Janssen’s Xarelto studied for secondary prevention of VTE in cancer patients
The Janssen Pharmaceutical Companies of Johnson & Johnson recently announced observational data from 8 years of clinical practice showing that the company’s oral Factor Xa inhibitor Xarelto (rivaroxaban) is associated with comparable effectiveness and safety to the Factor Xa inhibitor apixaban for the treatment of cancer-associated thromboembolism (CAT) in a broad cohort of patients with various cancer types. Patients with CAT are at a higher risk of venous thromboembolism (VTE), which is the second-leading cause of death in people with cancer, noted the company.
According to Janssen, data from OSCAR found that Xarelto showed noninferiority for the composite outcome of recurrent VTE or any bleeding resulting in hospitalization for treatment of patients with CAT.
Janssen and its development partner Bayer featured results from OSCAR in an oral presentation at the American Society of Hematology’s 64th annual meeting and exposition held December 10-13 in New Orleans, Louisiana. The company advised that the study adds to the real-world evidence for Xarelto, including > 300,000 patients who were treated with Xarelto and evaluated in published real-world research since its initial approval in the United States in 2011.
Janssen stated that previous studies such as SELECT-D and CONKO-11 demonstrated that changing from a low-molecular-weight heparin (LMWH) to Xarelto was associated with a reduction in risk of recurrent thrombosis and improved patient satisfaction.
As summarized in the company’s press release, this observational study used Optum’s deidentified electronic health data from January 2013 to December 2020.
The study included a cohort of 2,437 patients (aged ≥ 18 years) with CAT for whom direct oral anticoagulants are endorsed by guidelines as alternatives to LMWH. Patients with active cancer, excluding esophageal, gastric, unresected colorectal, bladder, leukemia, or central nervous system cancers (except brain cancer, which was included), were enrolled in the study after experiencing a hospital, emergency department, or observation unit admission for VTE or pulmonary embolism event.
The retrospective 8-year study assessed the time to first composite event of recurrent VTE or any bleeding resulting in hospitalization at a minimum follow-up of 3 months. Other outcomes assessed included the composite of recurrent VTE or any critical organ bleeding, recurrent VTE, any bleeding resulting in hospitalization, and any critical organ bleeding at 3 and 6 months.
The investigators found that at 3 and 6 months, Xarelto was as effective and safe as apixaban in the composite outcome of recurrent VTE or bleeding-related hospitalization. At 3 months, patients receiving Xarelto had a numerically lower rate of the primary endpoint (5.3% vs 6.0%; hazard ratio, 0.87; 95% CI, 0.60-1.27). No significant differences were observed between groups for this outcome at 6 months or for other outcomes at 3 or 6 months.
“The OSCAR study provides robust, real-world evidence in patients with CAT and builds upon previous Xarelto safety and efficacy data observed in both clinical practice and in randomized clinical trials,” commented Craig I. Coleman, PharmD, in the company’s press release. “The data show Xarelto can be an effective option for these patients who are at an increased risk of potentially life-threatening blood clots.” Dr. Coleman is from the School of Pharmacy at the University of Connecticut in Storrs, Conn.