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2019-05-07

AstraZeneca: Calquence Phase III ASCEND trial met primary endpoint at interim analysis in relapsed or refractory chronic ly...

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 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 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
(https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2...)
a global strategic collaboration that included Innate Pharma
(http://innate-pharma.com/) 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
(http://www.astrazeneca.com/) and follow us on Twitter @AstraZeneca
(https://twitter.com/AstraZeneca).

Media Relations
Gonzalo Viña +44 203 749 5916
Rob Skelding Oncology +44 203 749 5821
Rebecca Einhorn Oncology +1 301 518 4122
Matt Kent BioPharma +44 203 749 5906
Jennifer Hursit Other +44 203 749 5762
Christina Sweden +46 8 552 53 106
Malmberg
Hägerstrand
Michele US +1 302 885 2677
Meixell

Investor
Relations
Thomas Kudsk +44 203 749 5712
Larsen
Henry Wheeler Oncology +44 203 749 5797
Christer BioPharma (cardiovascular; metabolism) +44 203 749 5711
Gruvris
Nick Stone BioPharma (respiratory, renal) +44 203 749 5716
Josie Afolabi Other medicines +44 203 749 5631
Craig Marks Finance, fixed income +44 7881 615 764
Jennifer Corporate access, retail investors +44 203 749 5824
Kretzmann
US toll-free +1 866 381 72 77

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

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