Apellis to Present New Data Supporting the Efficacy and Safety of Pegcetacoplan in PNH at the American Society of Hematology Annual Meeting

Nachrichtenquelle: globenewswire
05.11.2020, 13:00  |  113   |   |   

  • Eight abstracts accepted for presentation emphasize the potential of targeted C3 therapy to elevate the standard of care in paroxysmal nocturnal hemoglobinuria (PNH)
  • New analyses from the Phase 3 PEGASUS head-to-head study demonstrate greater treatment response and quality-of-life improvements with pegcetacoplan versus eculizumab, a C5 inhibitor

  • Using a matching-adjusted indirect comparison (MAIC), improvements in clinical, hematological and quality-of-life outcomes were demonstrated in patients treated with pegcetacoplan compared to ravulizumab, a long-acting C5 inhibitor

WALTHAM, Mass., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced that eight abstracts were accepted for presentation at the virtual American Society of Hematology (ASH) Annual Meeting to be held December 5-8, 2020. Data support the positive efficacy and safety of pegcetacoplan, a targeted C3 therapy, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).

Highlights include new analyses from the Phase 3 head-to-head PEGASUS study, which demonstrate a markedly greater proportion of patients achieved better hematological responses as well as quality-of-life improvements with pegcetacoplan versus eculizumab, a C5 inhibitor. Additionally, using a matching-adjusted indirect comparison (MAIC) methodology, patients treated with pegcetacoplan enrolled in the PEGASUS study experienced greater improvements in hemoglobin stabilization, transfusion avoidance and fatigue compared to patients treated with ravulizumab, a long-acting C5 inhibitor, using the data from the ALXN1210-PNH-302 published study. In the absence of a clinical head-to-head study, MAIC is a valid and accepted method for comparative effectiveness research used by health technology assessment bodies across the world.1,2

“We continue to see in the analyses that pegcetacoplan demonstrated a substantial improvement over C5 inhibition,” said Federico Grossi, M.D., Ph.D., Chief Medical Officer of Apellis. “The breadth of data that we are presenting at ASH this year emphasizes the potential of pegcetacoplan to elevate the standard of care in PNH.”

Accepted abstracts regarding pegcetacoplan include:

  • Results of the PEGASUS Phase 3 Randomized Trial Demonstrating Superiority of the C3 Inhibitor, Pegcetacoplan, Compared to Eculizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria – #2579 – December 7, 7:00 a.m. – 3:00 p.m. PT
  • Categorized Hematologic Response to Pegcetacoplan Versus Eculizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria: Post Hoc Analysis of Data from a Phase 3 Randomized Trial (PEGASUS) – #2588 – December 7, 7:00 a.m. – 3:00 p.m. PT
  • Effect of Pegcetacoplan on Quality of Life in Patients with Paroxysmal Nocturnal Hemoglobinuria from the PEGASUS Phase 3 Trial Comparing Pegcetacoplan to Eculizumab – #764 – December 5, 7:00 a.m. – 3:30 p.m. PT
  • Pegcetacoplan is Superior to Eculizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria Regardless of Prior Transfusion Requirement – #1681 – December 6, 7:00 a.m. – 3:30 p.m. PT
  • C3 Inhibition with Pegcetacoplan in Patients with Paroxysmal Nocturnal Hemoglobinuria: Results from the PADDOCK and PALOMINO Trials – #753 – December 5, 7:00 a.m. – 3:30 p.m. PT
  • Comparative Effectiveness of Pegcetacoplan Versus Ravulizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria Previously Treated with Eculizumab: A Matching-Adjusted Indirect Comparison – #2581 – December 7, 7:00 a.m. – 3:00 p.m. PT

Accepted abstracts regarding additional data in the PNH population include:

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Apellis to Present New Data Supporting the Efficacy and Safety of Pegcetacoplan in PNH at the American Society of Hematology Annual Meeting Eight abstracts accepted for presentation emphasize the potential of targeted C3 therapy to elevate the standard of care in paroxysmal nocturnal hemoglobinuria (PNH) New analyses from the Phase 3 PEGASUS head-to-head study demonstrate greater …

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