Business Wire

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

Jaa

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

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Smart Link Accelerates Digital Service Expansion with Avaya Cloud Contact Center Solutions17.10.2018 15:37Tiedote

Smart Link, a subsidiary of Al Khaleej for Training and Education and a leading Saudi-based Business Process Outsourcing (BPO) company, has teamed up with Avaya Holdings Corp. (NYSE:AVYA) to accelerate Smart Link’s expansion and the diversification of its digital services portfolio. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181017005478/en/ Avaya signs a Memorandum of Understanding with Smart Link during GITEX Technology Week 2018 (Photo: Business Wire) The two companies signed a Memorandum of Understanding (MoU) during GITEX Technology Week with a focus on digital and cloud-based solutions that will enable Smart Link to have greater agility and flexibility in meeting its customers’ demands for digital services. In alignment with Saudi Vision 2030, Smart Link is digitalizing and automating all possible duties to increase its human value while delivering cutting-edge communication solutions to connect government and priv

Visa Unveils New Partners on Tokenization to Help Increase Payment Security and Reduce Effects of Data Breaches17.10.2018 15:00Tiedote

Visa Inc. (NYSE:V) today announced the commercial expansion of the Visa Token Service for credential-on-file (COF) token requestors, marking a major milestone towards further securing consumer payments in the digital channel. With this expansion, acquirer gateway and technology partners Adyen, AsiaPay, Braintree, Checkout.com, Cherri Tech, CyberSource, Elavon, Ezidebit, eWAY, Fit-Pay, Giesecke & Devrient, PayPal, Payscout, Rambus, SafeCharge, SecureCo, Square, Stripe, Worldpay and YellowPepper are or will soon be able to tokenize credential-on-file digital payments on behalf of their merchant and payment clients. Built on top of the EMVCo Payment Tokenization Standard, the Visa Token Service offers another layer of security by replacing sensitive cardholder information, such as personal account numbers and expiration dates, with a unique digital identifier (a “token”) that can be used for payment without exposing a cardholder’s more sensitive account information. In addition to enhanci

Moody’s Names Derek Vadala as Global Head of Cyber Risk for MIS17.10.2018 14:00Tiedote

Moody’s Corporation (NYSE:MCO) today announced that it has named Derek Vadala as Global Head of Cyber Risk for Moody’s Investors Service (MIS). In this newly-established role, Mr. Vadala will develop MIS’s capabilities for evaluating cyber risk, including a framework for the consideration of cybersecurity risk in credit analysis, and will spearhead innovative research, analytics and market outreach in this area. “As with environmental, social and governance risks, we see cyber risk as an area of increasing relevance to issuers, investors, counterparties and government authorities as it impacts operational and credit risk. Moody’s has a unique perspective that can help enhance market understanding of the ways credit and cyber risk intersect,” said Rob Fauber, President of Moody’s Investors Service. “Derek has a wealth of direct leadership experience in cyber and information security, and we are fortunate to have him lead the development of our cyber risk analysis capabilities.” Mr. Vada

Nadia Murad to Speak at Sharjah Conference Aimed at Boosting Opportunities for MENA’s Youth17.10.2018 13:29Tiedote

In the run up to one of MENA region’s premier conferences dedicated to addressing development challenges and humanitarian issues, the third edition of ‘Investing in the Future’ Conference (IIFMENA) slated for October 24-25 in Sharjah, UAE, will be seeing participation of Iraqi Human rights activist and 2018 Nobel peace prize winner, Nadia Murad. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181017005371/en/ Nadia Murad (Archive) With key partners UNHCR, UNICEF, UNDP and NAMA-UN Women, IIFMENA 2018 will shed the spotlight on ways governments, civil society, international organisations, academia, private sector can collaborate to involve the region’s youth more effectively in consultative, policy- and decision-making processes, enabling a more inclusive and participatory approach to tackling challenges and offering practical, scalable solutions. It is the first time since the 25-year-old Iraqi human rights activist has receiv

Bentley Systems Releases Open-Source Library: iModel.js17.10.2018 11:58Tiedote

Bentley Systems, Incorporated, the leading global provider of comprehensive software solutions for advancing the design, construction, and operations of infrastructure, today announced the initial release of its iModel.js library, an open-source initiative to improve the accessibility, for both visualization and analytical visibility, of infrastructure digital twins. iModel.js can be used by developers and IT professionals to quickly and easily create immersive applications that connect their infrastructure digital twins with the rest of their digital world. iModel.js is the cornerstone of Bentley’s just-announced iTwin™ Services that combine iModelHub, reality modeling, and web-enabling software technologies within a Connected Data Environment (CDE) for infrastructure engineering. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181017005008/en/ Bentley Systems Releases Open-Source Library: iModel.js.(Photo: Business Wire) Be

WHOOP, the Human Performance Company, Launches in Europe17.10.2018 10:00Tiedote

WHOOP, the human performance company, is now available to European consumers for the first time. Launched in the US in 2014, WHOOP is now shipping to countries throughout Europe via the WHOOP website. Initial countries include Belgium, Denmark, Finland, France, Germany, Ireland, Italy, the Netherlands, Spain, Sweden and the United Kingdom. Many pro athletes and teams across Europe are already using WHOOP, which was first made available to consumers in the US in 2016. WHOOP was co-founded in 2012 by former Harvard students Will Ahmed, John Capodilupo and Aurelian Nicolae. As captain of Harvard’s D1 squash team, Ahmed, the company's CEO, found that he and his teammates frequently over trained, misinterpreted fitness peaks, and underestimated recovery and sleep, often leading to injury. He became inspired by a simple idea: Humans, especially athletes, could optimize their daily performance if they had a systematic approach to understanding their bodies. The WHOOP Strap 2.0 is a wearable d

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme