FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of January 2021
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Calquence met primary
efficacy endpoint in head-to-head trial against ibrutinib in
chronic lymphocytic leukaemia
25 January 2021 07:00 GMT
Calquence met primary efficacy endpoint in
head-to-head trial against ibrutinib in chronic lymphocytic
leukaemia
Superior safety on key secondary endpoint of atrial
fibrillation
Positive high-level results from the ELEVATE-RR Phase III trial
showed AstraZeneca's Calquence (acalabrutinib) met the primary endpoint
demonstrating non-inferior progression-free survival (PFS) for
adults with previously treated, high-risk chronic lymphocytic
leukaemia (CLL) compared to ibrutinib.
The trial also met a key secondary endpoint for safety, showing
patients treated with Calquence had statistically significantly lower
incidence of atrial fibrillation compared to patients treated with
ibrutinib. Atrial fibrillation is an
irregular heart rate that can increase the risk of stroke, heart
failure and other heart-related complications.1 Further
hierarchical testing revealed no difference for Grade 3 or higher
infections or Richter's transformation. There was a descriptive
trend for numerically favourable overall survival. Overall, the
safety and tolerability of Calquence were consistent with the profile seen in the
broader Calquence clinical development
programme.
ELEVATE-RR is the first Phase III trial to compare two Bruton's
tyrosine kinase (BTK) inhibitors in patients with CLL, the most
common type of leukaemia in adults.2 Patients
diagnosed with high-risk CLL may experience rapid worsening of
their disease, requiring treatment.3
José Baselga, Executive Vice President, Oncology R&D,
said: "With over forty months of follow-up, today's results confirm
that Calquence, a selective BTK inhibitor, displays superior
safety in atrial fibrillation without compromising
efficacy. The totality of the data confirm our
confidence in the favourable benefit-risk profile
of Calquence."
The data will be presented at a forthcoming medical meeting and
shared with health authorities.
CLL
CLL is the most common type of leukaemia in adults, with an
estimated 114,000 new cases globally in 2017, and the number of
people living with CLL is expected to grow with improved treatment
as patients live longer with the disease.2,4-6 In
CLL, too many blood stem cells in the bone marrow become abnormal
lymphocytes and these abnormal cells have difficulty fighting
infections. As the number of abnormal cells grows, there is less
room for healthy white blood cells, red blood cells, and platelets.
This could result in anaemia, infection, and
bleeding.4 B-cell
receptor signalling through BTK is one of the essential growth
pathways for CLL.
ELEVATE-RR
ELEVATE-RR (ACE-CL-006) is a randomised, multicentre, open-label
Phase III non-inferiority trial of Calquence versus ibrutinib in patients with previously
treated CLL with high-risk features (presence of 17p deletion
and/or 11q deletion). In the trial, 533 patients were randomised
(1:1) into two arms. Patients in the first arm
received Calquence (100mg orally twice daily) until disease
progression or unacceptable toxicity. Patients in the second arm
received ibrutinib (420mg orally once daily) until disease
progression or unacceptable toxicity.7
The primary endpoint for the trial was PFS assessed by an
independent review committee (non-inferiority; tested after 250
events). Secondary endpoints included incidence of atrial
fibrillation, incidence of treatment-emergent Grade 3 or higher
infections, incidence of Richter's transformation (a condition in
which CLL changes into an aggressive form of lymphoma) and overall
survival.7
Calquence
Calquence (acalabrutinib)
is a next-generation, selective inhibitor of
BTK. Calquence binds covalently to BTK, thereby inhibiting
its activity.8,9 In
B-cells, BTK signalling results in activation of pathways necessary
for B-cell proliferation, trafficking, chemotaxis, and
adhesion.8
Calquence is approved for
the treatment of CLL and small lymphocytic lymphoma in the US and
approved for CLL in the EU and several other countries
worldwide. Calquence is under regulatory review in Japan for
relapsed or refractory CLL. A Phase I trial is currently
underway in Japan for the treatment of 1st-line
CLL.
In the US and several other countries, Calquence is also approved for the treatment of adult
patients with mantle cell lymphoma (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 developed for the treatment of
multiple B-cell blood cancers including CLL, MCL, diffuse large
B-cell lymphoma, Waldenström's macroglobulinaemia, follicular
lymphoma, and other haematologic malignancies.
AstraZeneca in haematology
Leveraging its strength in oncology, AstraZeneca has established
haematology as one of four key oncology disease areas of focus. The
Company's haematology franchise includes two medicines approved in
the US and a robust global development programme for a broad
portfolio of potential blood cancer treatments. Acerta Pharma
serves as AstraZeneca's haematology research and development arm.
AstraZeneca partners with like-minded science-led companies to
advance the discovery and development of therapies to address unmet
need.
AstraZeneca in oncology
AstraZeneca has a deep-rooted heritage in oncology and offers a
quickly growing portfolio of new medicines that has the
potential to transform patients' lives and the Company's future.
With seven new medicines launched between 2014 and 2020, and a
broad pipeline of small molecules and biologics in
development, the Company is committed to advance oncology as a key
growth driver for AstraZeneca focused on lung, ovarian, breast and
blood cancers.
By harnessing the power of six scientific platforms -
Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage
Response, Antibody Drug Conjugates, Epigenetics, and Cell Therapies
- 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.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) 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, 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 and
follow the Company on Twitter @AstraZeneca.
Contacts
For details on how to contact the Investor Relations Team, please
click here. For Media contacts, click here.
References
1. Mayo Clinic. Patient Care & Health Information, Diseases
& Conditions - Atrial Fibrillation.
Available at: https://www.mayoclinic.org/diseases-conditions/atrial-fibrillation/symptoms-causes/.
Accessed January 2021.
2. American Cancer Society. What is Chronic Lymphocytic Leukemia.
Available at: https://www.cancer.org/cancer/chronic-lymphocytic-leukemia/about/what-is-cll.html.
Accessed January 2021.
3. Cancer.net. Leukemia-Chronic Lymphocytic - CLL: Stages.
Available at: https://www.cancer.net/cancer-types/leukemia-chronic-lymphocytic-cll/stages.
Accessed January 2021.
4. National Cancer Institute. Chronic Lymphocytic Leukemia
Treatment (PDQ®)-Patient
Version. Available at: https://www.cancer.gov/types/leukemia/patient/cll-treatment-pdq.
Accessed January 2021.
5. Global Burden of Disease Cancer Collaboration. Global, Regional,
and National Cancer Incidence, Mortality, Years of Life Lost, Years
Lived With Disability, and Disability-Adjusted Life-Years for 29
Cancer Groups, 1990 to 2017. JAMA Oncol. 2019;5(12):1749-1768.
6. Jain N, et al. Prevalence and Economic Burden of Chronic
Lymphocytic Leukemia (CLL) in the Era of Oral Targeted
Therapies. Blood. 2015;126:871.5.
7. Clinicaltrials.gov. NCT02477696. Accessed September 18, 2020.
Study started in October 2015.
8. CALQUENCE (acalabrutinib) [U.S. prescribing information].
Wilmington, DE; AstraZeneca Pharmaceuticals LP; 2019.
9. Wu J, Zhang M & Liu D. Acalabrutinib (ACP-196): a selective
second-generation BTK inhibitor. J Hematol
Oncol. 2016;9(21).
Adrian Kemp
Company Secretary
AstraZeneca PLC
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
Date:
25 January
2021
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
|
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