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 May
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
Calquence
PhIII ASCEND trial met primary endpoint
7 May 2019 07:00 BST
Calquence Phase III ASCEND trial met primary endpoint
at interim analysis
in relapsed or refractory chronic lymphocytic leukaemia and will
stop early
Calquence significantly increased the
time
patients live without disease progression
AstraZeneca
today announced positive results from the Phase III ASCEND
trial of Calquence(acalabrutinib) in
previously-treated patients with chronic lymphocytic leukaemia
(CLL). Results showed a statistically-significant and
clinically-meaningful improvement in progression-free survival
(PFS) with Calquence monotherapy compared to
a combination regimen of rituximab plus physician's choice of
idelalisib or bendamustine. Importantly, the safety and
tolerability of Calquence was consistent with the
known profile.
José Baselga, Executive Vice President, R&D Oncology said:
"Calquence is the first BTK inhibitor to show benefit
in a Phase III trial as a monotherapy compared to current
standard-of-care combinations used in relapsed or
refractory chronic lymphocytic leukaemia. We look forward to
presenting detailed results at a forthcoming medical
meeting."
Within AstraZeneca's robust development programme
for Calquence, ASCEND is the first of two Phase III CLL
trials expected to read out in 2019. The second is ELEVATE-TN
(ACE-CL-007) in treatment-naïve, front-line
CLL. Calquence is currently approved for the treatment of
adults with relapsed or refractorymantle 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 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. In
the trial, 310 patients were randomised (1:1) into two groups.
Patients in the first group received Calquence monotherapy (100mg twice daily until disease
progression). Patients in the second group received rituximab plus
physician's choice of idelalisib or
bendamustine.1
The primary endpoint is PFS assessed by an independent review
committee (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
(TTNT).1
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 activity2.
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 clinical trials that are
company-sponsored. 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 Calquence vs. ibrutinib in previously-treated CLL and
ACE-CL-311 evaluating Calquence in combination with venetoclax and
obinutuzumab in previously-untreated fit patients with
CLL.
About chronic lymphocytic leukaemia (CLL)
CLL is the most common type of leukaemia in
adults3.
In the US, it accounts for approximately one in four new cases of
leukaemia, with the average age at the time of diagnosis being
approximately 70 years of age4.
In CLL, too many blood stem cells in the bone marrow become
abnormal lymphocytes and these abnormal cells have difficulty
fighting infections3.
As the number of abnormal cells grows there is less room for
healthy white blood cells, red blood cells and
platelets3.
This could result in anaemia, infection and
bleeding3.
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 astrazeneca.com and
follow us on Twitter @AstraZeneca.
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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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BioPharma
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Hursit
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Other
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Meixell
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US
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Investor Relations
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Thomas
Kudsk Larsen
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Henry
Wheeler
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Oncology
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+44 203 749 5797
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Gruvris
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BioPharma (cardiovascular; metabolism)
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+44 203 749 5711
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Nick
Stone
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BioPharma (respiratory, renal)
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+44 203 749 5716
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Adrian Kemp
Company Secretary
AstraZeneca PLC
References
1 Data on file
2 Calquence (acalabrutinib) Prescribing Information.
AstraZeneca Pharmaceuticals LP, Wilmington, DE, USA
3 National Cancer Institute. Chronic Lymphocytic Leukemia
Treatment (PDQ)-Patient Version. Available online. Accessed April
2019
4 American Cancer Society. What are the key statistics for
chronic lymphocytic leukemia? Available online. Accessed April
2019
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:
07 May
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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