Bayer/Janssen extend clinical investigation of Xarelto

German pharma major Bayer (BAYN: DE) and its development partner Janssen Pharmaceuticals, a subsidiary of US health care giant Johnson & Johnson (NYSE: JNJ), have initiated the CALLISTO Clinical Research Program to explore the potential benefits of the oral Factor Xa inhibitor Xarelto (rivaroxaban) for the prevention and treatment of pulmonary embolism and deep vein thrombosis in patients with various types of cancer.

In patients with active cancer, the risk of venous thromboembolism (VTE) is four to seven times higher than in people of the same age without cancer. And, importantly, chemotherapy significantly increases the risk further by up to 6.5 times. Despite this, none of the current Clinical Guidelines recommend the routine use of VTE prevention in most ambulatory cancer patients. Regarding the use of anticoagulation therapy for the treatment and secondary prevention of VTE, current Clinical Guideline recommendations are based on few and small clinical trials.

Program expected to provide important clinical insights

“Today, there is limited evidence and guidance on the routine use of anticoagulants for the long-term treatment and prevention of pulmonary embolism and deep vein thrombosis in patients with cancer, despite blood clots being the leading cause of death in patients with cancer outside the cancer itself,” said Guy Meyer, a professor at the Université Paris Descartes, European Hospital Georges Pompidou, Paris, France and one of the Principal Investigators within the CALLISTO Program. “I am optimistic that results from the CALLISTO Program will provide important clinical insights to help reduce the risk of pulmonary embolism and deep vein thrombosis, conditions that can be treated and prevented,” he added.

The CALLISTO Program is a multi-trial prospective clinical research initiative aimed at generating new evidence to help manage cancer-associated thrombosis (CAT). The Program will consist of nine initiatives in total, comprising both clinical studies and Registries, and will involve more than 4,000 patients worldwide.

CALLISTO addresses three key areas of cancer-associated thrombosis: