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 August
2019
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
granted US Breakthrough Therapy Designation
14 August 2019 07:00 BST
Calquence granted
US Breakthrough Therapy Designation
for chronic lymphocytic
leukaemia
Designation based on positive results from two Phase III
trials
AstraZeneca today announced that the US Food and Drug
Administration (FDA) has granted Breakthrough Therapy Designation
(BTD) for Calquence (acalabrutinib) as a monotherapy treatment
for adult patients with chronic lymphocytic leukaemia (CLL), one of
the most common types of leukaemia in adults.1
José Baselga, Executive Vice President, Oncology R&D,
said: "This is an important regulatory milestone for our work in
haematology and for patients living with chronic lymphocytic
leukaemia, a life-threatening disease. The Breakthrough Therapy
Designation acknowledges the growing body of evidence that
supports Calquence as a highly-selective Bruton tyrosine kinase
inhibitor with the potential to offer patients a new,
differentiated, chemotherapy-free treatment option with a
favourable safety profile."
The FDA granted the BTD based on positive results from the interim
analyses of the ELEVATE-TN and ASCEND Phase
III clinical trials. Together the trials showed
that Calquence alone or in combination significantly
increased the time patients lived without disease progression or
death, with safety and tolerability that was consistent with its
established profile.
This is
the 10th BTD that AstraZeneca has received from the FDA since
2014. An FDA BTD is designed to
accelerate the development and regulatory review of new medicines
that are intended to treat a serious condition and that have shown
encouraging early clinical results which may demonstrate
substantial improvement on a clinically-significant endpoint over
currently-available medicines.
Calquence is currently
approved for the treatment of adults with relapsed or
refractory mantle cell lymphoma (MCL) in the US, Brazil,
Qatar, the United Arab Emirates, Mexico, Argentina and recently
Singapore and is being developed for the treatment of CLL and other
blood cancers. The positive results from both the
ELEVATE-TN and ASCEND trials will serve as the foundation for
regulatory submissions later this year.
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
or unacceptable toxicity) in combination with obinutuzumab.
Patients in the third arm received Calquence monotherapy (100mg twice daily until disease
progression or unacceptable toxicity).2
The primary endpoint is progression-free survival (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 ASCEND
ASCEND (ACE-CL-309) is a global, randomised, multicentre,
open-label Phase III trial evaluating the efficacy
of Calquence in previously-treated patients with
CLL.2 In
the trial, 310 patients were randomised (1:1) into two arms.
Patients in the first arm received Calquence monotherapy (100mg twice daily until disease
progression or unacceptable toxicity). Patients in the second arm
received physician's choice of either rituximab in combination with
idelalisib or rituximab in combination with
bendamustine.3,4
The primary endpoint is PFS assessed by an IRC, and key secondary
endpoints include physician-assessed PFS, IRC- and
physician-assessed overall response rate and duration of response,
as well as overall survival, patient-reported outcomes and time to
next treatment.3,4
About Calquence
Calquence (acalabrutinib)
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. 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.5 In
beta (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, Waldenström 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 one of the most common type
of leukaemia in adults, with an estimated 105,000 new cases
globally and 20,720 new cases in the US annually, and prevalence
that is expected to grow with improved
treatment.1,6,7,8 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, the
Company is committed to advance oncology as a key growth driver for
AstraZeneca focused on lung, ovarian, breast and blood cancers. In
addition to AstraZeneca's main capabilities, the Company is
actively pursuing innovative partnerships and investment that
accelerate the delivery of our strategy, as illustrated by the
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, CVRM and Respiratory. AstraZeneca
operates in over 100 countries and its innovative medicines are
used by millions of patients worldwide. For more information,
please visit astrazeneca.com and
follow us on Twitter @AstraZeneca.
Media Relations
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Gonzalo
Viña
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+44 203 749 5916
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Rob
Skelding
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Oncology
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+44 203 749 5821
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Rebecca
Einhorn
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Oncology
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+1 301 518 4122
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Matt
Kent
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BioPharmaceuticals
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+44 203 749 5906
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Jennifer
Hursit
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Other
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+44 203 749 5762
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Christina
Malmberg Hägerstrand
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Sweden
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+46 8 552 53 106
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Michele
Meixell
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US
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+1 302 885 2677
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Investor Relations
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Thomas
Kudsk Larsen
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+44 203 749 5712
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Henry
Wheeler
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Oncology
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+44 203 749 5797
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Christer
Gruvris
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BioPharmaceuticals (cardiovascular, metabolism)
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+44 203 749 5711
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Nick
Stone
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BioPharmaceuticals (respiratory, renal)
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+44 203 749 5716
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Josie
Afolabi
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Other medicines
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+44 203 749 5631
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Craig
Marks
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Finance, fixed income
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+44 7881 615 764
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Kretzmann
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Corporate access, retail investors
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US
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Adrian Kemp
Company Secretary
AstraZeneca PLC
References
1. American Cancer Society. Cancer Facts & Figures. Available
online. Accessed July 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 July 2019.
3. Ghia P, Pluta A, Wach M, et al. ASCEND Phase 3 study of
acalabrutinib vs. investigator's choice of rituxumab plus
idelalisib (idR) or bendamustine (BR) in patients with
relapsed/refractory (R/R) chronic lymphocytic leukaemia (CLL).
Abstract LB2606 at: European Hematology Association 2019 Annual
Meeting. Available online. Accessed July 2019.
4. ClinicalTrials.gov. A Study of Acalabrutinib vs Investigator's
Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab
in R/R CLL. NCT02970318. Available online. Accessed June
2019.
5. CALQUENCE (acalabrutinib) Prescribing Information. AstraZeneca
Pharmaceuticals LP, Wilmington, DE.
6. Global Burden of Disease Cancer
Collaboration. JAMA Oncol. 2017;3(4):524-528.
7. National Institute of Health SEER Program. Cancer Stat Facts:
Leukemia-Chronic Lymphocytic Leukemia (CLL). Available online.
Accessed July 2019.
8. 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:
14 August
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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