Janssen, Bayer initiate anticoagulant rivaroxaban trials
Janssen Pharmaceuticals and its development partner, Bayer HealthCare, have initiated CALLISTO, a new comprehensive clinical research program for their novel oral anticoagulant, rivaroxaban, in patients with active cancer. The studies are evaluating the medicine for the prevention and treatment of life-threatening blood clots in patients with a wide range of cancer types.
In patients with cancer, the risk of venous thromboembolism (VTE), which is a blood clot in the deep veins or the lungs, is up to five times higher compared to people the same age without cancer, and the risk magnifies in those receiving chemotherapy. The occurrence of VTE may also cause delays in patients receiving critical treatment for their cancer, including surgery or chemotherapy. Blood clots are the second leading cause of death in patients with cancer and preventing their occurrence represents a significant unmet need for patients and their providers.
"Not only are blood clots more severe and widespread in the body of patients with cancer, but their development is also linked to the management of cancer," said Gerald A. Soff, M.D., chief, hematology service, Memorial Sloan Kettering Cancer Center, New York, and a Principal Investigator in CALLISTO. "Though blood clots are largely preventable, current therapy is only approved for the treatment of these clots after they've formed, or to prevent clots in patients who are hospitalized. This means a large number of the one million patients who are treating their cancer outside the hospital each year are at risk of developing blood clots, and reducing their incidence is a high priority in cancer care."
Known as CALLISTO, the new oncology research program is part of Janssen and Bayer HealthCare's broader EXPLORER clinical development program, evaluating patient populations being treated for blood clots or at high risk for developing them. The CALLISTO program will encompass the field of cancer-associated thrombosis (blood clots) through nine studies, including seven clinical trials and two registries across various cancer types, in more than 4,000 patients globally.
"CALLISTO is unlike any other initiative for cancer-associated blood clots in its scope, size and ambition," said Paul Burton, M.D., Ph.D., vice president, medical affairs, Janssen. "The program will harness our deep experience in oncology and thrombosis so that we can better assess how to reduce the burden of blood clots in patients with cancer, while also improving our understanding of how rivaroxaban may be used in the context of complex cancer treatment strategies. Through CALLISTO, part of our broader EXPLORER program, which includes six additional indication-seeking studies underway in collaboration with Bayer HealthCare, we are striving to uncover the full potential of our medicine in making a difference for patients with critical medical needs.”
The EXPLORER program is evaluating patients with chronic heart failure, coronary artery disease, peripheral artery disease, acute coronary syndrome, embolic stroke of undetermined source and now, active cancer. By the time of its completion, more than 275,000 patients will have participated in the clinical development program, other completed and ongoing clinical trials, investigative registries, and non-interventional studies.