Post-hoc analysis of Phase 3 study to highlight transfusion avoidance results of SB12 compared to reference eculizumab-treated groups INCHEON, Korea, May 30, 2024 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. today announced that a post-hoc analysis of the Phase 3 clinical study results for EPYSQLI™ (SB12), a biosimilar to Soliris1 (eculizumab), will be presented at the 29th European Hematology Association 2024 (EHA2024) Hybrid Congress held in Madrid, Spain and virtually, from June 13 to 16, 2024. The post-hoc analysis of SB12 pivotal Phase 3 study presented at EHA2024 compared the proportion of patients remaining transfusion-free (“transfusion avoidance”) among those treated with SB12 or 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.3 “We are excited to present this data at EHA2024, that adds to the growing body of evidence that supports comparable clinical efficacy of SB12 with reference eculizumab in treating PNH patients,” said Hyejin Kim, Vice President and Medical & Lifecycle Safety Team Leader at Samsung Bioepis. “We will continue to advance with our scientific research, publication and educational activities to bring more awareness of biosimilars for rare disease treatment and hope our study results serve as a guidance for clinicians.” Details of the SB12 abstract are as follows:
Abstract title: Transfusion Avoidance with EPYSQLI™(SB12), A Biosimilar to Reference Eculizumab: A Post-hoc Analysis from the Pivotal Phase 3 Study Program type: e-Poster Presentation
Authors: Jun Ho Jang, Jihye Park, Younsoo Kim, Jihyun Han and Paola Russo
EPYSQLI EU Important Safety Information The EU Summary of Product Characteristics for EPYSQLI includes the following Special warning and Precautions: EPYSQLI increases patient's susceptibility to Meningococcal infection (Neisseria meningitidis). Meningococcal disease due to any serogroup may occur. To reduce the risk of infection, all patients must be vaccinated at least 2 weeks prior to receiving eculizumab unless the risk of delaying eculizumab therapy outweighs the risks of developing a meningococcal infection. Patients who initiate eculizumab treatment less than 2 weeks after receiving a tetravalent meningococcal vaccine must receive treatment with appropriate prophylactic antibiotics until 2 weeks after vaccination. Vaccines against serogroups A, C, Y and W 135 are recommended in preventing the commonly pathogenic meningococcal serogroups. Vaccines against serogroup B where available are also recommended. Patients must receive vaccination according to current national vaccination guidelines for vaccination use. Vaccination may further activate complement. As a result, patients with complement-mediated diseases, including PNH and aHUS, may experience increased signs and symptoms of their underlying disease, such as haemolysis (PNH) or TMA (aHUS). Therefore, patients should be closely monitored for disease symptoms after recommended vaccination. Vaccination may not be sufficient to prevent meningococcal infection. Consideration should be given to official local guidance on the appropriate use of antibacterial agents. Cases of serious or fatal meningococcal infections have been reported in eculizumab-treated patients. All patients should be monitored for early signs of meningococcal infection, evaluated immediately if infection is suspected, and treated with appropriate antibiotics if necessary. Patients should be informed of warning signs and symptoms and steps taken to seek medical care immediately. Patients may have increased susceptibility to other type of serious infections, especially with Neisseria and encapsulated bacteria. Treatment with EPYSQLI should not alter anticoagulant management. PNH Laboratory Monitoring
PNH patients should be monitored for signs and symptoms of intravascular haemolysis, including serum lactate dehydrogenase (LDH) levels, and may require dose adjustment within the recommended 14±2 day dosing schedule during the maintenance phase (up to every 12 days). aHUS Laboratory Monitoring
aHUS patients receiving eculizumab therapy should be monitored for thrombotic microangiopathy by measuring platelet counts, serum LDH and serum creatinine, and may require dose adjustment within the recommended 14±2 day dosing schedule during the maintenance phase (up to every 12 days). Treatment Discontinuation for PNH
Treatment Discontinuation for aHUS
Refer to the Summary of Product Characteristics (SmPC) for EPYSQLI’s full safety information. Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, endocrinology, hematology and nephrology. For more information, please visit: www.samsungbioepis.com and follow us on social media – follow us on social media – X, LinkedIn. 2 Jang JH, Gomez RD, Bumbea H, Nogaieva L, Wong LLL, Lim SM, Kim Y, Park J. A phase III, randomised, double-blind, multi-national clinical trial comparing SB12 (proposed eculizumab biosimilar) and reference eculizumab in patients with paroxysmal nocturnal haemoglobinuria. EJHaem. 2022 Dec 20;4(1):26-36. doi: 10.1002/jha2.632. PMID: 36819188; PMCID: PMC9928655. 3 European Medicines Agency. Soliris Product Information. https://www.ema.europa.eu/en/documents/product-information/soliris-epar-product-information_en.pdf. Accessed May 2024
4 European Medicines Agency. Epysqli Product Information. https://www.ema.europa.eu/en/documents/product-information/epysqli-epar-product-information_en.pdf. Accessed May 2024