On December 6, 2017 AstraZeneca, along with Acerta Pharma, its haematology research and development centre of excellence, and MedImmune, its global biologics research and development arm, will highlight significant progress in blood cancer research at the 59th 2017 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exhibition in Atlanta, USA (Press release, AstraZeneca, DEC 6, 2017, View Source [SID1234522396]). Presentations will include new data from AstraZeneca’s emerging haematology portfolio in several cancer types including mantle cell lymphoma (MCL), chronic lymphocytic leukaemia (CLL), hairy cell leukaemia (HCL), acute myeloid leukaemia (AML), multiple myeloma and diffuse large B-cell lymphoma (DLBCL).
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Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: "Following the recent accelerated approval of AstraZeneca’s first medicine for a blood cancer, Calquence, we will share a broad range of new data at ASH (Free ASH Whitepaper) highlighting our scientific progress in haematology as we seek to develop potential medicines that advance patient care."
Efficacy and safety of Calquence in the management of previously-treated MCL
Following the US Food and Drug Administration (FDA) accelerated approval of Calquence (acalabrutinib), a kinase inhibitor indicated for the treatment of adult patients with MCL who have received at least one prior therapy, data from the pivotal Phase II ACE-LY-004 clinical trial on which the accelerated approval was based, will be presented for the first time (Abstract #155). New details of the trial will be shared, including median time to response, pre-specified patient subgroup efficacy analyses, as well as safety analyses, further characterising the clinical profile of Calquence in this patient population.
Calquence as monotherapy and in combination in multiple CLL patient populations
Results will be presented from the Phase Ib/II ACE-CL-003 trial evaluating Calquence and obinutuzumab in treatment-naïve and previously-treated CLL patients (Abstract #432), which highlight the safety profile and activity of the combination. Long-term follow-up safety and efficacy data from the Phase I/II ACE-CL-001 clinical trial which tested Calquence as a monotherapy in a large cohort of patients with relapsed or refractory CLL (Abstract #498) will expand on findings previously reported; these data will highlight the favourable duration of response in this patient population.
Early-stage haematology portfolio
AstraZeneca will present additional data from its haematology portfolio, including findings from a Phase I trial of moxetumomab pasudotox, an anti-CD22 recombinant immunotoxin and potential new medicine in development for the treatment of people with previously-treated HCL (Abstract: #2765)
Early data on AZD2811, a novel nanoparticle inhibitor of aurora kinase B being tested in AML (Abstract #1368)
Preclinical data from trials on MEDI2228, a BCMA-targeting pyrrolobenzodiazepine-linked antibody drug conjugate being tested in multiple myeloma (Abstract #3153)
Data from a trial of vistusertib (AZD2014), a dual mTORC1/2 inhibitor being tested in DLBCL (Abstract #4113).
NOTES TO EDITORS
A full list of company-sponsored abstracts to be presented at ASH (Free ASH Whitepaper) are as follows:
Abstract Number
Title
Presentation Details
Abstract #155
Efficacy and safety of acalabrutinib monotherapy in patients with relapsed/refractory mantle cell lymphoma in the Phase II ACE-LY-004 study
Oral session, Saturday, December 9, 1 p.m. EST
Location: Georgia World Congress Center, Building A, Level 4, A411-A412
Abstract #1741
Pharmacodynamic evaluation of acalabrutinib in relapsed/refractory and treatment-naive patients with chronic lymphocytic leukemia in the Phase I/II ACE-CL-001 study
Poster sessions, Saturday, December 9, 5:30-7:30 p.m. EST
Location: Georgia World Congress Center, Building A, Level 1, Hall A2
Abstract #1268
Exposure-response of the Bruton tyrosine kinase inhibitor, acalabrutinib in the treatment of hematologic malignancies
Abstract: #1243
Concurrent treatment with Pim kinase inhibitor downregulates alternative non-homologous end-joining repair and decreases genomic instability in FLT3-ITD cells treated with topoisomerase 2 inhibitors
Abstract #1368
Preclinical and early Phase I clinical data of AZD2811 nanoparticle in AML, an aurora B kinase inhibitor
Abstract #432
Acalabrutinib with obinutuzumab in relapsed/refractory and treatment-naive patients with chronic lymphocytic leukemia: The Phase Ib/II ACE-CL-003 study
Oral session, Sunday, December 10, 1:15 p.m. EST
Location: Georgia World Congress Center, Building B, Level 5, Murphy BR 3-4
Abstract #498
Acalabrutinib monotherapy in patients with relapsed/refractory chronic lymphocytic leukemia: Updated results from the Phase I/II ACE-CL-001 study
Oral session, Sunday, December 10, 5:45 p.m. EST
Location: Georgia World Congress Center, Building B, Level 5, Murphy BR 3-4
Abstract: #2765
Negative minimal residual disease associated with extended response to moxetumomab pasudotox in patients with relapsed/refractory hairy cell leukemia: Long-term follow-up of bone marrow immunohistochemistry analyses from a Phase I study
Poster Session, Sunday, December 10, 6-8 p.m. EST
Location: Georgia World Congress Center, Building A, Level 1, Hall A2
Abstract: #3153
Preclinical evaluation of MEDI2228, a BCMA-targeting pyrrolobenzodiazepine-linked antibody drug conjugate for the treatment of multiple myeloma
Abstract #3442
Adverse events, resource use, and economic burden in patients with mantle cell lymphoma in the United States
Abstract #4326
Pooled analysis of safety data from clinical trials evaluating acalabrutinib monotherapy in hematologic malignancies
Poster sessions, Monday, December 11, 6-8 p.m. EST
Location: Georgia World Congress Center, Building A, Level 1, Hall A2
Abstract #4060
Understanding ibrutinib treatment discontinuation patterns for chronic lymphocytic leukaemia
Abstract #4684
MCL treatment patterns and outcomes: A community oncology practice experience
Abstract #4113
Combined inhibition of mTOR and BTK signaling is required for optimal long-term growth inhibition in DLBCL models
About Calquence
Calquence (acalabrutinib; previously known as ACP-196) is a selective inhibitor of BTK. Calquence binds covalently to BTK, irreversibly inhibiting its activity, and has demonstrated this with minimal interactions with other immune cells in pre-clinical studies.5 In B cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis and adhesion.1
The recommended dose of Calquence is one 100mg capsule taken orally approximately every twelve hours until disease progression or unacceptable toxicity.1 Calquence may be taken with or without food.1
Calquence is also in development for the treatment of multiple B-cell malignancies and other cancers including 1st-line MCL, chronic lymphocytic leukaemia (CLL), Waldenström macroglobulinemia (WM), follicular lymphoma, diffuse large B-cell lymphoma, and multiple myeloma. It is also being developed as a monotherapy and in combination trials for solid tumours. More than 35 clinical trials across 40 countries with more than 2,500 patients are underway or have been completed.
Calquence was granted Orphan Drug Designation by the US FDA for the treatment of adult patients with MCL in September 2015 and by the European Commission in March 2016 for the treatment of adult patients with CLL, MCL and WM.
About AstraZeneca in Oncology
AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly-growing portfolio of new medicines that have the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020 and a broad pipeline of small molecules and biologics in development, we are committed to advance New Oncology as one of AstraZeneca’s five Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy as illustrated by our investment in Acerta Pharma in haematology.
By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.