Gastric cancer is a disease in which cancer cells form in the lining of the stomach. Almost all gastric cancers are adenocarcinomas, a cancer that begins in glandular tissue. Gastric cancer is often in an advanced stage when it is diagnosed. At this stage, it can often be treated, but rarely cured.
When diagnosed at a late stage, gastric cancer is typically un-resectable and/or metastatic.
The incidence rate is higher in Asia, as exemplified by Japan where the incidence rate is five times that of the US and Europe.
The gastric cancer drug market is growing rapidly and is expected to exceed USD 4 billion by 2022 according to GlobalData. This growth is fuelled by several factors, including an increase in the overall incidence as well as increase in treatment rates and extended treatment duration.
There are several chemotherapeutic drugs on the market, and one well-established and effective molecule is irinotecan. It has a proven anti-tumor effect and is approved for combination use in several solid cancer indications.
In the US and Europe, irinotecan is currently mainly used for treating metastasized colorectal and pancreatic cancer. Although irinotecan is currently not approved for treating gastric cancer in the US and in the EU, there is off-label clinical use. It is also recognized in clinical guidelines (ESMO, ASCO, NCCN) in monotherapeutic or combination treatment regimens for advanced gastric cancer. In Japan, irinotecan is approved for the treatment of metastatic gastric cancer.
Oncoral is a daily irinotecan tablet with the potential to offer better patient outcomes with improved safety following the daily dosing at home compared to intravenous high-dose infusions at the hospital. Following successful Phase 1 results, Phase 2 clinical development for Oncoral is in preparation.
Please note that Oncoral is an investigational medicinal product and is not yet approved for use by regulatory authorities in any jurisdiction.