SHR-2004, a Humanized Monoclonal Antibody Targeting Factor XI, for Preventing Venous Thromboembolism After Ovarian Cancer Surgery: A Randomized, Active-Controlled Phase 2 Study.
Guangyi Jiang, Jie Tang, Hongwei Zhao et al.
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In 30 seconds
This multicenter, open-label, randomized Phase 2 trial compared the factor XI-targeting antibody SHR-2004 with enoxaparin followed by rivaroxaban for postoperative venous thromboembolism (VTE) prevention in patients undergoing surgery for newly diagnosed advanced or recurrent ovarian cancer. Among 181 patients completing protocol-mandated ultrasonography, VTE by Day 28 occurred in 11 (12.6%) with SHR-2004 and 19 (20.2%) with enoxaparin-rivaroxaban (difference -8.4%, 95% CI -19.9 to 3.1). Major or clinically relevant nonmajor bleeding rates were similar. The exploratory findings suggest comparable efficacy and safety, but require confirmation in adequately powered Phase 3 trials.
Key findings
- By Day 28, VTE occurred in 11 (12.6%) patients receiving SHR-2004 and 19 (20.2%) receiving enoxaparin-rivaroxaban (difference -8.4%, 95% CI -19.9 to 3.1).
- Major or clinically relevant nonmajor bleeding occurred in 2/90 (2.2%) with SHR-2004 and 2/108 (1.9%) with enoxaparin-rivaroxaban.
Why it matters
Patients undergoing ovarian cancer surgery face substantial thrombotic risk, making effective postoperative prevention important. This trial provides early comparative evidence for a factor XI-targeting antibody with a twice-monthly dosing schedule, alongside bleeding outcomes, in this population. The results are relevant to further evaluation of alternative prevention strategies, but the exploratory Phase 2 findings do not establish superiority or equivalence.
What to keep in mind
The study was exploratory and Phase 2; only 181 patients completed protocol-mandated ultrasonography, and the reported confidence interval for the VTE difference includes no difference.