Blueprint
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 June
2019
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
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United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Calquence Phase III
ELEVATE-TN trial met primary
This announcement contains inside
information
6 June 2019 07:00 BST
Calquence Phase III ELEVATE-TN trial met primary
endpoint at interim
analysis in previously-untreated chronic lymphocytic
leukaemia
Calquence alone or in combination significantly
increased
the time patients lived without disease progression
AstraZeneca today announced
positive results from the Phase III ELEVATE-TN
trial of Calquence(acalabrutinib) in patients
with previously-untreated chronic lymphocytic leukaemia
(CLL), the most common type of leukaemia in
adults.1 This
is the second Calquence pivotal trial in CLL to meet its primary
endpoint early, following the positive results of the ASCEND
trial, announced in
May.
The trial met its primary endpoint; Calquence in combination with obinutuzumab
demonstrated astatistically-significant and
clinically-meaningful improvement
in progression-free survival (PFS) when compared with the
chemotherapy-based combination of chlorambucil and
obinutuzumab.
The trial also met a key secondary endpoint
showing Calquence monotherapy achieved
a statistically-significant and clinically-meaningful
improvement in PFS compared to
the chemotherapy and obinutuzumab regimen.
The
safety and tolerability of Calquence was consistent with its
established profile.
José Baselga, Executive Vice President, Oncology R&D said:
"These findings confirm the superiority of Calquence as a monotherapy and also in combination
over standard-of-care treatments for chronic lymphocytic leukaemia.
The positive results from both the ELEVATE-TN and ASCEND trials
will serve as the foundation for regulatory submissions later this
year."
AstraZeneca plans to present detailed results from ELEVATE-TN at a
forthcoming medical meeting. Additionally, AstraZeneca will
present full results from the Phase III ASCEND clinical trial in
relapsed or refractory CLL as a late-breaking abstract at the
upcoming European Hematology Association (EHA) Annual Congress on
16 June 2019 (Abstract #LB2606).
Calquence is currently
approved for the treatment of adults with relapsed or
refractory mantle cell lymphoma (MCL) in the US, Brazil, the
UAE, and Qatar and is being developed for the treatment of CLL and
other blood cancers.
About ELEVATE-TN
ELEVATE-TN (ACE-CL-007) is a randomised, multicentre, open-label
Phase III trial evaluating the safety and efficacy
of Calquence alone or in combination with obinutuzumab
vs. chlorambucil in combination with obinutuzumab in
previously-untreated patients with CLL. In the trial, 535 patients
were randomised (1:1:1) into three arms. Patients in the first arm
received chlorambucil in combination with obinutuzumab. Patients in
the second arm received Calquence (100mg twice daily until disease
progression) in combination with obinutuzumab. Patients in the
third arm received Calquence monotherapy (100mg twice daily until disease
progression).2
The primary endpoint is PFS in the Calquence and obinutuzumab arm compared to the
chlorambucil and obinutuzumab arm, assessed by an independent
review committee (IRC), and a key secondary endpoint is
IRC-assessed PFS in the Calquence monotherapy arm compared to the chlorambucil
and obinutuzumab arm. Other secondary endpoints include objective
response rate, time to next treatment and overall
survival.2
About Calquence
Calquence (acalabrutinib)
was granted accelerated approval by the US Food and Drug
Administration (FDA) in October 2017 for the treatment of adult
patients with 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.
Calquence is an inhibitor
of Bruton tyrosine kinase (BTK). Calquence binds covalently to BTK, thereby inhibiting
its activity.3 In
B-cells, BTK signalling results in activation of pathways necessary
for B-cell proliferation, trafficking, chemotaxis, and
adhesion.
As part of an extensive clinical development programme, AstraZeneca
and Acerta Pharma are currently evaluating Calquence in 26 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, Waldenstrom macroglobulinaemia, follicular
lymphoma, and multiple myeloma and other haematologic malignancies.
Several Phase III clinical trials in CLL are ongoing, including
ASCEND, ELEVATE-TN, ELEVATE-RR (ACE-CL-006) evaluating
acalabrutinib vs. ibrutinib in patients with previously-treated
high-risk CLL, and ACE-CL-311 evaluating acalabrutinib in
combination with venetoclax and with/without obinutuzumab in
patients with previously-untreated CLL without 17p deletion or TP53
mutation.
About chronic lymphocytic leukaemia
Chronic lymphocytic leukaemia (CLL) is the most common type of
leukaemia in adults, with an estimated 191,000 new cases globally
and 20,720 new cases in the US annually, and prevalence that is
expected to grow with improved treatment.1,4,5,6 In
CLL, too many blood stem cells in the bone marrow become abnormal
lymphocytes and these abnormal cells have difficulty fighting
infections.1 As
the number of abnormal cells grows there is less room for healthy
white blood cells, red blood cells and
platelets.1 This
could result in anaemia, infection and bleeding.1 B-cell
receptor signalling through BTK is one of the essential growth
pathways for CLL.
About 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 US FDA-approved
medicines 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.
In October 2018, AstraZeneca and Innate
Pharma announced a global
strategic collaboration that included Innate
Pharma licensing the US
commercial rights of Lumoxiti (moxetumomab pasudotox-tdfk), and with
support from AstraZeneca, will continue EU development and
commercialisation, pending regulatory submission and
approval.
About 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 at
least six new medicines to be launched between 2014 and 2020, and a
broad pipeline of small molecules and biologics in development, we
are committed to advance oncology as a key growth driver for
AstraZeneca 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 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, Renal &
Metabolism and Respiratory. 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.
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Adrian Kemp
Company Secretary
AstraZeneca PLC
References
1 National Cancer Institute. Chronic Lymphocytic Leukemia
Treatment (PDQ®)-Patient Version. Available online. Accessed
May 2019.
2 ClinicalTrials.gov. Elevate CLL TN: Study of Obinutuzumab +
Chlorambucil, Acalabrutinib (ACP-196) + Obinutuzumab, and
Acalabrutinib in Subjects With Previously Untreated CLL.
NCT02475681. Available online. Accessed May 2019.
3 CALQUENCE (acalabrutinib) Prescribing Information. AstraZeneca
Pharmaceuticals LP, Wilmington, DE.
4 Global Burden of Disease Cancer
Collaboration. JAMA Oncol. 2017;3(4):524-528.
5 National Institute of Health SEER Program. Cancer Stat Facts:
Leukemia-Chronic Lymphocytic Leukemia (CLL). Available online.
Accessed May 2019.
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.
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:
06 June
2019
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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