Everolimus to cover unmet health care need

28 Oct 2015

The agent everolimus showed real promise in treating patients with nonfunctional neuroendocrine tumors of lung or gastrointestinal origin, a new study reveals. Everolimus is already approved for treating advanced neuroendocrine tumors (NET) of the pancreas. Up until now no suitable data has been available about the use of everolimus this condition.

Everolimus is an agent that blocks the mTOR receptor in the cell interior. MTOR (mammalian target of rapamycin) is an enzyme that controls cell survival, growth, division and mobility. It is part of the signaling system in the body and the start of a cascade of signaling pathways.

Over activity of these signaling pathways can contribute significantly to the development and progression of certain types of cancer, such as advanced, nonfunctional neuroendocrine tumors, for example. If mTOR is inhibited, tumor growth is slowed down.


Clinical findings proving the efficacy and safety of the agent

The RADIANT-4 study investigated the efficacy and safety of everolimus for nonfunctional neuroendocrine tumors of lung or gastrointestinal origin. The study was the first large-scale, international, placebo-controlled, phase 3 study conducted with patients with advanced, nonfunctional neuroendocrine tumors to investigate the use of everolimus in this patient population. 302 patients were enrolled in the study. Their average age was 63 and 53% of participants were women.

In particular, the results revealed that:

  • Progression-free survival of patients was successfully extended by seven months
  • The risk of progression of the disease fell by 52%.
  • Everolimus was well tolerated
  • Side-effects were consistent with the known profile.

“There is no properly established treatment option for this condition”

Markus Raderer, oncologist at the University Department of Internal Medicine I at MedUni Vienna and Vienna General Hospital, Deputy Director of the CCC unit for NeuroEndocrine Tumors (CCC-NET) and co-author of the study, says: "So far, treatment options have been very limited, especially for NET of the lung. The results of our approval study show that the period of progression-free survival can be extended by 7.1 months compared with placebo and the risk of progression of the disease can be reduced by 52%.”

“Since everolimus is also known to be safe, it can potentially be used effectively in everyday clinical practice. Especially for NET of the lung, I believe this represents major therapeutic progress, because, hitherto, there has not been any properly established treatment option for this condition", he added. 

Source: Medical News Today

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