AstraZeneca’s Calquence (acalabrutinib) Demonstrates Activity in Relapsed or Refractory Mantle Cell Lymphoma Trial
AstraZeneca and Acerta Pharma, its haematology research and development centre of excellence, today presented results from the open-label, single-arm Phase II ACE-LY-004 clinical trial, which served as the basis for the recent US Food and Drug Administration (FDA) accelerated approval of Calquence (acalabrutinib). The findings were presented for the first time during an oral session at the 59th American Society of Hematology (ASH) Annual Meeting & Exhibition in Atlanta, USA and demonstrate the safety profile and efficacy of acalabrutinib in the management of previously-treated mantle cell lymphoma (MCL).
Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “The results presented for the first time to the medical community highlight the potential of Calquence as a treatment for people with relapsed or refractory mantle cell lymphoma, a life-threatening form of blood cancer. These data reinforce the important progress of our clinical development programme as well as our commitment to advancing the treatment of patients with blood cancers.”
Michael L. Wang, MD, Professor, Department of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center, and Principal Investigator of the ACE-LY-004 MCL clinical trial, said: “Most people living with mantle cell lymphoma will unfortunately relapse, and new treatment options are greatly needed. As shown by the consistent overall response rates observed in this trial across several pre-specified subgroups, acalabrutinib is a welcome new treatment option for certain patients with this aggressive blood cancer.”
Summary of key investigator-assessed efficacy results from ACE-LY-004 (15.2 months median follow-up):
|Efficacy measure||Patients (percent response)|
Overall response rate
81% (95% CI: 73,87)
40% (95% CI: 31,49)
41% (95% CI: 32,50)
|Stable disease||9% (95% CI: 5,15)|
|Progressive disease||8% (95% CI: 4,14)|
|Not evaluable||2% (95% CI: 1,7)|
Per the 2014 Lugano classification response criteria for non-Hodgkin lymphoma; high concordance was observed between investigator-assessed and independent review committee-assessed overall response and complete response rates, respectively.
The overall response rate was consistent across multiple subgroups including age, tumour burden and number or type of prior treatments. The secondary endpoint of median duration of response had not yet been reached at 15.2 months median follow-up. The median time-to-response, an exploratory endpoint, was 1.9 months. After 12 months of treatment, 72% (95% CI: 62,80) of patients were still responding to acalabrutinib treatment. The secondary endpoints of progression-free survival and overall survival had not yet been reached; at 12 months, the progression-free survival and overall survival rates were 67% (95% CI: 58,75) and 87% (95% CI: 79,92), respectively.
In this trial, the most common non-haematological adverse reactions (reported in ≥20% of patients at a median follow-up time of 15.2 months) were headache (38%), diarrhoea (30%), fatigue (26%) and myalgia (21%), per investigator assessment. Grade 3 or 4 adverse reactions (≥5%) included anaemia (12%), neutropenia (11%), and pneumonia (6%).
Calquence was granted accelerated approval by the US FDA in October 2017 for the treatment of adult patients with MCL who have received at least one prior therapy. This indication is approved based on overall response rate, and continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
– ENDS –
NOTES TO EDITORS
About Calquence (acalabrutinib)
Acalabrutinib (previously known as ACP-196) is a selective inhibitor of 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.2,3,4 In B cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis and adhesion.2
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 also in development for the treatment of multiple B-cell malignancies and other blood cancers including 1st-line MCL, chronic lymphocytic leukaemia (CLL), Waldenström macroglobulinaemia (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.5
Acalabrutinib was granted Orphan Drug Designation by the European Commission in March 2016 and 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 Mantle Cell Lymphoma (MCL)
MCL is an aggressive B-cell non-Hodgkin lymphoma (NHL) with poor prognosis.6,7,8,9 MCL accounts for approximately 3% to 6% of new NHL cases in Western countries each year; in the US, approximately 3,300 new cases of MCL are diagnosed each year.6,10 The median age at diagnosis is 68 years, with a 3:1 male predominance.7 While MCL patients initially respond to treatment, there is a high relapse rate.6
About the ACE-LY-004 Trial
ACE-LY-004 is a Phase II open-label, single-arm clinical trial in 124 adult patients with relapsed or refractory MCL. The trial showed that 81% (95% CI: 73,87) of patients treated with acalabrutinib achieved an overall response; 40% (95% CI: 31,49) achieved a complete response and 41% (95% CI: 32,50) achieved a partial response, per 2014 Lugano classification as assessed by investigator.1
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.
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.
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-23706. AstraZeneca Pharmaceuticals
LP, Wilmington, DE.
Karen Birmingham: +44 781 852 4012
Mike Hayes: +1 301-398-0221
Hugues Joublin: +1 301-398-3041
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 15:37 | Tiedote
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 15:00 | Tiedote
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 14:00 | Tiedote
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 13:29 | Tiedote
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 11:58 | Tiedote
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 10:00 | Tiedote
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