Study shows Novartis’s Afinitor positively reduces tumors
pharmafile | September 30, 2015 | News story | Research and Development | Afinitor, Novartis
Novartis has announced the results of a Phase III pivotal study, showing Afinitor (everolimus) tablets reduced the risk of progression by 52% in comparison to its placebo in patients with advanced, progressive, nonfunctional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin.
Additionally, the data from the Radiant-4 trial shows everolimus, a mammalian target of rapamycin (mTOR) inhibitor, extended median progression free survival by 7.1 months. Overall survival (OS) was a key secondary endpoint of the study, where the first interim analysis showed a trend favouring the everolimus arm.
Another secondary endpoint was best overall response rate; the study found that 64% of patients receiving everolimus experienced at least some degree of tumor shrinkage compared to 26% of those on placebo.
James Yao, the study’s principal investigator and professor of medicine at The University of Texas MD Anderson Cancer Center, Houston, Texas says: “Advanced, progressive, nonfunctional NET of GI or lung origin are rare and aggressive cancers, with limited treatment options. These pivotal trial results demonstrate strong evidence for the efficacy of the mTOR inhibitor everolimus in this patient population.”
NET is a rare type of cancer that originates in neuroendocrine cells which can be found throughout the body, and are most often found in the GI tract, lungs or pancreas. NET can be functional or nonfunctional: functional NET produce symptoms caused by the secretion of hormones and other substances; nonfunctional NET may produce symptoms caused by the tumor’s growth, such as intestinal blockage, pain and bleeding.
Alessandro Riva, global head, Novartis Oncology Development and Medical Affairs, adds: “These results show that everolimus has the potential to be a new, clinically meaningful therapy for patients with advanced, progressive, nonfunctional GI or lung NET, which typically have poor prognoses.
“Our work with the Radiant clinical program demonstrates our long-term commitment to NET and has yielded important data that have led to improved outcomes for patients with different types of NET.”
The results of the Radiant-4 study-part of the largest clinical trial program in patients with advanced NET will serve as the basis of worldwide regulatory submissions for Afinitor for the treatment of advanced, progressive, nonfunctional GI and lung NET.
Afinitor is already approved in more than 95 countries worldwide for locally advanced, metastatic or unresectable progressive NET of pancreatic origin.
Yasmita Kumar
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