AstraZeneca to highlight its commitment to blood cancers at the 2017 American Society of Hematology Annual Meeting

First data presentation of Calquence, recently approved in the US for patients with previously-treated mantle cell lymphoma

New data on five potential new medicines in development across six types of blood cancer

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) Annual Meeting & Exhibition in Atlanta, USA. 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).

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 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 are as follows:

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.

About Acerta Pharma

Acerta Pharma, a member of the AstraZeneca Group, is creating novel therapies intended for the treatment of cancer and autoimmune diseases. AstraZeneca acquired a majority stake interest in Acerta Pharma, which serves as AstraZeneca’s haematology research and development centre of excellence. For more information, please visit www.acerta-pharma.com.

About MedImmune

MedImmune is the global biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of small molecule and biologic prescription medicines. MedImmune is pioneering innovative research and exploring novel pathways across Oncology; Respiratory, Cardiovascular & Metabolic Diseases; and Infection and Vaccines. The MedImmune headquarters is located in Gaithersburg, Md., one of AstraZeneca’s three global R&D centres, with additional sites in Cambridge, UK, and Mountain View, CA. For more information, please visit www.medimmune.com.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

For more information, please visit www.astrazeneca.com and follow us on Twitter @AstraZeneca.

CONTACTS

References

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2. US Food and Drug Administration. Guidance for Industry Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM390058.pdf. Accessed August 2017.

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6. Leukemia & Lymphoma Society. Mantle Cell Lymphoma Facts. https://www.lls.org/sites/default/files/file_assets/mantlecelllymphoma.pdf. Accessed June 2017

7. Cheah CY, Seymour JF, Wang M. Mantle Cell Lymphoma. Journal of Clinical Oncology 34, no. 11 (April 2016) 1256-1269.

8. Hoster E, Klapper W et al. Confirmation of the Mantle-Cell Lymphoma International Prognostic Index in Randomized Trials of the European Mantle-Cell Lymphoma Network. Journal of Clinical Oncology 2014;32:1338-1346.

9. Dreyling M, Ferrero S. The role of targeted treatment in mantle cell lymphoma: Is transplant dead or alive? Haematologica 2016 Volume 101(2):104-114

10. Teras LR, DeSantis CE, Cerhan JR, et al. 2016 US lymphoid malignancy statistics by World Health Organization subtypes. CA Cancer J Clin. 2016;66:443-459.