Afinitor fails to meet survival endpoint for liver cancer indication

A global phase 3 study of everolimus as a treatment for patients with advanced liver cancer did not improve survival among users compared with placebo recipients, according to a press release.

Everolimus (Afinitor, Novartis) is currently approved in the United States and Europe to treat advanced renal cell carcinoma, progressive neuroendocrine tumors with pancreatic origin and postmenopausal women with HER-2-negative advanced breast cancer.

In the double-blind Everolimus for Liver Cancer Evaluation-1 (EVOLVE-1) study, researchers randomly assigned 546 patients at a 2:1 ratio to 7.5 mg oral everolimus daily, or placebo, in addition to standard care. All participants had locally advanced or metastatic HCC and were either intolerant to sorafenib or experienced disease progression while taking it. Overall survival was the primary endpoint, with other evaluated factors including safety, quality of life, disease control rate, and time to performance status deterioration and tumor progression.

Afinitor did not provide a survival benefit among recipients compared with placebo patients, and the company will not proceed with regulatory filings for the indication of advanced liver cancer. The results remain under evaluation, and will be presented at a future conference, according to the release.

The EVOLVE-1 results will not affect existing approvals for other indications, and results from phase 3 trials for other indications, including gastrointestinal and lung neuroendocrine tumors, lymphoma and breast cancer, are expected in 2014 and 2015.

“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,” Alessandro Riva, MD, global head of the oncology department and medical affairs for Novartis Oncology, said in the release.

A global phase 3 study of everolimus as a treatment for patients with advanced liver cancer did not improve survival among users compared with placebo recipients, according to a press release.

Everolimus (Afinitor, Novartis) is currently approved in the United States and Europe to treat advanced renal cell carcinoma, progressive neuroendocrine tumors with pancreatic origin and postmenopausal women with HER-2-negative advanced breast cancer.

In the double-blind Everolimus for Liver Cancer Evaluation-1 (EVOLVE-1) study, researchers randomly assigned 546 patients at a 2:1 ratio to 7.5 mg oral everolimus daily, or placebo, in addition to standard care. All participants had locally advanced or metastatic HCC and were either intolerant to sorafenib or experienced disease progression while taking it. Overall survival was the primary endpoint, with other evaluated factors including safety, quality of life, disease control rate, and time to performance status deterioration and tumor progression.

Afinitor did not provide a survival benefit among recipients compared with placebo patients, and the company will not proceed with regulatory filings for the indication of advanced liver cancer. The results remain under evaluation, and will be presented at a future conference, according to the release.

The EVOLVE-1 results will not affect existing approvals for other indications, and results from phase 3 trials for other indications, including gastrointestinal and lung neuroendocrine tumors, lymphoma and breast cancer, are expected in 2014 and 2015.

“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,” Alessandro Riva, MD, global head of the oncology department and medical affairs for Novartis Oncology, said in the release.