AstraZeneca demonstrates pipeline and portfolio strength across malignant and rare haematological diseases at EHA 2022

| 9 juni, 2022 | 0 kommentarer

Calquence in combination with obinutuzumab shows longer-term overall survival at five years in 1st-line chronic lymphocytic leukaemia.
Survival data will support long-term use of Ultomiris for the treatment of paroxysmal nocturnal haemoglobinuria.

AstraZeneca will showcase data demonstrating the Company’s commitment to redefine care in haematology at the European Hematology Association (EHA) Annual Meeting, 9 to 12 June 2022.

A total of five approved and potential new medicines from AstraZeneca will be featured across 16 abstracts, including one oral presentation. These include long-term follow-up data for Calquence (acalabrutinib) in adults with previously untreated and relapsed or refractory chronic lymphocytic leukaemia (CLL).1,2 Additionally, Alexion, AstraZeneca’s Rare Disease group, will present an analysis of long-term survival data from the clinical trial programme evaluating Ultomiris (ravulizumab) for the treatment of paroxysmal nocturnal haemoglobinuria (PNH).3 One-year safety and efficacy data from the Phase III clinical trial evaluating the subcutaneous administration of Ultomiris will also be presented.4

Anas Younes, Senior Vice President, Haematology R&D, AstraZeneca, said: “At this year’s European Hematology Association Annual Meeting, we are demonstrating our strength across a broad spectrum of haematological malignancies, and specifically in chronic lymphocytic leukaemia,  to help improve outcomes for these patients. The data from our portfolio and pipeline represent the outcome of years of dedication and passion focused on delivering improved treatment options that can have a long-term impact for patients with chronic, hard-to-treat and rare blood conditions.”

Christophe Hotermans, MD, PhD, Senior Vice President, Global Medical Affairs, Alexion, said: “The collective clinical and real-world data being presented at the European Hematology Association Annual Meeting will strengthen the body of scientific evidence supporting the effective and well-tolerated use of targeted C5 complement inhibition, which is the standard of care in paroxysmal nocturnal haemoglobinuria. The data reinforce targeting of the terminal complement system through C5 inhibition to reduce intravascular haemolysis and thrombosis in this devastating disease.”

Redefining expectations for patients with CLL

  • Updated data from the ELEVATE-TN Phase III trial at approximately five years of median follow-up will highlight longer-term safety, progression-free survival (PFS) efficacy results and overall survival rates for Calquence in combination with obinutuzumab and alone compared to obinutuzumab plus chlorambucil in adults with previously untreated CLL.1
  • Updated data from the ASCEND Phase III trial at approximately four years of median follow-up will highlight longer-term safety and PFS efficacy results of Calquence alone compared to investigator’s choice of idelalisib plus rituximab or bendamustine plus rituximab in adults with relapsed or refractory CLL.2
  • A pooled analysis of data among previously untreated and relapsed or refractory CLL patients with higher-risk genomic features taking Calquence will explore the efficacy  of Calquence-based regimens for these sub-groups of patients, regardless of line of therapy.5
  • A crossover analysis from the ELEVATE-TN trial will test the hypothesis that treatment crossover upon disease progression from the obinutuzumab plus chlorambucil arm to the Calquence arm bolstered overall survival for the obinutuzumab plus chlorambucil arm at 47 months of follow-up.6

Improving understanding of hard-to-treat blood cancers

  • A post-hoc analysis of the ACE-LY-004 Phase II trial will highlight the clinical benefit seen with patients taking Calquence who had one prior therapy and with highly proliferative variants of relapsed or refractory mantle cell lymphoma (MCL).7
  • Final results at five-year median follow-up from the WM-001 Phase II trial will highlight response rates and tolerability seen with Calquence in patients with previously untreated or relapsed or refractory Waldenström macroglobulinemia (WM).8
  • Early results from a Phase II trial will show the efficacy and tolerability of Calquence in patients with relapsed or refractory marginal zone lymphoma (MZL).9

Advancing treatment and care for patients with PNH

  • Pooled, long-term, survival data for more than four years from the Ultomiris PNH clinical trial programme will highlight long-term use of Ultomiris in the treatment of adults with PNH.3 Ultomiris has the largest clinical trial programme in PNH, with the longest follow-up, and demonstrates the benefits of immediate, complete and sustained terminal complement inhibition in this rare disease.
  • Data through one year on the efficacy, safety and treatment administration satisfaction will be presented from the Phase III clinical trial evaluating the subcutaneous administration of Ultomiris with an on-body delivery system in adults with PNH who had received prior intravenous treatment with Soliris (eculizumab).4

Key AstraZeneca presentations during EHA 2022

Lead author Abstract title Presentation details
Calquence (acalabrutinib)
Sharman, JP Acalabrutinib ± Obinutuzumab vs Obinutuzumab + Chlorambucil in Treatment-Naive Chronic Lymphocytic Leukemia: 5-Year Follow-up of ELEVATE-TN Abstract # P666 Poster PresentationPoster Session10 June 202216:30 – 17:45 CEST
Ghia, P Acalabrutinib vs Rituximab Plus Idelalisib or Bendamustine in Relapsed/Refractory Chronic Lymphocytic Leukemia: ASCEND Results at ~4 Years of Follow-up Abstract # P668Poster PresentationPoster Session10 June 202216:30 – 17:45 CEST
Davids, MS Long-term Efficacy of Acalabrutinib-Based Regimens in Patients With Chronic Lymphocytic Leukemia and Higher-risk Genomic Features: Pooled Analysis of Clinical Trial Data Abstract # P667Poster PresentationPoster Session10 June 2022 16:30 – 17:45 CEST
Gaitonde, P Adjusting Survival Data for Treatment Crossover in the ELEVATE-TN Trial by Using a Historical Cohort of Patients Treated with Chemoimmunotherapy in Front-Line Chronic Lymphocytic Leukemia  Abstract # PB1877 e-Publication Online Only 12 May 2022
Le Gouill, S Post Hoc Analysis of Patients With Highly Proliferative Variants of Mantle Cell Lymphoma Treated With Acalabrutinib Abstract # P1131Poster PresentationPoster Session10 June 202216:30 – 17:45 CEST
Owen, R Acalabrutinib in Treatment-Naive or Relapsed/Refractory Waldenström Macroglobulinemia: 5-Year Follow-up of a Phase 2, Single-Arm Study Abstract # P1130Poster PresentationPoster Session10 June 202216:30 – 17:45 CEST
Strati, P Acalabrutinib in Patients With Relapsed/Refractory (R/R) Marginal Zone Lymphoma (MZL): Results of a Phase 2, Multicenter, Open-label Trial Abstract # P1129Poster PresentationPoster Session10 June 202216:30 – 17:45 CEST
Ultomiris (ravulizumab)
Kulasekararaj, A Long-Term Complement Inhibition and Survival Outcomes in Patients with Paroxysmal Nocturnal Hemoglobinuria: An Interim Analysis of the Ravulizumab Clinical Trials Abstract # P812Poster PresentationPoster Session10 June 202216:30 – 17:45 CEST
Yenerel, M Efficacy, Treatment Administration Satisfaction and Safety of Subcutaneous Ravulizumab Through 1 Year in Patients with Paroxysmal Nocturnal Hemoglobinuria Who Received Prior Intravenous Eculizumab Abstract # P813Poster PresentationPoster Session10 June 202216:30 – 17:45 CEST
Soliris (eculizumab) 
Nishimura, J Real-World Outcomes of Eculizumab Treatment in Patients with Paroxysmal Nocturnal Hemoglobinurea: A Systematic Literature Review and Evidence Synthesis Abstract # PB1934e-PublicationOnline Only12 May 2022
Rovó, A Real-World Evidence of Safety and Effectiveness of Eculizumab and Switch to Ravulizumab in a Swiss Patient Population With Paroxysmal Nocturnal Hemoglobinuria Abstract # P834Poster PresentationPoster Session10 June 202216:30 – 17:45 CEST
ALXN1820
Kim, S Properdin-Blocking Antibodies Attenuate Complement Alternative Pathway Activation Triggered by Cell-Free Heme in Sickle Cell Disease Models Abstract # S267Oral PresentationSession – Sickle Cell Disease: Novel Biomarkers and Therapies12 June 202211:30 – 12:45 CEST

Notes

AstraZeneca in haematology
AstraZeneca is pushing the boundaries of science to redefine care in haematology. We have expanded our commitment to patients with haematologic conditions, not only in oncology but also in rare diseases with the acquisition of Alexion, allowing us to reach more patients with high unmet needs. By applying our deep understanding of blood cancers, leveraging our strength in solid tumour oncology and delivering on Alexion’s pioneering legacy in complement science to provide innovative medicines for rare diseases, we are pursuing the end-to-end development of novel therapies designed to target underlying drivers of disease.

By targeting haematological conditions with high unmet medical needs, we aim to deliver innovative medicines and approaches to improve patient outcomes. Our goal is to help transform the lives of patients living with malignant, rare and other related haematologic diseases, shaped by insights from patients, caregivers and physicians to have the most meaningful impact.  

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

Alexion
Alexion, AstraZeneca Rare Disease, is the group within AstraZeneca focused on rare diseases, created following the 2021 acquisition of Alexion Pharmaceuticals, Inc. As a leader in rare diseases for nearly 30 years, Alexion is focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialisation of life-changing medicines. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on haematology, nephrology, neurology, metabolic disorders, cardiology and ophthalmology. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries.

AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.

Contacts
For details on how to contact the Investor Relations Team, please click here. For media contacts, click here.

References

  1. Sharman JP, Egyed M, Jurczak W, et al. Acalabrutinib ± Obinutuzumab vs Obinutuzumab +  Chlorambucil in Treatment-Naive Chronic Lymphocytic Leukemia: 5-Year Follow-Up of ELEVATE-TN [abstract and poster]. Presented at: European Hematology Association (EHA) Congress; June 9-17; Vienna, Austria. Abs P666
  2. Ghia P, Pluta A, Wach M, et al. Acalabrutinib vs Rituximab Plus Idelalisib or Bendamustine in Relapsed/Refractory Chronic Lymphocytic Leukemia: ASCEND Results at ~4 Years of Follow-up [abstract and poster]. Presented at: EHA Congress; June 9-17; Vienna, Austria. Abs P668
  3. Kulasekararaj, A, Brodsky R, Griffin M, et al. Long-term Complement Inhibition and Survival Outcomes in Patients with Paroxysmal Nocturnal Hemoglobinuria: An Interim Analysis of the Ravulizumab Clinical Trials [abstract and poster]. Presented at: EHA Congress; June 9-17; Vienna, Austria. Abs P812
  4. Yenerel, M, Sicre de Fontbrune F, Piatek C, et al. Efficacy, Treatment Administration Satisfaction and Safety of Subcutaneous Ravulizumab Through 1 Year in Patients With Paroxysmal Nocturnal Hemoglobinuria Who Received Prior Intravenous Eculizumab [abstract and poster]. Presented at: EHA Congress; June 9-17; Vienna, Austria. Abs P813
  5. Davids MS, Sharman JP, Ghia P, et al. Long-term Efficacy of Acalabrutinib-based Regimens in Patients With Chronic Lymphocytic Leukemia and Higher-risk Genomic Features: Pooled Analysis of Clinical Trial Data [abstract and poster]. Presented at: EHA Congress; June 9-17; Vienna, Austria. Abs P667
  6. Gaitonde P, Liljas B, Shaw B, et al. Adjusting Survival Data for Treatment Crossover in the ELEVATE-TN Trial by Using a Historical Cohort of Patients Treated With Chemoimmunotherapy in Front-Line Chronic Lymphocytic Leukemia [e-publication]. Presented at: EHA Congress; June 9-17; Vienna, Austria. Abs PB1877
  7. Le Gouill S, Długosz-Danecka M, Rule S, et al. Post Hoc Analysis of Patients With Highly Proliferative Variants of Mantle Cell Lymphoma Treated With Acalabrutinib [abstract and poster] Presented at: EHA Congress; June 9-17; Vienna, Austria. Abs P1131
  8. Owen R, McCarthy H, Rule S, et al. Acalabrutinib in Treatment-Naive or Relapsed/Refractory Waldenström Macroglobulinemia: 5-Year Follow-up of a Phase 2, Single-Arm Study [abstract and poster]. Presented at: EHA Congress; June 9-17; Vienna, Austria. Abs P1130
  9. Strati P, Coleman M, Stevens D, et al. Acalabrutinib in Patients With Relapsed/Refractory (R/R) Marginal Zone Lymphoma (MZL): Results of a Phase 2, Multicenter, Open-label Trial [abstract and poster]. Presented at: EHA Congress; June 9-17; Vienna, Austria. Abs P1129

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