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 July
2020
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 receives positive CHMP opinion for
CLL
27 July 2020 07:10 BST
Calquence recommended for approval in the EU by CHMP
for chronic lymphocytic leukaemia
Recommendation based on two Phase III trials demonstrating superior
progression-free survival across multiple settings while
maintaining favourable tolerability
AstraZeneca's Calquence (acalabrutinib) has been recommended for
marketing authorisation in the European Union (EU) for the
treatment of adult patients with chronic lymphocytic leukaemia
(CLL), the most common type of leukaemia in
adults.1
The Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) based its positive opinion on
results from two Phase III clinical trials, ELEVATE TN in patients
with previously untreated CLL, and ASCEND in patients with relapsed
or refractory CLL.
In the ELEVATE TN trial, Calquence combined with obinutuzumab and as
monotherapy reduced the risk of disease progression or death by 90%
and 80%, respectively, compared to standard chemo-immunotherapy
treatment chlorambucil plus obinutuzumab, in patients with
previously untreated CLL.2 In
the ASCEND trial, 88% of patients with relapsed or refractory CLL
taking Calquence remained alive and free from disease
progression after 12 months compared to 68% of patients on
rituximab combined with idelalisib or
bendamustine.3
Across both trials, the safety and tolerability
of Calquence were consistent with its known
profile.2,3
José Baselga, Executive Vice President, Oncology R&D said:
"With its outstanding efficacy and tolerability
profile, Calquence can offer important advantages to patients
with chronic lymphocytic leukaemia who are typically older, facing
multiple comorbidities and often require treatment for many years.
This positive recommendation brings us closer to providing a
much-needed new treatment option to patients in Europe who are
suffering from this chronic blood cancer."
The CHMP recommendation is for Calquence monotherapy or in combination with
obinutuzumab for the treatment of adult patients with previously
untreated CLL and for Calquence monotherapy for the treatment of adult
patients with CLL who have received at least one prior
therapy.
Calquence is approved in
the US and in several other countries around the world for the
treatment of adult patients with CLL and for adult patients with
mantle cell lymphoma (MCL) who have received at least one prior
therapy. Calquence is not approved for MCL in
Europe.
Chronic lymphocytic leukaemia
Chronic lymphocytic leukaemia (CLL) is the most common type of
leukaemia in adults, with an estimated 105,000 new cases globally
in 2016, and the number of people living with CLL is expected to
grow with improved treatment as patients live longer with the
disease.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. 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 Bruton's tyrosine kinase is one of the
essential growth pathways for CLL.
ELEVATE TN
ELEVATE TN (ACE-CL-007) was a randomised, multicentre, open-label
Phase III trial evaluating the safety and efficacy
of Calquence in combination with obinutuzumab, a CD20
monoclonal antibody, or Calquence alone
versus chlorambucil, a chemotherapy, in combination with
obinutuzumab in previously untreated patients with CLL. Patients 65
years of age or older, or between 18 and 65 years of age with a
total Cumulative Illness Rating Scale (CIRS) >6 or creatinine
clearance of 30 to 69mL/min, were enrolled. 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 approximately every 12 hours until
disease progression or unacceptable toxicity) in combination with
obinutuzumab. Patients in the third arm
received Calquence monotherapy (100mg approximately every 12
hours until disease progression or unacceptable
toxicity).2,7
The primary endpoint was 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 was
IRC-assessed PFS in the Calquence monotherapy arm compared to the chlorambucil
and obinutuzumab arm. Other secondary endpoints included objective
response rate, time to next treatment and overall
survival.2,7
ASCEND
ASCEND (ACE-CL-309) was 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 arms.
Patients in the first arm received Calquence monotherapy (100mg twice daily until disease
progression or unacceptable toxicity). Patients in the second arm
received investigator's choice of either rituximab, a CD20
monoclonal antibody, in combination with idelalisib, a PI3K
inhibitor, or rituximab in combination with bendamustine, a
chemotherapy.3,7
The primary endpoint was PFS assessed by an IRC, and key secondary
endpoints included 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.3,7
Calquence
Calquence (acalabrutinib)
is a next-generation, selective inhibitor of Bruton's tyrosine
kinase (BTK). Calquence binds covalently to BTK, thereby inhibiting
its activity.7,8 In
B-cells, BTK signalling results in activation of pathways necessary
for B-cell proliferation, trafficking, chemotaxis, and
adhesion.7
Calquence is approved in
the US and in several countries around the world for the treatment
of adult patients with chronic lymphocytic leukaemia
(CLL) and for 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. As part of an extensive clinical
development programme, AstraZeneca and Acerta Pharma are currently
evaluating Calquence in 23 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 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 by
the US Food and Drug Administration 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 six 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. In
addition to AstraZeneca's main capabilities, the Company is
actively pursuing innovative partnerships and investments 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.
AstraZeneca
AstraZeneca (LSE/STO/NYSE: 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 and 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. American Cancer Society. What is Chronic Lymphocytic Leukemia?
Available at https://www.cancer.org/cancer/chronic-lymphocytic-leukemia/about/what-is-cll.html.
Accessed June 2020.
2. Sharman
JP, et
al.
ELEVATE TN: Phase 3 Study of Acalabrutinib Combined with
Obinutuzumab (O) or Alone Vs O Plus Chlorambucil (Clb) in Patients
(Pts) with Treatment-Naive Chronic Lymphocytic Leukemia
(CLL). Blood. 2019;
134 (Supplement_1): 31.
doi:10.1182/blood-2019-128404.
3. Ghia
P, et
al.
ASCEND: Phase III, Randomized Trial of Acalabrutinib Versus
Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in
Relapsed or Refractory Chronic Lymphocytic Leukemia [published
online ahead of print, 2020 May 27]. J
Clin Oncol. 2020; JCO1903355.
doi:10.1200/JCO.19.03355.
4. National Cancer Institute. Chronic Lymphocytic Leukemia
Treatment (PDQ®)-Patient Version. Available
at https://www.cancer.gov/types/leukemia/patient/cll-treatment-pdq.
Accessed June 2020.
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 2016. JAMA Oncol. 2018;4(11):1553-1568.
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.
7. Calquence® (acalabrutinib)
[prescribing information]. Wilmington, DE; AstraZeneca
Pharmaceuticals LP; 2019.
8. 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:
27 July 2020
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
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