Study is evaluating efficacy, immunogenicity, and product safety for eculizumab in patients with paroxysmal nocturnal hemoglobinuria.
Amgen announced positive topline results from the DAHLIA study (NCT03818607), which evaluated the efficacy, immunogenicity, and safety of ABP 959, a biosimilar to eculizumab (Soliris; Alexion, AstraZeneca) compared to eculizumab in adults with paroxysmal nocturnal hemoglobinuria (PNH) ).1
“We look forward to working with regulators to make this potential biosimilar option available to patients,” said David Reese, MD, executive vice president of Research and Development at Amgen, in a statement.1
The active-controlled, double-blind, randomized 2-period Phase 3 study met the primary endpoint and showed no clinically relevant differences between ABP 959 and eculizumab.1
This was based on the control of intravascular hemolysis as measured by lactate dehydrogenase (LDH) at week 27 for parallel comparison and the time-corrected area under the effect curve of LDH from week 13 to week 27, from week 39 to week 53, and from week 65 to week 79 for the crossover comparison.1
Researchers also noted that the immunogenicity and safety profile of both drugs were similar.1
The study included subjects with PNH who had previously been treated with eculizumab for at least 6 months. Researchers randomized individuals 1 to 1 to receive each study product in 1 of 2 sequences: either treatment T followed by treatment R or treatment R followed by treatment T.1
The treatment was administered over 2 periods: period 1 was 52 weeks long and period 2 started at week 53 with a treatment crossover and lasted 26 weeks.1
Treatment T consisted of treatment with ABP 959 at a dose of 900 mg intravenously approximately every 14 days, while treatment R consisted of eculizumab at a dose of 900 mg administered intravenously approximately every 14 days.1
Detailed results of the study will be presented at a future medical conference and will be submitted for publication.1
ABP 959 is being developed as a biosimilar candidate for eculizumab not only for the treatment of PNH, but also for other indications. It has the same dosage strength, dosage schedule, pharmaceutical form and route of administration as eculizumab which is authorized in the European Union and the United States.1
ABP 959 is not commercially available.1
Amgen has a total of 11 biosimilars in its portfolio, including 5 approved in the United States, 3 approved in the European Union and 3 in Phase 3 development.1
PNH is a condition that can lead to premature death and decrease blood cell production, according to the National Center for Advancing Translational Sciences.2
The condition is usually diagnosed in young adulthood and has symptoms such as abnormally pale skin, fatigue, increased heart rate, shortness of breath, and weakness.2
Reference
1. Study evaluated the efficacy, safety, and immunogenicity of ABP 959 compared to eculizumab in patients with paroxysmal nocturnal hemoglobinuria. news item. amgen. Aug 23, 2022. Accessed Aug 24, 2022. https://wwwext.amgen.com/newsroom/press-releases/2022/08/amgen-announces-positive-topline-results-from-phase-3-study-of – abp-959-biosimilar-candidate-to-soliris-eculizumab
2. Paroxysmal nocturnal hemoglobinuria. National Center for Advancing Translational Sciences. Updated November 8, 2021. Accessed August 24, 2022. https://rarediseases.info.nih.gov/diseases/7337/paroxysmal-nocturnal-hemoglobinuria