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AstraZeneca’s Calquence (acalabrutinib) Shows Potential in Chronic Lymphocytic Leukaemia Trials

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AstraZeneca and Acerta Pharma, its haematology research and development centre of excellence, today presented results from the Phase Ib/II ACE-CL-003 clinical trial (Abstract #432) and updated results from the Phase I/II ACE-CL-001 (Abstract #498) clinical trial that are testing Calquence (acalabrutinib) alone and in combination for the treatment of chronic lymphocytic leukaemia (CLL) in multiple treatment settings. The findings were presented during two oral sessions at the 59th American Society of Hematology (ASH) Annual Meeting & Exhibition in Atlanta, USA.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “These data add to the growing body of evidence that supports the potential of Calquence in the treatment of chronic lymphocytic leukaemia, a life-threatening disease that affects tens of thousands of people around the world. These emerging clinical data underscore AstraZeneca’s commitment to advancing the science of blood cancer treatments.”

Jennifer Woyach, MD, Associate Professor of Internal Medicine, Division of Hematology, The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, said: “Despite treatment advances for chronic lymphocytic leukaemia in recent years, the urgent need for additional treatment options remains. The overall response rates observed in the acalabrutinib trials and presented at ASH highlight the potential impact that this investigational treatment could have on the management of CLL.”

New, early acalabrutinib data from ACE-CL-003 combination therapy trial
Data on two patient cohorts treated with acalabrutinib and obinutuzumab from the Phase Ib/II ACE-CL-003 trial were presented. The primary endpoint of overall response rate was 95% (95% CI: 74,100) for the 19 patients in the treatment-naïve cohort and 92% (95% CI: 75,99) in the 26 patients with relapsed or refractory CLL. Additionally, the complete response rate was 16% for treatment-naïve patients and 8% for previously-treated patients. At approximately 2 years median study follow-up, the secondary endpoints of duration of response and median progression-free survival had not yet been reached in either patient cohort.

Across both cohorts in the trial, the most common adverse reactions (≥25%) of any grade were upper respiratory tract infection (69%), maculopapular rash (64%), increased weight (64%), diarrhoea (62%), cough (58%), nausea (51%), headache (47%), infusion-related reaction (42%), contusion (42%), dizziness (42%), arthralgia (40%), vomiting (40%), constipation (38%), hypertension (38%), skin lesion (38%), fatigue (36%), peripheral oedema (36%), decreased appetite (33%), sinusitis (33%), fall (31%), myalgia (31%), oral pain (31%), dyspepsia (27%) and paraesthesia (27%). One patient with relapsed or refractory CLL who had a history of atrial fibrillation experienced intermittent atrial fibrillation (Grade 3), which was not considered treatment related and did not lead to treatment discontinuation.

Updated acalabrutinib monotherapy efficacy and safety from ACE-CL-001 trial
In a separate oral session, investigators presented new longer-term follow-up safety (primary endpoint) and efficacy (secondary endpoint) data testing acalabrutinib as a monotherapy in the full-study cohort of 134 patients with relapsed or refractory CLL at median time on study and follow-up of 24.5 months. These data expand on earlier findings previously reported in 61 patients at median time on study and follow-up of 14.3 months.

These latest findings from the trial highlight the overall response rate and duration of response in this patient population. With a median time on study and follow-up of 24.5 months, overall response was 87% (95% CI: 80,92) and the overall response including partial response with lymphocytosis (increase in number of lymphocytes in the blood) was 93% (95% CI: 88,97); median duration of response was not reached. The complete response was 4% (3 patients). The median progression-free survival, a secondary endpoint in the trial, was not yet reached; however, based on the Kaplan-Meier estimate, the progression-free survival rate at 18 months was 90% (95% CI: 83,94).

In this trial, the most common adverse reactions (≥20%) of any grade were diarrhoea (48%), headache (47%), upper respiratory tract infection (31%), fatigue (28%), nausea (26%), cough (24%), arthralgia (25%), pyrexia (23%), contusion (23%), weight increased (21%), petechiae (21%) and constipation (20%). Grade ≥3 adverse reactions (≥5% of patients) were neutropoenia (12%) and pneumonia (11%). 22% of patients discontinued treatment.

The Phase I/II CLL clinical trial (ACE-CL-003 and ACE-CL-001) findings are part of an extensive development programme for acalabrutinib in a range of blood cancers, which includes three ongoing Phase III clinical trials (ACE-CL-006, ACE-CL-007 and ACE-CL-309) in patients with CLL.

– ENDS –

NOTES TO EDITORS

About Calquence (acalabrutinib)
Acalabrutinib (previously known as ACP-196) is a selective inhibitor of Bruton tyrosine kinase (BTK). Acalabrutinib binds covalently to BTK, thereby inhibiting its activity, and has demonstrated this with minimal interactions with other immune cells in pre-clinical studies.3,4,5,6 In B cells, BTK signalling results in activation of pathways necessary for B cell proliferation, trafficking, chemotaxis, and adhesion.3

Calquence was granted accelerated approval by the US Food and Drug Administration (FDA) in October 2017 for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Acalabrutinib is not approved for use outside of its labelled indication in the US and is not approved in any other country at this time.

Acalabrutinib is in development for the treatment of multiple B-cell malignancies and other cancers including CLL, MCL, Waldenström macroglobulinaemia, follicular lymphoma, diffuse large B-cell lymphoma, and multiple myeloma. It is also being studied as a monotherapy and in combination trials for the treatment of solid tumours. More than 35 clinical trials across 40 countries with more than 2,500 patients are underway or have completed.7

Acalabrutinib was granted Orphan Drug Designation by the European Commission in March 2016 and by the US FDA in 2015 for the treatment of patients with CLL, MCL and WM, and Breakthrough Therapy Designation in August 2017 by the US FDA for the treatment of patients with MCL who have received at least one prior therapy.

About Chronic Lymphocytic Leukaemia
Chronic lymphocytic leukaemia (CLL) is the most common type of leukaemia in adults and accounts for approximately one in four cases of leukaemia.8,9 The average age at the time of diagnosis is approximately 71 years of age.9 In CLL, too many blood stem cells in the bone marrow become abnormal lymphocytes and these abnormal cells have difficulty fighting infections.8 As the number of abnormal cells grows there is less room for healthy white blood cells, red blood cells and platelets.8 This could result in anaemia, infection and uncontrolled bleeding.8 B cell receptor signalling through BTK is one of the essential growth pathways for CLL.

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 aimed 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 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.

Intended audiences
This press release is issued from AstraZeneca Corporate Headquarters in Cambridge, UK and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where AstraZeneca conducts business.

___________________________

1 Data on File. REF-23705. AstraZeneca Pharmaceuticals LP, Wilmington, DE.
2 Data on File. REF-23704. AstraZeneca Pharmaceuticals LP, Wilmington, DE.
3 Data on File. REF-23706. AstraZeneca Pharmaceuticals LP, Wilmington, DE.
4 Calquence (acalabrutinib) Prescribing Information. AstraZeneca Pharmaceuticals LP, Wilmington, DE
5 Covey T, Barf T, Gulrajani M, Krantz F, van Lith B, Bibikova E, et al. Abstract 2596: ACP-196: a novel covalent Bruton’s tyrosine kinase (Btk) inhibitor with improved selectivity and in vivo target coverage in chronic lymphocytic leukemia (CLL) patients. Cancer Res. 2015;75(15 Supplement):2596.
6 Harrington BK, Gulrajani M, Covey T, Kaptein A, Van Lith B, Izumi R, et al. ACP-196 is a second generation inhibitor of Bruton tyrosine kinase (BTK) with enhanced target specificity. Blood. 2015;126(23):2908.
7 Data on File. REF US-15441. AstraZeneca Pharmaceuticals LP, Wilmington, DE.
8 National Cancer Institute. Chronic Lymphocytic Leukemia Treatment (PDQ®)–Patient Version. https://www.cancer.gov/types/leukemia/patient/cll-treatment-pdq. Accessed December 2017.
9 American Cancer Society. What are the key statistics for chronic lymphocytic leukemia? http://www.cancer.org/cancer/leukemia-chroniclymphocyticcll/detailedguide/leukemia-chronic-lymphocytic-key-statistics. Accessed December 2017.

Contact information

AstraZeneca
Karen Birmingham, +44 781 852 4012
Mike Hayes, +1 301-398-0221
Hugues Joublin, +1 301-398-3041

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