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 January 2021
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
approved in Japan for CLL
25 January 2021 07:05 GMT
Calquence approved
in Japan for the treatment of
relapsed or refractory chronic lymphocytic leukaemia
88% of patients on Calquence remained free of disease
progression after 12 months vs. 68% for comparators
AstraZeneca's Calquence (acalabrutinib), a next-generation,
selective Bruton's tyrosine kinase (BTK) inhibitor, has been
approved in Japan for the treatment of adult patients
with relapsed or refractory chronic lymphocytic leukaemia
(CLL) (including small lymphocytic
lymphoma [SLL]).
The approval by the Japanese Ministry of Health, Labour
and Welfare was based on positive results from the ASCEND
Phase III trial and a Phase I trial in Japanese patients,
showing Calquence monotherapy demonstrated a statistically
significant and clinically meaningful improvement in
progression-free survival (PFS) versus a standard treatment of
rituximab, a monoclonal antibody, combined with the physician's
choice of idelalisib, a PI3-kinase inhibitor or bendamustine, a
chemotherapy.
In the ASCEND trial, Calquence reduced the risk of disease progression or
death by 69% (hazard ratio, 0.31; 95% confidence interval,
0.20-0.49, p<0.0001). These results were published
in Journal
of Clinical Oncology in
2020.1
CLL is the most common type of adult leukaemia across the globe but
is considered a rare disease in Japan and East Asia, representing
between 1% and 2% of patients diagnosed with
leukaemia.2-4
Dai Maruyama, MD, PhD, Director, Department of Hematology and
Oncology, Cancer Institute Hospital of Japanese Foundation for
Cancer Research, Tokyo, Japan said: "Today's news marks great
progress for patients with chronic lymphocytic leukaemia in Japan.
As the ASCEND trial showed, Calquence provides a significant improvement in
progression-free survival compared with current standard therapies.
Treatment with a safe and tolerable regimen remains paramount for
these patients who often require ongoing therapy for many
years."
Dave Fredrickson, Executive Vice President, Oncology Business Unit,
said: "Chronic lymphocytic leukaemia is less prevalent in Japan
than other regions, yet patients remain in need of innovative
treatment options. This approval of Calquence offers patients in Japan a new, chemo-free,
tolerable treatment option with uncompromised efficacy and the
potential to positively impact quality of
life."
In the ASCEND Phase III trial, an estimated 88% of patients with
relapsed or refractory CLL treated with Calquence remained alive and free from disease
progression after 12 months compared with 68% of patients on
rituximab combined with idelalisib or bendamustine. After a median
follow up of 16.1 months, median PFS was not reached
with Calquence monotherapy versus 16.5 months in the
control arm.1
The safety and tolerability of Calquence were consistent with its established
profile.1 Final
results of the ASCEND Phase III trial were presented at the 2020
American Society of Clinical Oncology and 2020 European Hematology
Association virtual meetings and demonstrated the long-term
(median 22-month follow-up) efficacy and tolerability
of Calquence in CLL.5,6
Calquence is approved for
the treatment of CLL and SLL in the US and
is approved for
the treatment of CLL in the EU and in several other countries
worldwide in the 1st-line and relapsed or refractory
settings. Calquence is also approved in the US and several other
countries for the treatment of adult patients with mantle cell
lymphoma (MCL) who have received at least one prior
therapy. Calquence is not currently approved for the treatment
of MCL in Japan or the EU.
As part of a broad development programme, Calquence is being assessed in more than 20
AstraZeneca-sponsored clinical trials for the treatment of patients
with B-cell malignancies including CLL, MCL, diffuse large B-cell
lymphoma, Waldenström's macroglobulinaemia, follicular
lymphoma, and other haematologic malignancies.
A Japanese Phase I/II trial based on the ELEVATE TN Phase III trial
is currently underway for the treatment of 1st-line
CLL.
CLL
CLL is the most common type of leukaemia in adults, with an
estimated 114,000 new cases globally in 2017, and the number of
people living with CLL is expected to grow with improved treatment
as patients live longer with the disease.7-10 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.7 B-cell
receptor signalling through BTK is one of the essential growth
pathways for CLL.
ASCEND
ASCEND (ACE-CL-309) was a global, randomised, multicentre,
open-label Phase III trial evaluating the efficacy
of Calquence in patients with relapsed or refractory 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 physician's choice of either rituximab, a CD20 monoclonal
antibody, in combination with idelalisib, a PI3-kinase inhibitor,
or rituximab in combination with bendamustine, a
chemotherapy.1
The primary endpoint was PFS assessed by an Independent Review
Committee (IRC), and key secondary endpoints included
investigator-assessed PFS, IRC- and investigator-assessed overall
response rate and duration of response, as well as overall
survival, patient-reported outcomes and time to next
treatment.1 ASCEND
is the first randomised Phase III trial to directly compare a BTK
inhibitor as monotherapy to these combinations in relapsed or
refractory CLL.
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 in
the US 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 seven 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.
By harnessing the power of six scientific platforms -
Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage
Response, Antibody Drug Conjugates, Epigenetics, and Cell Therapies
- 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/Nasdaq: 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 & 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. 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.
2. Mahlich J, Okamoto S,
Tsubota A. Cost of Illness of Japanese Patients with Chronic
Lymphocytic Leukemia (CLL), and Budget Impact of the Market
Introduction of Ibrutinib. Pharmacoecon
Open. 2017;1(3):195-202.
doi:10.1007/s41669-017-0024-5.
3. National Cancer Institute Cancer Information Service. Chronic
Lymphocytic Leukemia/Small Lymphocytic Lymphoma. Available
at: https://ganjoho.jp/public/cancer/CLL/index.html.
Accessed January 2021.
4. Takizawa J, et al. Comparative Analysis of Japanese and European
Typical CLL Patients. Blood. 02 December
2016;128(22):5564.
5. Ghia P, et al.
Acalabrutinib (Acala) vs Idelalisib plus Rituximab (IdR) or
Bendamustine plus Rituximab (BR) in Relapsed/Refractory (R/R)
Chronic Lymphocytic Leukemia (CLL): ASCEND Final Results. Abstract
S159 at the Virtual Edition of the European Hematology Association
25th EHA Annual Congress.
6. Ghia P, et al.
Acalabrutinib Vs Idelalisib Plus Rituximab (IdR) or Bendamustine
Plus Rituximab (BR) in Relapsed/Refractory (R/R) Chronic
Lymphocytic Leukemia (CLL): ASCEND Final Results. Abstract 8015 at
the American Society of Clinical Oncology ASCO20 Virtual
Session.
7. American Cancer Society. What is Chronic Lymphocytic Leukemia?
Available at https://www.cancer.org/cancer/chronic-lymphocytic-leukemia/about/what-is-cll.html.
Accessed January 2021.
8. National Cancer Institute. Chronic Lymphocytic Leukemia
Treatment (PDQ®)-Patient
Version. Available at https://www.cancer.gov/types/leukemia/patient/cll-treatment-pdq.
Accessed January 2021.
9. 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 2017. JAMA Oncol. 2019;5(12):1749-1768.
10. Jain N, et al. Prevalence and Economic Burden of Chronic
Lymphocytic Leukemia (CLL) in the Era of Oral Targeted
Therapies. Blood. 2015;126:871.
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:
25 January 2021
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
|
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