AstraZeneca advances scientific leadership in hematology at ASH 2023

CALQUENCE six-year follow-up data reinforce long-term benefit in chronic lymphocytic leukemia, and data across multiple hematology assets showcase breadth of promising early pipeline

New, longer-term data from ALPHA Phase III trial will further show potential of danicopan to address clinically significant extravascular hemolysis and maintain disease control, allowing paroxysmal nocturnal hemoglobinuria patients to continue standard-of-care treatment with ULTOMIRIS or SOLIRIS

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca will present new clinical and real-world data in multiple hematological conditions at the 65th American Society of Hematology (ASH) Annual Meeting andExposition, December 9 to 12, 2023 in San Diego, CA.


A total of 63 abstracts will feature 14 approved and potential new medicines across the Company’s portfolio and pipeline including from Alexion, AstraZeneca’s Rare Disease group, in chronic lymphocytic leukemia (CLL) and several types of lymphoma, paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS) and amyloid light-chain (AL) amyloidosis.

Anas Younes, Senior Vice President, Hematology R&D, AstraZeneca, said: “Our data at ASH will exemplify how we are advancing a range of innovative modalities including antibody drug conjugates, next-generation immunotherapies and T-cell engagers in hematology. Updated clinical data for AZD0486, our CD19/CD3 T-cell engager, reinforce our belief in this approach as a potential new treatment for lymphoma, and new CALQUENCE data continue to demonstrate long-term efficacy and safety in chronic lymphocytic leukemia with further follow up.”

Gianluca Pirozzi, Senior Vice President, Head of Development, Regulatory and Safety, Alexion, said: “Alexion has transformed the treatment landscape and redefined care for the paroxysmal nocturnal hemoglobinuria patient community over the past two decades. At the ASH Annual Meeting, new results from our pivotal ALPHA trial will demonstrate the promise of Factor D inhibition to advance care for the small subset of patients with paroxysmal nocturnal hemoglobinuria who experience clinically significant extravascular hemolysis. We are proud to further our leadership in rare disease by sharing data from our robust hematology pipeline, reflecting our commitment to innovation and improving outcomes for the patients and families we serve.”

CALQUENCE® (acalabrutinib) continues to demonstrate long-term benefits in CLL

Six-year follow-up data from the pivotal ELEVATE-TN Phase III trial will further support the continued efficacy, safety and tolerability of CALQUENCE for long-term use in patients with treatment-naïve CLL.1

Data from a Phase II trial will show the safety and efficacy of CALQUENCE and rituximab followed by chemotherapy and autologous stem cell transplantation in fit patients with treatment-naïve mantle cell lymphoma (MCL).2

An analysis of five prospective CALQUENCE trials, including three randomized, controlled Phase III trials and two non-randomized trials, will show acceptable safety outcomes based on rates of nonfatal and fatal ventricular arrhythmias and sudden death in patients with CLL.3

Novel early assets show potential to improve outcomes for blood cancer patients

Data from our early portfolio will demonstrate how the Company is advancing multiple modalities across several scientific platforms, including Immuno-Oncology, Immune-Engagers, Antibody Drug Conjugates (ADCs) and Epigenetics as part of its strategy to attack cancer from multiple angles.

Updated Phase I data for AstraZeneca’s CD19/CD3 T-cell engager, AZD0486, will further demonstrate the acceptable safety profile and high response rate of this treatment in relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (NHL).4 We will also present the first clinical data on sabestomig, a PD-1/TIM-3 targeting bispecific antibody, in R/R Hodgkin lymphoma, showing encouraging early signals of activity.5

The first preclinical data for AZD9829, a novel CD123-targeting ADC, using AstraZeneca’s proprietary linker technology to deliver a topoisomerase I inhibitor warhead, will demonstrate promising anti-tumor activity in acute myeloid leukemia.6 In addition, preclinical data will demonstrate anti-tumor activity of AstraZeneca’s novel PRMT5 inhibitor in MTAP silenced Hodgkin lymphoma models.7

Showcasing advances to bolster our leadership in PNH with new data on Factor D inhibition and impact of C5 inhibition in long-term disease control

New results from the 24-week and long-term extension period from the pivotal ALPHA Phase III trial will reinforce the potential for danicopan add-on therapy to address clinically significant extravascular hemolysis (EVH) in the small subset of PNH patients who experience this condition while treated with C5 inhibitor therapy, allowing them to maintain control of intravascular hemolysis (IVH) through standard-of-care treatment with ULTOMIRIS® (ravulizumab-cwvz) or SOLIRIS® (eculizumab).8

Further, patient-reported outcomes from the ALPHA trial will suggest danicopan as an add-on to ULTOMIRIS or SOLIRIS improved quality of life compared to C5 inhibitor therapy alone in patients with PNH who experience clinically significant EVH.9

Additionally, Alexion will present an analysis of six-year outcomes from the Phase III clinical trial evaluating the safety and efficacy of ULTOMIRIS in patients with PNH who did not have previous treatment with a C5 inhibitor.10 The analysis compared survival against untreated patients in the International PNH Registry, the largest global real-world database of patients with PNH. Results will suggest ULTOMIRIS improved survival and maintained effective long-term control of IVH, the most significant contributor to morbidity and premature mortality in PNH.10

Improving diagnosis and management of life-threatening rare diseases, including amyloidosis

24-month results of a Phase II trial will demonstrate the safety and tolerability of CAEL-101 in combination with cyclophosphamide-bortezomib-dexamethasone with or without daratumumab for the treatment of AL amyloidosis.11

Real-world analyses across AL amyloidosis, aHUS and hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) will also be presented, advancing the scientific understanding of these rare, hematological conditions.12-16

Key presentations during the 65th ASH Annual Meeting and Exposition

Lead author

Abstract title

Presentation details

CALQUENCE (acalabrutinib)

 

Sharman, JP

Acalabrutinib ± Obinutuzumab vs Obinutuzumab + Chlorambucil in Treatment-naive Chronic Lymphocytic Leukemia: 6-year Follow-up of ELEVATE-TN

 

 

Abstract # 636

Oral Session: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Frontline Treatment with Targeted Agents in Patients with Chronic Lymphocytic Leukemia

December 10, 2023

17:45 PST

Location: Seaport Ballroom ABCD (Manchester Grand Hyatt San Diego)

Westin, J

Smart Stop: Lenalidomide, Tafasitamab, Rituximab and Acalabrutinib Alone and with Combination Chemotherapy for the Treatment of Newly Diagnosed Diffuse Large B-cell Lymphoma

 

Abstract # 856

Oral Session: 626. Aggressive Lymphomas: Prospective Therapeutic Trials: Initial Treatment Strategies in Aggressive B-Cell Lymphomas

December 11, 2023

15:30 PST

Location: Seaport Ballroom ABCD (Manchester Grand Hyatt San Diego)

Hawkes, EA

A Window Study of Acalabrutinib and Rituximab, Followed by Chemotherapy and Autograft (ASCT) in Fit Patients with Treatment-naïve Mantle Cell Lymphoma (MCL): First Report of the Investigator-initiated Australasian Leukemia and Lymphoma Group NHL33 ‘WAMM’ Trial

 

Abstract # 735

Oral Session: 623. Mantle Cell, Follicular and Other Indolent B-Cell Lymphomas: Clinical and Epidemiological: Prospective Clinical Trials in Mantle Cell Lymphoma Incorporating Novel Agents

December 11, 2023

11:00 PST

Location: Grand Hall B (Manchester Grand Hyatt San Diego)

Hawkes, EA

TrAVeRse: A Phase 2, Open-Label, Randomized Study of Acalabrutinib in Combination with Venetoclax and Rituximab in Patients with Treatment- naïve Mantle Cell Lymphoma

 

Abstract # 3054

Poster Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphomas: Clinical and Epidemiological: Poster II

December 10, 2023

18:00 – 20:00 PST

Location: Halls G-H (San Diego Convention Center)

Sharman, J

Analysis of Ventricular Arrhythmias and Sudden Death with Acalabrutinib From 5 Prospective Clinical Trials

 

 

Abstract # 4643

Poster Session: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster III

December 11, 2023

18:00 – 20:00 PST

Location: Halls G-H (San Diego Convention Center)

Ferrajoli, A

Cumulative Review of Hypertension in Patients with Chronic Lymphocytic Leukemia (CLL) and Other Hematologic Malignancies Treated with Acalabrutinib: Data from Clinical Trials

 

 

Abstract # 1917

Poster Session: 642. Chronic Lymphocytic Leukemia: Clinical and

Epidemiological: Poster I

December 9, 2023

17:30 – 19:30 PST

Location: Halls G-H (San Diego Convention Center)

Sun, C

Extended Follow-Up and Resistance Mutations in CLL Patients Treated with Acalabrutinib

Abstract # 1891

Poster Session: 641. Chronic Lymphocytic Leukemias: Basic and Translational: Poster I

December 9, 2023

17:30 – 19:30 PST

Location: Halls G-H (San Diego Convention Center)

Jain, P

Acalabrutinib with Rituximab as First-line Therapy for Older Patients with Mantle Cell Lymphoma – A Phase II Clinical Trial

Abstract # 3036

Poster Session: 623. Mantle Cell, Follicular, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster II

December 10, 2023

18:00 – 20:00 PST

Location: Halls G-H (San Diego Convention Center)

Perini, G

ACRUE: A Phase 2, Open-label Study of Acalabrutinib in Combination with Rituximab in Elderly and/or Frail Patients with Treatment-naïve Diffuse Large B-Cell Lymphoma

e-Publication

Online Only

AZD0486

 

Gaballa, S

Double Step-Up Dosing (2SUD) Regimen Mitigates Severe ICANS and CRS While Maintaining a High Efficacy in Subjects with Relapsed/Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL) Treated with AZD0486, a Novel CD19xCD3 T-cell Engager (TCE): Updated Safety and Efficacy Data from the Ongoing First-in-Human (FIH) Phase I Trial

Abstract # 1662

Poster Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphomas: Clinical and Epidemiological: Poster I

December 9, 2023

17:30 – 19:30 PST

Location: Halls G-H (San Diego Convention Center)

AZD9829

Dutta, D

First Disclosure of AZD9829, a TOP1i-ADC Targeting CD123: Promising Preclinical Activity in AML Models with Minimal Effect on Healthy Progenitors

e-Publication

Online Only

 

AZD7789

Mei, M

Safety and Preliminary Efficacy of Sabestomig (AZD7789), an Anti-PD-1 and Anti-TIM-3 Bispecific Antibody, in Patients with Relapsed or Refractory Classical Hodgkin Lymphoma Previously Treated with Anti-PD-(L)1 Therapy

 

Abstract # 4433

Poster Session: 624. Hodgkin Lymphomas and T/NK cell Lymphomas: Clinical and Epidemiological: Poster III

December 11, 2023

18:00 – 20:00 PST

Location: Halls G-H (San Diego Convention Center)

PRMT5 inhibitor

Urosevic, J

Epigenetic Silencing of MTAP in Hodgkin’s Lymphoma Renders it Sensitive to a 2nd Generation PRMT5 Inhibitor

 

Abstract # 4185

Poster Session: 605. Molecular Pharmacology and Drug Resistance: Lymphoid Neoplasms: Poster III

December 11, 2023

18:00 – 20:00 PST

Location: Halls G-H (San Diego Convention Center)

Danicopan

Kulasekararaj, A

Danicopan as Add-On Therapy to Ravulizumab or Eculizumab Versus Placebo in Patients with Paroxysmal Nocturnal Hemoglobinuria and Clinically Significant Extravascular Hemolysis: Phase 3 Long-term Data

Abstract # 576

Oral Session: 508. Bone Marrow Failure: Acquired: Unraveling the Future of PNH Therapy from Clinical Trials

December 10, 2023

17:45 PST

Location: Room 7 (San Diego Convention Center)

Piatek, C

Patient-reported Outcomes: Danicopan as Add-On Therapy to Ravulizumab or Eculizumab Versus Placebo in Patients with Paroxysmal Nocturnal Hemoglobinuria and Clinically Significant Extravascular Hemolysis

Abstract # 1346

Poster Session: 508. Bone Marrow Failure: Acquired: Poster I

December 9, 2023

17:30 – 19:30 PST

Location: Halls G-H (San Diego Convention Center)

ULTOMIRIS (ravulizumab-cwvz)

Kulasekararaj, A

Ravulizumab Provides Durable Control of Intravascular Hemolysis and Improves Survival in Patients with Paroxysmal Nocturnal Hemoglobinuria: Long-Term Follow-Up of Study 301 and Comparisons with Patients of the International PNH Registry

Abstract # 2714

Poster Session: 508. Bone Marrow Failure: Acquired: Poster II

December 10, 2023

18:00 – 20:00 PST

Location: Halls G-H (San Diego Convention Center)

Röth, A

Ravulizumab Effectiveness in the Real-world: Evidence from the International PNH Registry

Abstract # 2722

Poster Session: 508. Bone Marrow Failure: Acquired: Poster II

December 10, 2023

18:00 – 20:00 PST

Location: Halls G-H (San Diego Convention Center)

Piatek, C

Efficacy and Safety of Subcutaneous Ravulizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria Who Received Prior Intravenous Eculizumab: 2-Year Follow-Up

Abstract # 2713

Poster Session: 508. Bone Marrow Failure: Acquired: Poster II

December 10, 2023

18:00 – 20:00 PST

Location: Halls G-H (San Diego Convention Center)

CAEL-101

Valent, J

Safety and Tolerability of CAEL-101, an Anti-Amyloid Monoclonal Antibody, Combined with Anti-Plasma Cell Dyscrasia Therapy in Patients with Light-Chain Amyloidosis: 24-Month Results of a Phase 2 Study

Abstract # 540

Oral Session: 654. MGUS, Amyloidosis and Other Non-Myeloma Plasma Cell Dyscrasias: Clinical and Epidemiological: From Light Chain to Fibril–Novel Diagnostics to Treatments for Amyloidosis

December 10, 2023

13:15 PST

Location: Seaport Ballroom EFGH (Manchester Grand Hyatt San Diego)

Costello, M

CAEL-101 Enhances the Clearance of Light Chain Fibrils and Intermediate Aggregates by Phagocytosis

Abstract # 3307

Poster Session: 651. Multiple Myeloma and Plasma Cell Dyscrasias: Basic and Translational: Poster II

December 10, 2023

18:00 – 20:00 PST

Location: Halls G-H (San Diego Convention Center)

AL Amyloidosis

Lyons, G

Treatment Patterns and Outcomes for Patients with Light Chain (AL) Amyloidosis: Analysis of a Large US Claims Database

e-Publication

Online Only

Thompson, J

Real-world Treatment Patterns Following Update to National Comprehensive Cancer Network Guidelines for Light-Chain Amyloidosis: Results from a US Administrative Claims Database

e-Publication

Online Only

Laires, P

Prevalence, Incidence, and Characterization of Light Chain Amyloidosis in the USA: A Real-world Analysis Utilizing Electronic Health Records (EHR)

e-Publication

Online Only

aHUS

Wang, Y

Patient Characteristics and Diagnostic Journey of Thrombotic Microangiopathy Associated with a Trigger: A Real-world, Retrospective, Multi-national Study

e-Publication

Online Only

HSCT-TMA

Wang, Y

Real-World Analysis of the Underdiagnosis, Clinical Outcomes and Associated Burden of Hematopoietic Stem Cell Transplantation-Associated Thrombotic Microangiopathy (HSCT-TMA) in the United States of America

Abstract # 491

Oral Session: 904. Outcomes Research – Non-Malignant Conditions: What to Know: Management Costs and Outcomes in Various Non-Malignant Disorders

December 10, 2023

10:30 PST

Location: Pacific Ballroom Salons 15-17 (Marriott Marquis San Diego Marina)

PNH

Wagner-Ballon, O

Neutrophil PNH Type II Cells Are Associated with Thrombosis and Bone Marrow Failure Without Hemolysis: Evidence from Analysis of the 5-year French Nation-Wide Multicenter Observational Study

Abstract # 4083

Poster Session: 508. Bone Marrow Failure: Acquired: Poster III

December 11, 2023

18:00 – 20:00 PST

Location: Halls G-H (San Diego Convention Center)

INDICATIONS AND USAGE

CALQUENCE is a Bruton tyrosine kinase (BTK) inhibitor indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

CALQUENCE is also indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

IMPORTANT SAFETY INFORMATION ABOUT CALQUENCE® (acalabrutinib) tablets

Serious and Opportunistic Infections

Fatal and serious infections, including opportunistic infections, have occurred in patients with hematologic malignancies treated with CALQUENCE.

Serious or Grade 3 or higher infections (bacterial, viral, or fungal) occurred in 19% of 1029 patients exposed to CALQUENCE in clinical trials, most often due to respiratory tract infections (11% of all patients, including pneumonia in 6%). These infections predominantly occurred in the absence of Grade 3 or 4 neutropenia, with neutropenic infection reported in 1.9% of all patients. Opportunistic infections in recipients of CALQUENCE have included, but are not limited to, hepatitis B virus reactivation, fungal pneumonia, Pneumocystis jirovecii pneumonia, Epstein-Barr virus reactivation, cytomegalovirus, and progressive multifocal leukoencephalopathy (PML). Consider prophylaxis in patients who are at increased risk for opportunistic infections. Monitor patients for signs and symptoms of infection and treat promptly.

Hemorrhage

Fatal and serious hemorrhagic events have occurred in patients with hematologic malignancies treated with CALQUENCE. Major hemorrhage (serious or Grade 3 or higher bleeding or any central nervous system bleeding) occurred in 3.0% of patients, with fatal hemorrhage occurring in 0.1% of 1029 patients exposed to CALQUENCE in clinical trials. Bleeding events of any grade, excluding bruising and petechiae, occurred in 22% of patients.

Use of antithrombotic agents concomitantly with CALQUENCE may further increase the risk of hemorrhage. In clinical trials, major hemorrhage occurred in 2.7% of patients taking CALQUENCE without antithrombotic agents and 3.6% of patients taking CALQUENCE with antithrombotic agents. Consider the risks and benefits of antithrombotic agents when co-administered with CALQUENCE. Monitor patients for signs of bleeding.

Consider the benefit-risk of withholding CALQUENCE for 3-7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding.

Cytopenias

Grade 3 or 4 cytopenias, including neutropenia (23%), anemia (8%), thrombocytopenia (7%), and lymphopenia (7%), developed in patients with hematologic malignancies treated with CALQUENCE. Grade 4 neutropenia developed in 12% of patients. Monitor complete blood counts regularly during treatment. Interrupt treatment, reduce the dose, or discontinue treatment as warranted.

Second Primary Malignancies

Second primary malignancies, including skin cancers and other solid tumors, occurred in 12% of 1029 patients exposed to CALQUENCE in clinical trials. The most frequent second primary malignancy was skin cancer, reported in 6% of patients. Monitor patients for skin cancers and advise protection from sun exposure.

Atrial Fibrillation and Flutter

Grade 3 atrial fibrillation or flutter occurred in 1.1% of 1029 patients treated with CALQUENCE, with all grades of atrial fibrillation or flutter reported in 4.1% of all patients. The risk may be increased in patients with cardiac risk factors, hypertension, previous arrhythmias, and acute infection. Monitor for symptoms of arrhythmia (eg, palpitations, dizziness, syncope, dyspnea) and manage as appropriate.

ADVERSE REACTIONS

The most common adverse reactions (≥20%) of any grade in patients with relapsed or refractory MCL were anemia,* thrombocytopenia,* headache (39%), neutropenia,* diarrhea (31%), fatigue (28%), myalgia (21%), and bruising (21%). The most common Grade ≥3 non-hematological adverse reaction (reported in at least 2% of patients) was diarrhea (3.2%).

*Treatment-emergent decreases (all grades) of hemoglobin (46%), platelets (44%), and neutrophils (36%) were based on laboratory measurements and adverse reactions.

Dose reductions or discontinuations due to any adverse reaction were reported in 1.6% and 6.5% of patients, respectively. Increases in creatinine to 1.5 to 3 times the upper limit of normal (ULN) occurred in 4.8% of patients.

The most common adverse reactions (≥30%) of any grade in patients with CLL were anemia,* neutropenia,* thrombocytopenia,* headache, upper respiratory tract infection, and diarrhea.

*Treatment-emergent decreases (all grades) of hemoglobin, platelets, and neutrophils were based on laboratory measurements and adverse reactions.

In patients with previously untreated CLL exposed to CALQUENCE, fatal adverse reactions that occurred in the absence of disease progression and with onset within 30 days of the last study treatment were reported in 2% for each treatment arm, most often from infection. Serious adverse reactions were reported in 39% of patients in the CALQUENCE plus obinutuzumab arm and 32% in the CALQUENCE monotherapy arm, most often due to events of pneumonia (7% and 2.8%, respectively).

Adverse reactions led to CALQUENCE dose reduction in 7% and 4% of patients in the CALQUENCE plus obinutuzumab arm (N=178) and CALQUENCE monotherapy arm (N=179), respectively. Adverse events led to discontinuation in 11% and 10% of patients, respectively. Increases in creatinine to 1.5 to 3 times ULN occurred in 3.9% and 2.8% of patients in the CALQUENCE combination arm and monotherapy arm, respectively.

In patients with relapsed/refractory CLL exposed to CALQUENCE, serious adverse reactions occurred in 29% of patients. Serious adverse reactions in >5% of patients who received CALQUENCE included lower respiratory tract infection (6%). Fatal adverse reactions within 30 days of the last dose of CALQUENCE occurred in 2.6% of patients, including from second primary malignancies and infection.

Adverse reactions led to CALQUENCE dose reduction in 3.9% of patients (N=154), dose interruptions in 34% of patients, most often due to respiratory tract infections followed by neutropenia, and discontinuation in 10% of patients, most frequently due to second primary malignancies followed by infection. Increases in creatinine to 1.5 to 3 times ULN occurred in 1.3% of patients who received CALQUENCE.

DRUG INTERACTIONS

Strong CYP3A Inhibitors: Avoid co-administration of CALQUENCE with a strong CYP3A inhibitor. If these inhibitors will be used short-term, interrupt CALQUENCE. After discontinuation of strong CYP3A inhibitor for at least 24 hours, resume previous dosage of CALQUENCE.

Moderate CYP3A Inhibitors: Reduce the dosage of CALQUENCE to 100 mg once daily when co-administered with a moderate CYP3A inhibitor.

Strong CYP3A Inducers: Avoid co-administration of CALQUENCE with a strong CYP3A inducer. If co-administration is unavoidable, increase the dosage of CALQUENCE to 200 mg approximately every 12 hours.

SPECIFIC POPULATIONS

Based on findings in animals, CALQUENCE may cause fetal harm and dystocia when administered to a pregnant woman. There are no available data in pregnant women to inform the drug-associated risk. Advise pregnant women of the potential risk to a fetus.

Pregnancy testing is recommended for females of reproductive potential prior to initiating CALQUENCE therapy.

Contacts

Media Inquiries

Brendan McEvoy

+1 302 885 2677

Miranda Kulp

+1 302 885 2677

US Media Mailbox: usmediateam@astrazeneca.com

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