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The PEGASUS study

The PEGASUS study

A Phase 3, head-to-head study of Aspaveli vs eculizumab1

The PEGASUS study (N=80) was a Phase 3, randomised 1:1, open-label, head-to-head, 16-week study of Aspaveli vs eculizumab in eculizumab-treated patients with PNH who remained anaemic.*1

*In patients with Hb levels <10.5 g/dL despite treatment with eculizumab for ≥3 months.1

Pegasus study design

A total of 38 patients in the Aspaveli group and 39 patients in the eculizumab group completed the 16-week randomised control period. They then entered a 32-week open-label period and received monotherapy with Aspaveli.1

Primary endpoint:1

  • Change in Hb levels from baseline to Week 16 vs eculizumab

Key secondary endpoints:1,2

  • Freedom from transfusions, change in ARC, LDH, and FACIT-Fatigue score from baseline to Week 16 vs eculizumab

ARC=absolute reticulocyte count; FACIT=Functional Assessment of Chronic Illness Therapy; Hb=haemoglobin; LDH=lactate dehydrogenase; PNH=paroxysmal nocturnal haemoglobinuria.

References: 1. Hillmen P, Szer J, Weitz I, et al. Pegcetacoplan versus eculizumab in paroxysmal nocturnal hemoglobinuria. N Engl J Med. 2021;384:1028–1037. 2. Hillmen P, Szer J, Weitz I, et al. Pegcetacoplan versus eculizumab in paroxysmal nocturnal hemoglobinuria. N Engl J Med. 2021;384(suppl):1–16.