ASTRAZENECA PLC * Calquence real-world evidence and long-term follow-up data, as well as research collaborations, will reinforce efficacy and safety across B-cell malignancies
* Early clinical data will illustrate potential of multiple pipeline molecules, including TNB-486 (AZD0486), across haematologic malignancies
* Research from Alexion, AstraZeneca Rare Disease, offers new insights to accelerate innovation and improve time to diagnosis for several rare diseases
A total of eight approved and potential new medicines will be featured across more than ten types of blood cancers and rare diseases, including data in chronic lymphocytic leukaemia (CLL), follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), paroxysmal nocturnal haemoglobinuria (PNH), atypical haemolytic uraemic syndrome (aHUS) and amyloid light chain (AL) amyloidosis.
Calquence (acalabrutinib) real-world evidence and long-term follow-up data support consistent efficacy and safety profile
A post-hoc safety analysis from the head-to-head ELEVATE-RR Phase III trial of Calquence versus ibrutinib will further support tolerability differences of Calquence in relapsed or refractory CLL.1
Final long-term follow-up results of the Phase I/II trials evaluating Calquence monotherapy in front-line and relapsed or refractory CLL will further support the continued efficacy and safety Calquence demonstrated in both settings.2,3
An oral presentation of Phase II research sponsored by the
A retrospective pooled analysis will show the benefit of adding obinutuzumab to Calquence in the front-line CLL setting in patients with select genomic characteristics.5
An oral presentation of preliminary Phase II results sponsored by Weill Cornell Medicine will show that Calquence combined with lenalidomide and rituximab is generally well-tolerated, highly effective and produces high rates of minimal residual disease-negative complete remission in front-line MCL.6
Novel treatment strategies with emerging pipeline molecules exhibit therapeutic potential
An oral presentation of interim Phase I results evaluating TNB-486 (AZD0486), a CD19/CD3 next generation bispecific T-cell engager, will show the potential of targeting CD19/CD3, leading to an increase in anti-cancer activity in heavily pretreated patients with B-cell non-Hodgkin lymphoma (NHL).7
Results from Phase I and II trials of CDK9 inhibitor AZD4573 alone and with Calquence will exhibit data on tolerability across a broad range of haematologic malignancies, including relapsed or refractory DLBCL.8,9
Preliminary results from an ongoing Phase I trial will demonstrate that Bcl-2/Bcl-xl inhibitor AZD0466 has been well-tolerated in patients with advanced haematologic malignancies.10
Innovating to help address the treatment needs of all patients with PNH
An oral presentation detailing interim results from a Phase II open-label trial of vemircopan (ALXN2050) will highlight efficacy and safety data from the treatment-naïve patient group, establishing proof-of-concept as a monotherapy for PNH.11
An interim analysis from an ongoing Phase IV trial assessing the impact of switching to standard, weight-based intravenous (i.v.) Ultomiris (ravulizumab) from high-dose i.v. Soliris (eculizumab) in adults with PNH will be presented.12
Improving diagnosis and management of life-threatening rare diseases
An analysis of data from the Global aHUS Registry, which contains information on patients across more than 100 sites in more than 20 countries, will highlight the importance of considering aHUS as a diagnosis even in the presence of a triggering condition or associated event.13
An analysis of real-world patient data from the US Premier Healthcare Database will expand on the potential of the PLASMIC scoring system to aid in identifying people with aHUS and making earlier treatment decisions.14
An analysis of paediatric patients with haematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) will provide insights on the correlation between complement activation and endothelial damage in HSCT-TMA and the potential for useful biomarkers indicative of this damage to inform diagnosis.15
Results through one year on safety, tolerability and biomarker data will be presented from a Phase II trial evaluating
A real-world analysis in a current population with AL amyloidosis using Komodo Health US claims data will highlight the need for greater awareness and understanding to accelerate time to diagnosis.17
Key presentations during the 64th ASH Annual Meeting and Exposition
Lead author
Abstract title
Presentation details
Calquence (acalabrutinib)
Byrd, J
Final Results of the Phase 1/2 Study of Acalabrutinib Monotherapy in Treatment-Naive Chronic Lymphocytic Leukemia with >6 Years of Follow-Up
Abstract # 4431
Poster Session: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster III
Location: Hall D (
Davids, MS
Contribution of Obinutuzumab to Acalabrutinib Therapy in Patients with Treatment-Naive Chronic Lymphocytic Leukemia: Analysis of Survival Outcomes by Genomic Features
Abstract # 1815
Poster Session: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster I
Location: Hall D (
Davies, AJ
Durable Responses from Acalabrutinib in Combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisolone (R-CHOP) as First Line Therapy for Patients with Diffuse Large B-Cell Lymphoma (DLBCL): The ACCEPT Phase Ib/II Single Arm Study
Abstract # 4265
Poster Session: 626. Aggressive Lymphomas: Prospective Therapeutic Trials: Poster III
Location: Hall D (
Furman, R
Phase 1/2 Study of Acalabrutinib Monotherapy in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia: Final Results with >4 Years of Follow-Up
Abstract # 4434
Poster Session: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster III
Location: Hall D (
Ruan, J
Phase 2 Trial of Acalabrutinib-Lenalidomide-Rituximab (ALR) with Real-Time Monitoring of MRD in Patients with Treatment-Naïve Mantle Cell Lymphoma
Abstract # 73
Location: La Nouvelle Orleans Ballroom C (
Ryan, CE
Updated Results from a Multicenter, Phase 2 Study of Acalabrutinib, Venetoclax, Obinutuzumab (AVO) in a Population of Previously Untreated Patients with CLL Enriched for High-Risk Disease
Abstract # 344
Location: R06-R09 (
Seymour, JF
Assessing the Burden of Adverse Events in a Head-to-Head Trial of Acalabrutinib Versus Ibrutinib in Previously Treated Chronic Lymphocytic Leukemia (CLL)
Abstract # 3133
Poster Session: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster II
Location: Hall D (
AZD0486 (CD19/CD3 T-cell engager)
Hou, JZ
Interim Results of the Phase 1 Study of Tnb-486, a Novel CD19xCD3 T-Cell Engager, in Patients with Relapsed/Refractory (R/R) B-NHL
Abstract # 612
Location: 278-282 (
AZD0466 (Bcl-2/Bcl-xL inhibitor)
Arslan, S
Safety and Tolerability of AZD0466 as Monotherapy for Patients with Advanced Hematological Malignancies. Preliminary Results from an Ongoing Phase I/II Trial
Abstract # 4094
Poster Session: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster III
Location: Hall D (
AZD4573 (CDK9 inhibitor)
Brümmendorf, T
Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Antitumor Activity of the Cyclin-Dependent Kinase-9 (CDK9) Inhibitor AZD4573 in Relapsed/Refractory Hematological Malignancies: A Phase 1 First-in-Human Study
Abstract # 1353
Poster Session: 605.
Location: Hall D (
Strati, P
Phase 1b/2a Study of AZD4573 (CDK9i) and Acalabrutinib in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (r/r DLBCL): Results from Dose-Escalation
Abstract # 2962
Poster Session: 627. Aggressive Lymphomas: Clinical and Epidemiological: Poster II
Location: Hall D (
Vemircopan (ALXN2050)
Browett, P
Vemircopan (ALXN2050) Monotherapy in Paroxysmal Nocturnal Hemoglobinuria: Interim Data from a Phase 2 Open-Label Proof-of-Concept Study
Abstract # 294
Location: 260-262 (
Ultomiris (ravulizumab)
Griffin, M
Terminal Complement Inhibition and Control of Hemolysis in Paroxysmal Nocturnal Hemoglobinuria Following Switching from High-Dose Eculizumab to Ravulizumab: An Interim Analysis
Abstract # 1251
Poster Session: 508. Bone Marrow Failure: Acquired: Poster I
Location: Hall D (
ALXN1820
Dai, Y
A Phase 2a, Randomized, Open-Label Study to Evaluate Multiple Dosing Regimens of Subcutaneous ALXN1820 in Adult Patients with Sickle Cell Disease
Abstract # 3713
Poster Session: 114. Hemoglobinopathies, Excluding Thalassemia: Clinical and Epidemiological: Poster III
Location: Hall D (
Valent, J
1-Year Results from a Phase 2 Study to Determine Safety and Tolerability of Treating Patients with Light-Chain (AL) Amyloidosis with
Abstract # 4550
Poster Session: 653. Myeloma and Plasma Cell Dyscrasias: Prospective Therapeutic Trials: Poster III
Location: Hall D (
AL Amyloidosis
Catini, J
Evaluation of the Path to Diagnosis and Time to Treatment in Patients with Light-Chain Amyloidosis Using the Komodo Claims Database
Abstract # 1887
Poster Session: 652. Multiple Myeloma and Plasma Cell Dyscrasias: Clinical and Epidemiological: Poster I
Location: Hall D (
HSCT-TMA
Jacobi, P
Complement Activation is Associated
with Endothelial Damage in
Hematopoietic Stem Cell Transplant
Associated-Thrombotic Microangiopathy
Abstract # 2431
Poster Session: 301. Vasculature, Endothelium, Thrombosis and Platelets: Basic and Translational: Poster II
Location: Hall D (
aHUS
Gasteyger, C
Use of PLASMIC Scores to Aid Diagnosis of aHUS: A Real-World Analysis of Hospitalized Patients from the Premier Healthcare Database
Abstract # 1178
Poster Session: 331. Thrombotic Microangiopathies/Thrombocytopenias and COVID-19-related Thrombotic/Vascular Disorders: Clinical and Epidemiological: Poster I
Location: Hall D (
Siedlecki, A
Characterization of Patients with aHUS and Triggering/Associated Events, with and without Complement Pathogenic Variants or anti-CFH Antibodies: A Global aHUS Registry Analysis
Abstract # 1173
Poster Session: 331. Thrombotic Microangiopathies/Thrombocytopenias and COVID-19-related Thrombotic/Vascular Disorders: Clinical and Epidemiological: Poster I
Location: Hall D (
Notes
By targeting haematologic 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
For details on how to contact the Investor Relations Team, please click here. For media contacts, click here.
References
1. Seymour JF, Byrd JC, Munir T, et al. Assessing the Burden of Adverse Events in a Head-to-Head Trial of Acalabrutinib Versus Ibrutinib in Previously Treated Chronic Lymphocytic Leukemia (CLL) [abstract and poster]. Presented at:
2. Byrd JC, Woyach JA, Furman RR, et al. Final Results of the Phase 1/2 Study of Acalabrutinib Monotherapy in Treatment-Naive Chronic Lymphocytic Leukemia with >6 Years of Follow-up [abstract and poster]. Presented at:
3. Furman RR, Wierda WG, Schuh A, et al. Phase 1/2 Study of Acalabrutinib Monotherapy in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia: Final Results with >4 Years of Follow-up [abstract and poster]. Presented at:
4. Ryan CE, Lampson BL, Tyekucheva, S, et al. Updated Results from a Multicenter, Phase 2 Study of Acalabrutinib, Venetoclax, Obinutuzumab (AVO) in a Population of Previously Untreated Patients with CLL Enriched for High-Risk Disease [abstract and oral]. Presented at:
5. Davids MS, Sharman JP, Eyre TA, et al. Contribution of Obinutuzumab to Acalabrutinib Therapy in Patients with Treatment-Naive Chronic Lymphocytic Leukemia: Analysis of Survival Outcomes by Genomic Features [abstract and poster]. Presented at:
6. Ruan J, Leonard JP, Chen GZ, et al. Phase 2 Trial of Acalabrutinib-Lenalidomide-Rituximab (ALR) with Real-Time Monitoring of MRD in Patients with Treatment-Naïve Mantle Cell Lymphoma [abstract and oral]. Presented at:
7. Hou JZ, Jacobs R, Cho SG, et al. Interim Results of the Phase 1 Study of Tnb-486, a Novel CD19xCD3 T-Cell Engager, in Patients with Relapsed/Refractory (R/R) B-NHL [abstract and oral]. Presented at:
8. Brümmendorf T, Medd P, Koch R, et al. Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Antitumor Activity of the Cyclin-Dependent Kinase-9 (CDK9) Inhibitor AZD4573 in Relapsed/Refractory Hematological Malignancies: A Phase 1 First-in-Human Study [abstract and poster]. Presented at:
9. Strati P, Kim TM, Danilov A, et al. Phase 1b/2a Study of AZD4573 (CDK9i) and Acalabrutinib in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (r/r DLBCL): Results from Dose-Escalation [abstract and poster]. Presented at:
10. Arslan S, Fleming S, Jain N, et al. Safety and Tolerability of AZD0466 as Monotherapy for Patients with Advanced Hematological Malignancies. Preliminary Results from an Ongoing Phase I/II Trial [abstract and poster]. Presented at:
11. Browett P, Kulasekararaj A, Notaro R, et al. Vemircopan (ALXN2050) Monotherapy in Paroxysmal Nocturnal Hemoglobinuria: Interim Data from a Phase 2 Open-Label Proof-of-Concept Study [abstract and oral]. Presented at:
12. Griffin M, Gandhi S, Hicks E, et al. Terminal Complement Inhibition and Control of Hemolysis in Paroxysmal Nocturnal Hemoglobinuria Following Switching from High-Dose Eculizumab to Ravulizumab: An Interim Analysis [abstract and poster]. Presented at:
13. Siedlecki A, Al-Dakkak I, Anokhina K, et al. Characterization of Patients with aHUS and Triggering/Associated Events, with and without Complement Pathogenic Variants or Anti-CFH Antibodies: A Global aHUS Registry Analysis [abstract and poster]. Presented at:
14. Gasteyger C,
15. Jacobi P, Cofiell R, Chang CH, et. al. Complement Activation is Associated with Endothelial Damage in Hematopoietic Stem Cell Transplant Associated-Thrombotic Microangiopathy [abstract and poster]. Presented at:
16. Valent J, Liedtke M, Zonder J, et al. 1-Year Results from a Phase 2 Study to Determine Safety and Tolerability of Treating Patients with Light-Chain (AL) Amyloidosis with
17. Catini J, Doan Q, Evans J, et al. Evaluation of the Path to Diagnosis and Time to Treatment in Patients with Light-Chain Amyloidosis Using the Komodo Claims Database [abstract and poster]. Presented at:
.
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