August 19, 2015, Ballerup, Denmark - The study showed that innohep® lowered the risk of recurrent venous thromboembolism (VTE) compared to treatment with warfarin in cancer patients with symptomatic venous thromboembolism. Although the primary endpoint was not met at the 5% level, this difference may be clinically relevant in the management of patients with cancer associated thrombosis (CAT). The study also showed that treatment with innohep® significantly reduced clinically relevant non-major bleeding compared to warfarin.
Blood clots are one of the leading causes of death in patients with cancer. Approximately 1 in 10 patients with cancer dies from a blood clot related event (1,2).
“Cancer patients with VTE have a substantial risk of developing new blood clots, and optimal treatment to avoid recurrence is vital. Advancing knowledge within this area is therefore a high priority for us at LEO Pharma. We hope that the results from the CATCH study (Comparison of Acute Treatments in Cancer Haemostasis) will help to further improve the management of blood clots in cancer patients” says Kim Kjoeller, Senior Vice President from LEO Pharma.
Despite clinical practice guidelines recommending the use of low-molecular-weight heparins (LMWH) like innohep®, warfarin remains a frequently used anticoagulant treatment worldwide for cancer patients with recurrent VTE(3). The CATCH study sponsored by LEO Pharma supports the previous findings and the clinical practice guidelines.
The CATCH study is a Phase III, multinational, concealed, randomised, active-controlled, open-label trial with blinded adjudication. 900 cancer patients from Europe, Africa, Asia, North America and South America were enrolled in the study. 449 patients were treated with tinzaparin (innohep®) and 451 were treated with warfarin over a period of 180 days. During the treatment period, 7.2% of the patients treated with innohep® experienced recurrent blood clots compared to 10.5% of the patients treated with warfarin.
Dr. Agnes Lee, MD, University of British Columbia and Vancouver Coastal Health in Canada and Principal Investigator of the CATCH study commented: “This global study reinforces clinical guidelines supporting the use of low-molecular-weight heparins instead of warfarin to prevent recurrent blood clots in these patients. Our results also offer the first look at other important issues in this high-risk population, including identification of biomarkers that may predict for higher risk of recurrent blood clots, quality of life and health care economics”. About LEO Pharma
Founded in 1908, LEO Pharma is an independent, research-based pharmaceutical company. LEO Pharma develops, manufactures and markets pharmaceutical drugs to thrombotic and dermatologic patients in more than 100 countries globally. The company has its own sales force in 61 countries and employs around 4.800 people worldwide. LEO Pharma is headquartered in Denmark and is wholly owned by the LEO Foundation. For more information about LEO Pharma, please visit www.leo-pharma.com.
Notes to Editors
innohep® is a low-molecular-weight heparin (LMWH) for subcutaneous injection for the treatment of venous thrombosis and thromboembolic disease including deep vein thrombosis (DVT) and pulmonary embolism (PE). innohep® is manufactured by LEO Pharma.
About the CATCH study
CATCH is the largest randomized study conducted to date on extended treatment with LMWH to prevent recurrence of VTE in patients with active cancer3. CATCH is a Phase III, multinational, randomised, active-controlled, open-label trial with blinded adjudication assessing the efficacy and safety of long-term (6 months) innohep® (tinzaparin sodium) therapy (175 IU/kg) versus anticoagulation with warfarin for the treatment of VTE in 900 cancer patients. For further information please refer to the design paper published in BMC Cancer 2013, 13:284 by Lee et al., the primary publication in JAMA 2015;314(7):677-686 or www.clinicaltrials.gov website (identifier: NCT01130025).
About Cancer Associated Thrombosis
For the general population, the standard treatment for acute VTE consists of initial therapy with a low-molecular-weight heparin (LMWH) followed by longer-term treatment (3–6 months) with an oral vitamin K antagonist (VKA). Although this approach can be effective for many patients, cancer patients have a substantial risk of recurrent VTE. Several studies have reported incidences of recurrent VTE as high as 20% in patients with cancer (4,5). However, studies on how to treat and identify those at risk of recurrent VTE are limited (6,7) Moreover, the frequent monitoring and dose adjustments required for VKA treatment have a negative impact on Quality of Life (8).