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
A total of five approved and potential new medicines from
Christophe Hotermans, MD, PhD, Senior Vice President, Global Medical Affairs, Alexion, said: "The collective clinical and real-world data being presented at the
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
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 Presentation
Poster Session
Ghia, P
Acalabrutinib vs Rituximab Plus Idelalisib or Bendamustine in Relapsed/Refractory Chronic Lymphocytic Leukemia: ASCEND Results at ~4 Years of Follow-up
Abstract # P668
Poster Presentation
Poster Session
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 # P667
Poster Presentation
Poster Session
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
Le Gouill, S
Post Hoc Analysis of Patients With Highly Proliferative Variants of Mantle Cell Lymphoma Treated With Acalabrutinib
Abstract # P1131
Poster Presentation
Poster Session
Owen, R
Acalabrutinib in Treatment-Naive or Relapsed/Refractory Waldenström Macroglobulinemia: 5-Year Follow-up of a Phase 2, Single-Arm Study
Abstract # P1130
Poster Presentation
Poster Session
Strati, P
Acalabrutinib in Patients With Relapsed/Refractory (R/R) Marginal Zone Lymphoma (MZL): Results of a Phase 2, Multicenter, Open-label Trial
Abstract # P1129
Poster Presentation
Poster Session
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 # P812
Poster Presentation
Poster Session
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 # P813
Poster Presentation
Poster Session
Soliris (eculizumab)
Nishimura, J
Real-World Outcomes of Eculizumab Treatment in Patients with Paroxysmal Nocturnal Hemoglobinurea: A Systematic Literature Review and Evidence Synthesis
Abstract # PB1934
e-Publication
Online Only
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 # P834
Poster Presentation
Poster Session
ALXN1820
Kim, S
Properdin-Blocking Antibodies Attenuate Complement Alternative Pathway Activation Triggered by Cell-Free Heme in Sickle Cell Disease Models
Abstract # S267
Oral Presentation
Session - Sickle Cell Disease: Novel Biomarkers and Therapies
Notes
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.
The Company's focus is on some of the most challenging cancers. It is through persistent innovation that
Alexion
Alexion, AstraZeneca Rare Disease, is the group within
Contacts
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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:
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:
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:
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:
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:
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:
7. Le Gouill S, Dlugosz-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:
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:
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:
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