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 July
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
Imfinzi
granted US Orphan Drug Designation for small cell lung
cancer
12 July
2019 07:00 BST
Imfinzi granted US Orphan Drug
Designation for small cell lung
cancer
AstraZeneca today announced that the US Food and Drug
Administration (FDA) has granted Orphan Drug Designation (ODD)
to Imfinzi (durvalumab) for the treatment of small cell
lung cancer (SCLC).
SCLC constitutes about 15% of all lung cancer diagnoses. It is the
most aggressive type of lung cancer with only 6% of patients alive
after five years. The FDA grants ODD status to medicines and
potential new medicines intended for the treatment, diagnosis or
prevention of rare diseases or disorders that affect fewer than
200,000 people in the US.
In June 2019, the Phase III CASPIAN
trial met its primary
endpoint with Imfinzi by showing a statistically-significant and
clinically-meaningful improvement in overall survival for patients
with extensive-stage SCLC. These patients were treated
with Imfinzi in combination with standard-of-care
etoposide and platinum-based chemotherapy vs. chemotherapy
alone. Results will be shared at a forthcoming medical
meeting. Imfinzi is also being tested following concurrent
chemoradiation therapy in limited-stage SCLC in the Phase III
ADRIATIC trial.
José Baselga, Executive Vice President, R&D Oncology said:
"This Orphan Drug Designation comes on the heels of positive
results from the Phase III CASPIAN trial, which is the first
trial to offer the flexibility of combining immunotherapy with
different platinum-based regimens in small cell lung cancer. We are
eager to expand treatment options for
patients facing such a devastating diagnosis and look
forward to working with regulatory authorities to bring
forward new options as soon as possible."
Imfinzi is currently
approved for unresectable, Stage III non-small cell lung cancer
(NSCLC) after chemotherapy and radiation therapy in more than 45
countries including the US, EU, and Japan based on the Phase III
PACIFIC trial.
About small cell lung cancer
Lung cancer is the leading cause of cancer death among both men and
women and accounts for about one-fifth of all cancer
deaths.1 Lung
cancer is broadly split into NSCLC and SCLC, with about 15%
classified as SCLC.2 About
two-thirds of SCLC patients are diagnosed with extensive-stage
disease, in which the cancer has spread widely through the lung or
to other parts of the body.3 SCLC
is an aggressive, fast-growing cancer that recurs and progresses
rapidly despite initial response to platinum-based
chemotherapy.4 Prognosis
is particularly poor, as only 6% of all SCLC patients will be alive
five years after diagnosis.3
About Imfinzi
Imfinzi (durvalumab) is a
human monoclonal antibody that binds to PD-L1 and blocks the
interaction of PD-L1 with PD-1 and CD80, countering the tumour's
immune-evading tactics and releasing the inhibition of immune
responses.
Imfinzi is also approved
for previously-treated patients with advanced bladder cancer in the
US, Canada, Brazil, Australia, Israel, India, United Arab Emirates,
Qatar, Macau and Hong Kong.
As part of a broad development programme, Imfinzi is also being tested as a monotherapy and in
combination with tremelimumab, an anti-CTLA4 monoclonal antibody
and potential new medicine, as a treatment for patients with NSCLC,
small-cell lung cancer (SCLC), bladder cancer, head and neck
cancer, liver cancer, cervical cancer, biliary tract cancer and
other solid tumours.
About AstraZeneca in lung cancer
AstraZeneca has a comprehensive portfolio of approved and potential
new medicines in late-stage clinical development for the treatment
of different forms of lung cancer spanning several stages of
disease and lines of therapy. We aim to address the unmet needs of
patients with EGFR-mutated tumours as a genetic driver of disease,
which occur in 10-15% of NSCLC patients in the US and EU and 30-40%
of NSCLC patients in Asia, with our approved
medicines Iressa (gefitinib) and Tagrisso (osimertinib) and ongoing Phase III trials
FLAURA, ADAURA and LAURA as well as the Phase II exploratory
combination trials SAVANNAH and ORCHARD.5-7
Our extensive late-stage Immuno-Oncology programme focuses on lung
cancer patients without a known genetic mutation which represents
up to 50% of all patients with lung
cancer. Imfinzi (durvalumab),
an anti-PDL1 antibody is in development as monotherapy (Phase III
trials ADJUVANT BR.31, PACIFIC-4, PACIFIC-5, and PEARL) and in
combination with tremelimumab and/or chemotherapy (AEGEAN,
PACIFIC-2, NEPTUNE, POSEIDON, ADRIATIC and CASPIAN Phase III
trials).
About AstraZeneca's approach to Immuno-Oncology (IO)
IO is a therapeutic approach designed to stimulate the body's
immune system to attack tumours. Our IO portfolio is anchored by
immunotherapies that have been designed to overcome anti-tumour
immune suppression. We believe that IO-based therapies offer the
potential for life-changing cancer treatments for the clear
majority of patients.
We are pursuing a comprehensive clinical-trial programme that
includes Imfinzi (anti-PDL1) as monotherapy and in
combination with tremelimumab (anti-CTLA4) in multiple tumour
types, stages of disease, and lines of therapy, using the PD-L1
biomarker as a decision-making tool to define the best potential
treatment path for a patient. In addition, the ability to combine
our IO portfolio with small, targeted molecules from across our
Oncology pipeline, and from our research partners, may provide new
treatment options across a broad range of
tumours.
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.
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
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Jennifer
Hursit
|
Other
|
+44 203 749 5762
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Christina
Malmberg Hӓgerstrand
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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
|
|
+44 203 749 5712
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Henry
Wheeler
|
Oncology
|
+44 203 749 5797
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Christer
Gruvris
|
BioPharma (cardiovascular; metabolism)
|
+44 203 749 5711
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Nick
Stone
|
BioPharma (respiratory; renal)
|
+44 203 749 5716
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Josie
Afolabi
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Other medicines
|
+44 203 749 5631
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Craig
Marks
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Finance; fixed oncome
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+44 7881 615 764
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Jennifer
Kretzmann
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Corporate access; retail investors
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+44 203 749 5824
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US
toll-free
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+1 866 381 7277
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Adrian Kemp
Company Secretary
AstraZeneca PLC
References
1. World Health Organization. International Agency for Research on
Cancer. Available athttp://globocan.iarc.fr/Pages/fact_sheets_population.aspx.
Accessed May 2019.
2. LUNGevity Foundation. Types of Lung Cancer. Available
at https://lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer.
Accessed May 2019.
3. Cancer.Net. Lung Cancer - Small Cell. Available
at https://www.cancer.net/cancer-types/33776/view-all.
Accessed May 2019.
4. Kalemkerian GP, et al. Treatment Options for Relapsed Small-Cell
Lung Cancer: What Progress Have We Made?Journal of Oncology
Practice, volume 14, issue no.
6 (June 1 2018) 369-370.
5. Szumera-Ciećkiewicz A, et al. EGFR Mutation Testing on Cytological and
Histological Samples in Non-Small Cell Lung Cancer: a Polish,
Single Institution Study and Systematic Review of European
Incidence. Int J Clin Exp
Pathol. 2013:6;2800-12.
Accessed May 2019.
6. Keedy VL, et al. American Society of Clinical Oncology
Provisional Clinical Opinion: Epidermal Growth Factor Receptor
(EGFR) Mutation Testing for Patients with Advanced Non-Small-Cell
Lung Cancer Considering First-Line EGFR Tyrosine Kinase Inhibitor
Therapy. J Clin
Oncol. 2011:29;2121-27.
Accessed May 2019.
7. Ellison G, et al. EGFR Mutation Testing in Lung Cancer: a
Review of Available Methods and Their Use for Analysis of Tumour
Tissue and Cytology Samples. J Clin
Pathol. 2013:66;79-89. Accessed
May 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:
12 July
2019
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
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|
Title:
Company Secretary
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