Wolfgang Miesbach Shares Insights from Davide Matino’s Presentation on Marstacimab at ASH25
Wolfgang Miesbach, Professor of Medicine at Frankfurt University Hospital, shared on LinkedIn:
”ASH25: Introducing fixed-dose marstacimab as prophylaxis for patients with haemophilia A and B with inhibitors (>12 years and < 75 years).
Phase 3 BASIS trial results presented by Davide Matino at ASH2025 demonstrate safety and efficay data.
Marstacimab, a monoclonal IgG1 antibody targeting tissue factor pathway inhibitor (TFPI), increased thrombin generation and clot formation. In the BASIS trial, weekly subcutaneous (SC) marstacimab at 150 mg (after 300 mg loading dose) proved superior to on-demand treatment:
- Primary endpoint exceeded: Marstacimab reduced annualized bleeding rate (ABR) for treated bleeds to 1.4 vs. 19.8 for on-demand (p<0.0001) — a 93% reduction
- Consistent efficacy across populations: ABR reductions held steady across hemophilia type (A and B), age groups (adolescents and adults), and geographic regions
- Meaningful clinical impact: 57.8% of marstacimab-treated patients achieved zero treated bleeds during follow-up
- Superior secondary endpoints: Significant reductions in joint bleeds, spontaneous bleeds, and target joint bleeding—all critical for long-term musculoskeletal health
Treatment Advantages:
- Fixed weekly SC dosing—no more reactive bypassing agent consumption
- Dramatic reduction in bypassing agent use: ~94% reduction in yearly aPCC and rFVIIa consumption
- Improved quality of life markers: Significant improvements in Haem-A-QoL physical health domain (−25.9 points, p<0.0001) and total score (−13.5 points, p<0.001
Safety Profile:
✔ Well-tolerated across both observational and active treatment phases
✔ No thromboembolic events detected in patients with inhibitors—a critical reassurance for TFPI targeting strategies
✔ Most adverse events mild to moderate; injection site reactions manageable
✔ ADA formation in 10/51 patients (19.6%) had no clinical impact—titers low with natural resolution”
All from ASH25 featured in Hemostasis Today.
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