date, Afinitor has proven efficacy in a number of tumor types, including hormone receptor positive advanced breast cancer, advanced pancreatic neuroendocrine tumors and advanced renal cell carcinoma."

Alessandro Riva, Global Head, Oncology Development & Medical Affairs, Novartis Oncology.

Afinitor has been approved in over 100 countries for various indications, including pancreatic cancer, advanced breast cancer and advanced renal cell carcinoma.

The results of this phase 3 liver cancer trial do not impact these worldwide approvals of Afinitor. Everolimus is also in phase 3 development in other diseases, including gastrointestinal and lung neuroendocrine tumors. Results of these trials are expected during 2014 and 2015.