AstraZeneca’s Calquence (acalabrutinib) Shows Potential in Chronic Lymphocytic Leukaemia Trials
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. |
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Contact information
AstraZeneca
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Mike Hayes, +1
301-398-0221
Hugues Joublin, +1 301-398-3041
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