Calquence shows durable efficacy and favourable tolerability vs. standards of care across multiple analyses in chronic lymphocytic leukaemia
New Calquence tablet formulation will potentially expand eligible patient population with comparable efficacy and safety to current capsules
Emerging pipeline will also demonstrate promise of inducing deeper patient responses using novel combinations for hard-to-treat blood cancers
AstraZeneca will present new data underscoring its commitment to transforming haematologic cancer care at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition, 11 to 14 December 2021.
More than 25 abstracts will feature data across the Company's haematology portfolio and pipeline, including new analyses from the Calquence (acalabrutinib) Phase III programme such as an oral presentation of three-year follow-up data from the ASCEND Phase III trial in relapsed or refractory chronic lymphocytic leukaemia (CLL).
Overall, data will span over 10 types of blood cancers and related conditions with a focus on CLL, mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL) and acute myeloid leukaemia.
Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: "Our robust Calquence data at ASH will include an important new formulation designed to expand the pool of patients who may benefit from Calquence. Moreover, data from three Phase III trials will show the sustained efficacy and safety of Calquence, which is central to our commitment to prioritise the patient experience while providing long-term control of the disease in those with chronic lymphocytic leukaemia."
Anas Younes, Senior Vice President, Haematology R&D, AstraZeneca, said: "Testing new ways of overcoming drug resistance and continually pushing for better and deeper responses for patients are core focus areas of our early haematology portfolio. The preclinical data we are presenting at this year's ASH meeting for capivasertib and AZD4573 add to the emerging body of evidence showing the potential for new approaches to become the cornerstones of tomorrow's combination therapies for hard-to-treat blood cancers."
- A risk-benefit analysis showing quality-adjusted time without symptoms or toxicity (Q-TWiST) from the ELEVATE-RR and ASCEND trials in relapsed or refractory CLL will report the difference between Calquence and either ibrutinib or the combination of rituximab with idelalisib or bendamustine, balancing risk (toxicity) and benefit (prolonged survival without symptoms of progression or adverse events)
- Data introducing a maleate tablet formulation of Calquence will establish bioequivalence to the current capsule and would enable co-administration with proton pump inhibitors or via nasogastric tube for patients with swallowing challenges, offering an opportunity to provide Calquence to patients for whom it was previously not an option
- An oral presentation will show durable efficacy for Calquence over three years in relapsed or refractory CLL from the ASCEND trial, evaluating the treatment versus investigator's choice of rituximab combined with either idelalisib or bendamustine
- A sub-analysis from the head-to-head ELEVATE-RR trial for Calquence versus ibrutinib in relapsed or refractory CLL will further characterise adverse events related to Bruton's tyrosine kinase (BTK) inhibition
- A matching-adjusted indirect comparison using data from the ELEVATE-TN trial will compare the safety profile of Calquence alone or in combination with obinutuzumab to either ibrutinib monotherapy or venetoclax in combination with obinutuzumab
- Preclinical data will be presented showing that capivasertib (AZD5363), an AKT inhibitor being evaluated in a number of solid and haematological tumours, showed significant activity in murine DLBCL models when combined with venetoclax. This data continues to broaden our understanding of the role of AKT inhibitors in B-cell non-Hodgkin lymphomas (NHL). Capivasertib monotherapy is being explored in sub-sets of relapsed or refractory B-cell NHL in the CAPITAL Phase II trial
- Additionally, new data will demonstrate AZD4573, a highly selective and potent cyclin dependent kinase 9 inhibitor from AstraZeneca's cell death portfolio, effectively induces apoptosis in vivo in relapsed or refractory MCL xenograft models both alone and when combined with Calquence
Key AstraZeneca presentations during the 63rd ASH Annual Meeting[i]
Lead author Abstract title Presentation details
Jurczak, W Three-Year Abstract # 393Oral Session: 642. Chronic
Follow-Up of the Lymphocytic Leukemia: Clinical and
ASCEND Trial Epidemiological I12 December 202110:00
Investigating ETLocation: Room B401-B402
Seymour, JF Characterization Abstract # 3721Poster Session: 642. Chronic
of Bruton Lymphocytic Leukemia: Clinical and
Tyrosine Kinase Epidemiological: Poster III13 December
Inhibitor (BTKi) 202118:00-20:00 ETLocation: Hall B5
Events in a Head
Sharma, S New Abstract # 4365Online only
with Proton Pump
Davids, MS MAJIC: A Phase 3 Abstract # 1553Poster Session: 642. Chronic
Prospective, Lymphocytic Leukemia: Clinical and
Multicenter, Epidemiological: Poster I11 December
Randomized, Open 202117:30-19:30 ETLocation: Room B5
-Label Trial of
Davids, MS Matching Abstract # 2633Poster Session: 642. Chronic
-Adjusted Lymphocytic Leukemia: Clinical and
Indirect Epidemiological: Poster II12 December
Treatment 202118:00-20:00 ETLocation: Room B5
Alone or in
Seymour, JF A Quality Abstract # 3722Poster Session: 642. Chronic
-Adjusted Lymphocytic Leukemia: Clinical and
Survival (Q Epidemiological: Poster III13 December
-TWiST) Analysis 202118:00-20:00 ETLocation: Room B5
ry (R/R) Chronic
Roschewski, M Phase 2 Study of Abstract # 524Oral Session: 626. Aggressive
Acalabrutinib Lymphomas Prospective Therapeutic Trials:
Window Prior to Novel Agents and Combinations12 December
Frontline 202116:45 ETLocation: Thomas Murphy
Therapy in Ballroom 1-2
Diffuse Large B
Willis, B Combination Abstract # 802Poster Session: 802. Chemical
benefit of Biology and Experimental Therapeutics:
capivasertib and Poster I11 December 202117:30-19:30
venetoclax in ETLocation: Room B5
Diffuse Large B
Roderick, J AZD4573 Abstract # 605Poster Session: 605.
effectively Molecular Pharmacology and Drug Resistance:
induces Lymphoid Neoplasms: Poster II12 December
apoptosis in r/r 202118:00-20:00 ETLocation: Room B5
MCL as a
[i]28 company-sponsored or supported abstracts will be presented at ASH 2021.
Calquence (acalabrutinib) is a next-generation, selective inhibitor of BTK. It binds covalently to BTK, thereby inhibiting its activity.[1,2] In B-cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion.
Calquence is approved for the treatment of CLL and small lymphocytic lymphoma (SLL) in the US, approved for CLL in the EU and several other countries worldwide, and approved in Japan for relapsed or refractory CLL and SLL. A Phase I trial is currently underway in Japan for the treatment of front-line CLL.
In the US and several other countries, Calquence is also approved for the treatment of adult patients with MCL who have received at least one prior therapy. The US MCL indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Calquence is not currently approved for the treatment of MCL in Europe or Japan.
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 evaluated for the treatment of multiple B-cell blood cancers including CLL, MCL, DLBCL, Waldenström's macroglobulinaemia, follicular lymphoma and other haematologic malignancies.
AstraZeneca in haematology
AstraZeneca is pushing the boundaries of science to redefine care in haematology. Applying our deep understanding of blood cancers and leveraging our strength in solid tumour oncology, we are driving the development of novel therapies designed to target underlying drivers of disease across six scientific platforms.
By addressing blood cancers with high unmet medical needs, our aim is to deliver innovative medicines and approaches to healthcare services that have a meaningful impact on patients and caregivers, transforming the haematologic cancer care experience.
AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.
The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.
AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including 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 (https://www.astrazeneca.com/) and follow the Company on Twitter
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1. CALQUENCE (acalabrutinib) [U.S. prescribing information]. Wilmington, DE; AstraZeneca Pharmaceuticals LP; 2019.
2. Wu J, et al. Acalabrutinib (ACP-196): a selective second-generation BTK inhibitor. J Hematol Oncol. 2016;9(21).