New drug brings hope to patients with rare cancers30 Sep 2015
Novartis has announced results of a Phase 3 pivotal study showing Afinitor® (everolimus) tablets reduced the risk of progression by 52% vs placebo in patients with advanced, progressive, nonfunctional neuroendocrine tumors of gastrointestinal or lung origin.
Neuroendocrine tumors are a rare type of cancer that originate in neuroendocrine cells found throughout the body, and are most often found in the gastrointestinal tract, lungs or pancreas. At time of diagnosis, 5%-44% of patients have advanced disease, meaning the cancer has spread to other parts of the body and is more difficult to treat.
Clinical results and safety profile of the drug
Everolimus is a mammalian target of rapamycin (mTOR) inhibitor. The data from the RADIANT-4 study show that the drug:
- Extended median progression free survival by 7.1 months as median progression free survival by central review was 11.0 months in the everolimus arm and 3.9 months in the placebo arm.
- While the overall survival data are not mature, the first interim analysis showed a trend favoring the everolimus arm.
- As for the 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.
Safety was also a secondary endpoint of the trial and adverse events were consistent with the known safety profile of everolimus. The most common treatment-related grade 3/4 adverse events for everolimus and placebo, respectively, were stomatitis, diarrhea and infections.
A new clinically meaningful therapy for a rare and aggressive cancer type
"Advanced, progressive, nonfunctional neuroendocrine tumors of gastrointestinal or lung origin are rare and aggressive cancers, with limited treatment options," said James Yao, MD, Professor of Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, and the study's principal investigator. "These pivotal trial results demonstrate strong evidence for the efficacy of the mTOR inhibitor everolimus in this patient population."
"These results show that everolimus has the potential to be a new, clinically meaningful therapy for patients with advanced, progressive, nonfunctional neuroendocrine tumors of gastrointestinal or lung origin, which typically have poor prognoses," said Alessandro Riva, MD, Global Head, Novartis Oncology Development and Medical Affairs.
Source: Medical News Today