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 October
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
1.
Imfinzi
and Imfinzi plus tremelimumab delayed
This announcement contains inside information
28 October 2019 15:15 GMT
Imfinzi and Imfinzi plus tremelimumab delayed disease
progression in Phase III POSEIDON trial for 1st-line treatment of
Stage IV non-small cell lung cancer
POSEIDON included both non-squamous and squamous
patients and a broad choice of standard chemotherapy
options
AstraZeneca today announced positive progression-free survival
(PFS) results for Imfinzi(durvalumab) and tremelimumab, an anti-CTLA4
antibody, when added to chemotherapy, from the Phase III POSEIDON
trial in previously-untreated Stage IV (metastatic) non-small
cell lung cancer (NSCLC).
The trial met a primary endpoint by showing a statistically
significant and clinically meaningful improvement in the final PFS
analysis in patients treated with the combination
of Imfinzi and a broad choice of five standard-of-care
platinum-based chemotherapy options vs. chemotherapy alone. The
triple combination of Imfinzi plus tremelimumab and chemotherapy also
demonstrated a statistically significant and clinically meaningful
PFS improvement vs. chemotherapy alone as a key secondary
endpoint. The safety and tolerability
of Imfinzi was consistent with its known safety
profile. The triple combination delivered a broadly similar safety
profile to the Imfinzi and chemotherapy combination and did not
result in increased discontinuation of therapy.
José Baselga, Executive Vice President, Oncology R&D,
said: "The POSEIDON trial provides evidence of the efficacy
of Imfinzi in patients with Stage IV non-small cell
lung cancer. Clinical benefit was observed in a trial population
that included a high proportion of patients with squamous disease
and multiple choices of chemotherapy regimens. Additionally, the
potential to add tremelimumab to Imfinzi and chemotherapy may present an important
treatment approach in this challenging setting, especially taking
into consideration the favourable safety
profile."
The POSEIDON trial will continue to assess the additional primary
endpoint of overall survival (OS) with data anticipated in 2020.
AstraZeneca will submit the results for presentation at a
forthcoming medical meeting and plans to share the results with
health authorities.
Imfinzi is also being
tested in Stage IV NSCLC as monotherapy in the Phase III PEARL
trial, and in earlier stages of disease as part of an extensive
Immuno-Oncology programme in lung cancer.
Imfinzi is approved in the
curative-intent setting of unresectable, Stage III NSCLC after
chemoradiation therapy in 53 countries, including the US, Japan and
across the EU, based on the Phase III PACIFIC
trial.
About POSEIDON
The POSEIDON trial is a randomised, open-label, multi-centre,
global, Phase III trial of Imfinzi plus platinum-based chemotherapy
or Imfinzi, tremelimumab and chemotherapy vs.
chemotherapy alone in the 1st-line treatment of patients
with metastatic NSCLC. The trial population included patients with
either non-squamous or squamous disease and the full range of PD-L1
expression levels. POSEIDON excluded patients with a mutation in
the epidermal growth factor receptor (EGFR) or anaplastic lymphoma
kinase (ALK) gene. In the experimental arms, patients were treated
with a flat dose of 1,500mg of Imfinzi with four cycles of chemotherapy once every
three weeks or Imfinzi plus 75mg of tremelimumab, followed by
maintenance therapy with Imfinzi or Imfinzi and one dose of tremelimumab on a
once-every-four-weeks dosing schedule. In comparison, the control
arm allowed up to six cycles of chemotherapy. Pemetrexed
maintenance therapy was allowed in all arms in patients with
non-squamous disease if given during the induction
phase.
The trial is being conducted in 153 centres across 18 countries,
including the US, Europe, South America, Asia and South Africa.
Primary endpoints include PFS and OS for
the Imfinzi plus chemotherapy arm. Key secondary
endpoints include PFS and OS in the Imfinzi plus tremelimumab and chemotherapy
arm.
About Stage IV NSCLC
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 80-85% classified
as NSCLC.2 Within
NSCLC, patients are classified as squamous, representing 25-30% of
patients, or non-squamous, the most common type representing
approximately 70-75% of NSCLC patients.2 Stage
IV is the most advanced form of lung cancer and is often referred
to as metastatic disease.3 Lung
cancer patients are most commonly diagnosed after the tumour has
spread outside of the lung.4 For
these patients with metastatic disease, prognosis is particularly
poor, as only 1 in 10 will be alive five years after
diagnosis.5
About Imfinzi
Imfinzi 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 approved for
unresectable, Stage III NSCLC in 53 countries including the US,
Japan, and across the EU, based on the Phase III PACIFIC
trial. Imfinzi is also approved for previously-treated
patients with advanced bladder cancer in 11 countries, including
the US.
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, bladder cancer, head and neck cancer, liver
cancer, biliary tract cancer, cervical cancer and other solid
tumours.
About tremelimumab
Tremelimumab is a human monoclonal antibody and potential new
medicine that targets the activity of cytotoxic
T-lymphocyte-associated protein 4 (CTLA-4). Tremelimumab blocks the
activity of CTLA-4, contributing to T cell activation and boosting
the immune response to cancer. Tremelimumab is being tested in a
clinical trial programme in combination
with Imfinzi in NSCLC, bladder cancer, head and neck
cancer, liver cancer and blood cancers.
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, lines of therapy and modes of action. 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
ADAURA, LAURA, and FLAURA2 as well as the Phase II combination
trials SAVANNAH and ORCHARD.6-8
Our extensive late-stage Immuno-Oncology programme focuses on lung
cancer patients without a targetable genetic mutation which
represents approximately three-quarters of all patients with lung
cancer.9 Imfinzi,
an anti-PDL1 antibody, is in development for patients with advanced
disease (Phase III trials POSEIDON, PEARL, and CASPIAN) and for
patients in earlier stages of disease including
potentially-curative settings (Phase III trials AEGEAN, ADJUVANT
BR.31, PACIFIC-2, PACIFIC-4, PACIFIC-5, and ADRIATIC) both as
monotherapy and in combination with tremelimumab and/or
chemotherapy.
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 radiation, chemotherapy, 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, 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.
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 and
Metabolism, and Respiratory. 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.
Media
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References
1. World Health Organization. International Agency for Research on
Cancer. Available at http://globocan.iarc.fr/Pages/fact_sheets_population.aspx.
Accessed October 2019.
2. Abernethy AP, et
al. Real-world first-line
treatment and overall survival in non-small cell lung cancer
without known EGFR mutations or ALK rearrangements in US community
oncology setting. PLoS
ONE.
2017;12(6): e0178420. https://doi.org/10.1371/journal.pone.0178420
3. Cancer.Net. Lung Cancer - Non-Small Cell: Stages. Available
at https://www.cancer.net/cancer-types/lung-cancer-non-small-cell/stages.
Accessed October 2019.
4. Ridge C, et al. Epidemiology of Lung
Cancer. Semin Intervent
Radiol.
2013;30:93-98.
5. Cancer.Net. Lung Cancer - Non-Small Cell -
Statistics." Available at www.cancer.net/cancer-types/lung-cancer-non-small-cell/statistics.
Accessed October 2019.
6. 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.
7. 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.
8. 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.
9. Pakkala, S, et al. Personalized therapy for lung cancer:
striking a moving target. JCI Insight. 2018;3(15):e120858.
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:
28 October
2019
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
|