New clinical research programme launched for the prevention and treatment of blood clots in patients with cancer

Janssen and Bayer have initiated CALLISTO, a new comprehensive clinical research programme 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.

Blood clots are the second leading cause of death in patients with cancer

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, MD, Chief, Haematology Service, Memorial Sloan Kettering Cancer Centre, New York, NY, 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.”

CALLISTO will evaluate the field of cancer-associated blood clots

Known as CALLISTO, the new oncology research programme is part of Janssen and Bayer HealthCare’s broader EXPLORER clinical development programme, evaluating patient populations being treated for blood clots or at high risk for developing them. The CALLISTO programme will encompass the field of cancer-associated blood clots through nine studies, including seven clinical trials and two registries across various cancer types, in more than 4,000 patients globally.

The advisory council for the programme will be chaired by Alok A. Khorana, MD, FACP, Sondra and Stephen Hardis Chair in Oncology, Vice Chair for Clinical Services, Director of the GI Malignancies Programme, Taussig Cancer Institute Cleveland Clinic, Cleveland, OH.

“Cancer-associated thrombosis is a highly prevalent complication of cancer treatments, including chemotherapy, targeted therapy and small molecules. Occurrence of clots can disrupt patient quality of life, affect delivery of cancer treatments and increase the number of hospitalizations and use of healthcare resources,” said Dr Khorana. “Although it may be largely preventable, focused studies in the cancer population using newer, more patient-friendly agents have not yet been conducted. This planned programme that will engage cancer researchers nationwide seeks to address this unmet need of cancer patients, and the prevention and treatment of cancer-associated thrombosis.”

The research will evaluate rivaroxaban in the prevention and treatment of VTE, and in relevant clinical aspects.

“CALLISTO is unlike any other initiative for cancer-associated blood clots in its scope, size and ambition,” said Paul Burton, MD, PhD, Vice President, Medical Affairs, Janssen. “The programme 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.”