Samsung Bioepis touts Phase III results for Epysqli at EHA

South Korea’s Samsung Bioepis today presented the post-hoc analysis of the Phase III clinical study results for Epysqli (SB12), a biosimilar to AstraZeneca’s (LSE: AZN) Soliris (eculizumab), at the 29th European Hematology Association 2024 Hybrid Congress being held in Madrid, Spain.

The post-hoc analysis of SB12 pivotal Phase III study compared the proportion of patients remaining transfusion-free (transfusion avoidance) among those treated with SB12 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: SB12 to ECU, n=25) or II (TS2: ECU to SB12, n=25), to receive 600 mg of SB12 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 SB12, 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 SB12 or ECU in either Periods 1 or 2.