AstraZeneca demonstrates strengths in haematology with robust data at ASH 2020

Presentations support Calquence efficacy and tolerability with long-term follow-up
in mantle cell lymphoma and pooled safety data in chronic lymphocytic leukaemia

Emerging pipeline shows promise with novel targets and
mechanisms to treat resistant and aggressive blood cancers

AstraZeneca will present new research aimed at addressing key unmet needs facing patients with blood cancers at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, held virtually from 5 to 8 December 2020.

The Company will present 27 abstracts spanning five medicines and potential new medicines and eight different haematology conditions that demonstrate the Company’s commitment to advancing haematology research and treatments for patients living with haematologic malignancies.

Key data presentations include:

• A pooled analysis of data from four trials - ELEVATE TN, ASCEND, ACE-CL-001 and 15-H-0016 - expanding on the cardiovascular safety profile of Calquence monotherapy treatment for patients with chronic lymphocytic leukaemia (CLL)

• Extended follow-up data from the pivotal Phase II ACE-LY-004 trial that support long-term treatment with Calquence in adult patients with relapsed or refractory mantle cell lymphoma (MCL)

• Data on Calquence in combination with venetoclax and either obinutuzumab or rituximab in patients with CLL, showing a safety profile consistent with previous trials with high complete responses and undetectable minimal residual disease rates after a median follow-up of 26.9 months, with minimal to no drug-drug interactions in the Phase Ib ACE-CL-003 trial

• First-in-human data from the potential new medicine B-cell maturation antigen (BCMA)-targeted antibody drug conjugate, MEDI2228, presenting data on safety and efficacy at all dose levels in relapsed or refractory multiple myeloma

• Data showing pre-clinical evidence of overcoming resistance in relapsed or refractory MCL from the dual BCL2/XL inhibitor, AZD4320, which blocks the anti-apoptotic effect of BCL2 and BCLXL

• Phase I data from the anti-inducible co-stimulator anti-ICOS monoclonal antibody, MEDI-570, demonstrating promising early clinical activity in poor-risk refractory and heavily pre-treated patients with angioimmunoblastic T-cell lymphoma

• Multiple studies on roxadustat, the first in a new class of medicines evaluating its clinical effectiveness and safety profile in both the dialysis dependent and non-dialysis dependent anaemia of CKD patient populations

• Data on roxadustat assessing efficacy in anaemia secondary to lower-risk myelodysplastic syndrome (MDS) regardless of baseline factors. In approximately one in three patients MDS leads to acute myeloid leukaemia.¹

Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: “Our data at ASH this year continue to support Calquence as a well-tolerated treatment with impressive efficacy and safety across multiple blood cancers, reinforcing physicians’ confidence in treating patients with Calquence over the long term. Data at the meeting will also explore Calquence combinations with commonly used therapies, showing potential across a variety of regimens in chronic lymphocytic leukaemia to best suit the unique needs of each patient.”

José Baselga, Executive Vice President, Oncology R&D, said: “As we rapidly expand our presence in haematology, we are focused on identifying novel targets and mechanisms of action that can address the most urgent unmet needs across various haematological malignancies. Our early portfolio at this year’s ASH clearly demonstrates our commitment to following the science in combating treatment-resistant and rare blood cancers.”

Key AstraZeneca presentations during the 62nd ASH Annual Meeting and Exposition

Calquence

Calquence (acalabrutinib) is a next-generation, selective inhibitor of Bruton’s tyrosine kinase (BTK). Calquence binds covalently to BTK, thereby inhibiting its activity.^2,3 In B-cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion.²

As part of an extensive clinical development programme, AstraZeneca and Acerta Pharma are currently evaluating Calquence in more than 20 company-sponsored clinical trials. Calquence is being developed for the treatment of multiple B-cell blood cancers including CLL, MCL, diffuse large B-cell lymphoma, Waldenström macroglobulinaemia, follicular lymphoma, and other haematologic malignancies.

Roxadustat

Roxadustat is a first-in-class oral small molecule hypoxia-inducible-factor prolyl hydroxylase inhibitor (HIF-PHI) that promotes erythropoiesis through increased endogenous production of erythropoietin; improved iron absorption, transport and mobilisation; and downregulation of hepcidin, which helps to overcome the negative impact of inflammation on haemoglobin synthesis and red blood cell production. Roxadustat is approved in China for the treatment of anaemia in adult patients with CKD, both on dialysis and not on dialysis. In Japan, roxadustat is approved for the treatment of anaemia in CKD patients on dialysis, and a supplemental New Drug Application (NDA) for the treatment of anaemia in CKD patients not on dialysis is under regulatory review. The roxadustat NDA for the treatment of anaemia in CKD in both NDD and DD is under review by the US Food and Drug Administration with a decision expected in Q4 2020. The Marketing Authorisation Application for roxadustat for the treatment of anaemia in CKD in both NDD and DD was filed by Astellas and accepted by the European Medicines Agency for review on 21 May 2020. Roxadustat is also in clinical development for anaemia associated with MDS and for chemotherapy-induced anaemia.

AstraZeneca and FibroGen Inc. (FibroGen) are collaborating on the development and commercialisation of roxadustat for the potential treatment of anaemia in the US, China and other markets in the Americas and in Australia/New Zealand, as well as Southeast Asia. Astellas and FibroGen are collaborating on the development and commercialisation of roxadustat for the potential treatment of anaemia in territories including Japan, Europe, the Commonwealth of Independent States, the Middle East and South Africa.

AstraZeneca in haematology

Leveraging its strength in oncology, AstraZeneca has established haematology as one of four key oncology disease areas of focus. The Company’s haematology franchise includes two medicines approved by the US Food and Drug Administration and a robust global development programme for a broad portfolio of potential blood cancer treatments. Acerta Pharma serves as AstraZeneca’s haematology research and development arm. AstraZeneca partners with like-minded science-led companies to advance the discovery and development of therapies to address unmet need.

AstraZeneca in oncology

AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients' lives and the Company's future. With seven new medicines launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers.

By harnessing the power of six scientific platforms - Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response, Antibody Drug Conjugates, Epigenetics, and Cell Therapies - 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.

AstraZeneca

AstraZeneca (LSE/STO/Nasdaq: AZN) 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, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.

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References

1. American Cancer Society. What Are Myelodysplastic Syndromes? Available online. Accessed October 2020.

2. Calquence (acalabrutinib) [prescribing information]. Wilmington, DE; AstraZeneca Pharmaceuticals LP; 2019.

3. Wu J, Zhang M & Liu D. Acalabrutinib (ACP-196): a selective second-generation BTK inhibitor. J Hematol Oncol. 2016;9(21).