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2022-11-30

AstraZeneca showcases strength of haematology portfolio and pipeline across multiple hard-to-treat conditions at ASH 2022

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.

AstraZeneca will present 47 abstracts showcasing new data from across its haematology portfolio and clinical pipeline, demonstrating its commitment to redefining care for hard-to-treat blood diseases at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition, 10 to 13 December 2022.

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.

Anas Younes, Senior Vice President, Haematology R&D, AstraZeneca, said: "At this year's ASH Annual Meeting, our data demonstrate the broad potential of our haematology pipeline and the continued strength of our approved medicines. Data are being highlighted from many of our early-stage molecules, including clinical trials of TNB-486 (AZD0486), a B-cell targeting T-cell engager, and presentations of long-term follow-up data will show the consistent safety and efficacy profile of Calquence."

Gianluca Pirozzi, Senior Vice President, Head of Development and Safety, Alexion, AstraZeneca Rare Disease, said: "The depth and breadth of Alexion data at this year's ASH Annual Meeting reinforce the importance of earlier diagnosis and disease management for rare diseases that are often not well-understood. We will share research across several therapy areas - including an oral presentation demonstrating the potential of vemircopan, an investigational, second-generation factor D inhibitor as monotherapy treatment of paroxysmal nocturnal haemoglobinuria - underscoring our leadership and unwavering commitment to driving critical innovations in rare disease."

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 Dana-Farber Cancer Institute will show the efficacy and tolerability of Calquence combined with venetoclax and obinutuzumab in a front-line, high-risk CLL population.4
  • 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 CAEL-101, a potentially first-in-class monoclonal antibody, in adults with AL amyloidosis.16
  • 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 Abstract # 4431
the Phase 1/2
Study of Poster Session: 642. Chronic Lymphocytic
Acalabrutinib Leukemia: Clinical and Epidemiological:
Monotherapy in Poster III
Treatment-Naive
Chronic 12 December 2022
Lymphocytic
Leukemia with >6 18:00-20:00 CST
Years of Follow
-Up Location: Hall D (Ernest N. Morial
Convention Center)
Davids, MS Contribution of Abstract # 1815
Obinutuzumab to
Acalabrutinib Poster Session: 642. Chronic Lymphocytic
Therapy in Leukemia: Clinical and Epidemiological:
Patients with Poster I
Treatment-Naive
Chronic 10 December 2022
Lymphocytic
Leukemia: 17:30-19:30 CST
Analysis of
Survival Outcomes Location: Hall D (Ernest N. Morial
by Genomic Convention Center)
Features
Davies, AJ Durable Responses Abstract # 4265
from
Acalabrutinib in Poster Session: 626. Aggressive Lymphomas:
Combination with Prospective Therapeutic Trials: Poster III
Rituximab,
Cyclophosphamide, 12 December 2022
Doxorubicin,
Vincristine and 18:00-20:00 CST
Prednisolone (R
-CHOP) as First Location: Hall D (Ernest N. Morial
Line Therapy for Convention Center)
Patients with
Diffuse Large B
-Cell Lymphoma
(DLBCL): The
ACCEPT Phase
Ib/II Single Arm
Study
Furman, R Phase 1/2 Study Abstract # 4434
of Acalabrutinib
Monotherapy in Poster Session: 642. Chronic Lymphocytic
Patients with Leukemia: Clinical and Epidemiological:
Relapsed/Refractor Poster III
y Chronic
Lymphocytic 12 December 2022
Leukemia: Final
Results with >4 18:00-20:00 CST
Years of Follow
-Up Location: Hall D (Ernest N. Morial
Convention Center)
Ruan, J Phase 2 Trial of Abstract # 73
Acalabrutinib
-Lenalidomide Oral Session: 623. Mantle Cell,
-Rituximab (ALR) Follicular, and Other Indolent B Cell
with Real-Time Lymphomas: Clinical and Epidemiological I
Monitoring of MRD
in Patients with 10 December 2022
Treatment-Naïve
Mantle Cell 9:30 CST
Lymphoma
Location: La Nouvelle Orleans Ballroom C
(Ernest N. Morial Convention Center)
Ryan, CE Updated Results Abstract # 344
from a
Multicenter, Oral Session: 642. Chronic Lymphocytic
Phase 2 Study of Leukemia: Clinical and Epidemiological:
Acalabrutinib, Targeted Triplet Combinations and
Venetoclax, Richter's Transformation
Obinutuzumab
(AVO) in a 10 December 2022
Population of
Previously 16:15 CST
Untreated
Patients with CLL Location: R06-R09 (Ernest N. Morial
Enriched for High Convention Center)
-Risk Disease
Seymour, JF Assessing the Abstract # 3133
Burden of Adverse
Events in a Head Poster Session: 642. Chronic Lymphocytic
-to-Head Trial of Leukemia: Clinical and Epidemiological:
Acalabrutinib Poster II
Versus Ibrutinib
in Previously 11 December 2022
Treated Chronic
Lymphocytic 18:00-20:00 CST
Leukemia (CLL)
Location: Hall D (Ernest N. Morial
Convention Center)
AZD0486
(CD19/CD3 T
-cell engager)
Hou, JZ Interim Results Abstract # 612
of the Phase 1
Study of Tnb-486, Oral Session: 623. Mantle Cell,
a Novel CD19xCD3 Follicular, and Other Indolent B Cell
T-Cell Engager, Lymphomas: Clinical and Epidemiological IV
in Patients with
Relapsed/Refractor 11 December 2022
y (R/R) B-NHL
17:45 CST

Location: 278-282 (Ernest N. Morial
Convention Center)
AZD0466 (Bcl
-2/Bcl-xL
inhibitor)
Arslan, S Safety and Abstract # 4094
Tolerability of
AZD0466 as Poster Session: 616. Acute Myeloid
Monotherapy for Leukemias: Investigational Therapies,
Patients with Excluding Transplantation and Cellular
Advanced Immunotherapies: Poster III
Hematological
Malignancies. 12 December 2022
Preliminary
Results from an 18:00-20:00 CST
Ongoing Phase
I/II Trial Location: Hall D (Ernest N. Morial
Convention Center)
AZD4573 (CDK9
inhibitor)
Brümmendorf, T Safety, Abstract # 1353
Tolerability,
Pharmacokinetics Poster Session: 605. Molecular
(PK) and Pharmacology and Drug Resistance: Lymphoid
Preliminary Neoplasms: Poster I
Antitumor
Activity of the 10 December 2022
Cyclin-Dependent
Kinase-9 (CDK9) 17:30-19:30 CST
Inhibitor AZD4573
in Location: Hall D (Ernest N. Morial
Relapsed/Refractor Convention Center)
y Hematological
Malignancies: A
Phase 1 First-in
-Human Study
Strati, P Phase 1b/2a Study Abstract # 2962
of AZD4573
(CDK9i) and Poster Session: 627. Aggressive Lymphomas:
Acalabrutinib in Clinical and Epidemiological: Poster II
Patients with
Relapsed/Refractor 11 December 2022
y Diffuse ...

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