Post-hoc analysis of phase III study for Epysqli (SB 12; eculizumab biosimilar), at the European Hematology Association (EHA) Congress 2024

The post-hoc analysis of SB 12 pivotal Phase III study compared the proportion of patients remaining transfusion-free (“transfusion avoidance”) among those treated with SB 12 or reference eculizumab (ECU), respectively. Eculizumab is known to significantly reduce hemolysis resulting in improvements in anemia as indicated by increased hemoglobin stabilization and reduced need for red blood cell (RBC) transfusions.

For this study, 50 adults with PNH who were complement-inhibitor naïve were randomized (1:1) to treatment sequence I (TS1: SB 12 to ECU, n=25) or II (TS2: ECU to SB 12, n=25), to receive 600 mg of SB 12 or ECU intravenously every week for first 4 weeks and 900 mg for the fifth week, followed by 900 mg every 2 weeks thereafter. At Week 26, patients were switched to ECU or SB 12, respectively, and received infusion until Week 50. (i.e., Period 1 followed by Period 2 from Week 26). This efficacy analysis was conducted in pooled patients treated with SB 12 or ECU in either Periods 1 or 2.

Transfusion avoidance was 68.1% for patients who received SB 12 versus 72.9% for patients who received reference eculizumab, with a difference of -5.3% [95% confidence interval (CI), (-18.9%, 8.4%), p-value 0.4492], resulting in non-significant difference between the two treatment groups.

This post-hoc analysis supports the previously demonstrated comparable clinical efficacy of SB 12 with reference eculizumab in treating PNH patients, with no significant difference in reducing transfusion burden compared to reference eculizumab,” said Hyejin Kim, Vice President and Medical & Lifecycle Safety Team Leader at Samsung Bioepis. “Our dedication to make a meaningful difference to our patients remain steadfast. We will continue to work collaboratively with clinicians and physicians to further expand the treatment options for patients with orphan diseases.”