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 April 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.
Tagrisso Phase III
ADAURA trial will be unblinded early after overwhelming efficacy in
the adjuvant treatment of patients with EGFR-mutated lung
cancer
This announcement contains inside information
10 April 2020 18:00 BST
Tagrisso Phase III ADAURA trial will be unblinded
early after overwhelming efficacy in the adjuvant treatment of
patients with EGFR-mutated lung cancer
ADAURA is the first global trial for an EGFR inhibitor to show
statistically
significant and clinically meaningful benefit in adjuvant treatment
of lung cancer
Plans for regulatory submission already underway
The ADAURA Phase III trial
for Tagrisso (osimertinib) in the adjuvant treatment of
patients with Stage IB, II and IIIA epidermal growth factor
receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) with
complete tumour resection will be unblinded early following a
recommendation from an Independent Data Monitoring Committee (IDMC)
based on its determination of overwhelming
efficacy.
José
Baselga, Executive Vice President, Oncology R&D, said: "We are
thrilled by the recommendation to unblind the Phase III ADAURA
trial much earlier than expected and are incredibly excited with
these unprecedented results in patients with early-stage
EGFR-mutated non-small cell lung cancer. Lung cancer is a
devastating diagnosis and for the first time an EGFR-targeted
medicine can now provide the hope of cure."
The primary endpoint of the Phase III ADAURA trial is disease-free
survival (DFS). Tagrisso was assessed against placebo for a treatment
duration of up to three years. The trial will continue to assess
the secondary endpoint of overall survival. In its communication to
AstraZeneca, the IDMC did not raise any new safety
concerns. The data will be presented at a forthcoming medical
meeting.
Lung cancer
Lung cancer is the leading cause of cancer death among both men and
women, accounting for about one-fifth of all cancer deaths, more
than breast, prostate and colorectal cancers
combined.1 Lung
cancer is broadly split into NSCLC and small cell lung cancer, with
80-85% classified as NSCLC.2 Approximately
10-15% of NSCLC patients in the US and Europe, and 30-40% of
patients in Asia have EGFRm NSCLC.3,4,5 These
patients are particularly sensitive to treatment with EGFR-tyrosine
kinase inhibitors (TKIs) which block the cell-signalling pathways
that drive the growth of tumour cells. Based on AstraZeneca
estimates, just over 60% of NSCLC patients are diagnosed with
early-stage (Stage I-III) disease.
ADAURA
ADAURA is a randomised, double-blinded, global, placebo-controlled
Phase III trial in the adjuvant treatment of 682 patients with
Stage IB, II, IIIA EGFRm NSCLC with complete tumour resection and
optional, standard post-operative adjuvant chemotherapy. In the
experimental arm, patients were treated
with Tagrisso 80mg once-daily oral tablets for three years
or until disease recurrence. The trial enrolled in more than 200
centres across more than 20 countries, including the US, in Europe,
South America, Asia and the Middle East. The primary endpoint is
DFS; data readout was originally anticipated in
2022.
Tagrisso
Tagrisso (osimertinib) is
a third-generation, irreversible EGFR-TKI designed to inhibit both
EGFR-sensitising and EGFR T790M-resistance mutations, with clinical
activity against CNS metastases. Tagrisso 40mg and 80mg once-daily oral tablets have
now received approval in 80 countries, including the US, Japan,
China and the EU, for 1st-line EGFRm advanced NSCLC, and in 87
countries, including the US, Japan, China and the EU, for 2nd-line
use in patients with EGFR T790M mutation-positive advanced
NSCLC. Tagrisso is also being developed in the locally
advanced unresectable setting (LAURA), in combination with
chemotherapy (FLAURA2) in the metastatic setting, and with
potential new medicines to address resistance to EGFR-TKIs
(SAVANNAH, ORCHARD).
AstraZeneca in lung cancer
AstraZeneca has a comprehensive portfolio of approved and potential
new medicines in late-stage development for the treatment of
different forms of lung cancer spanning different histologies,
several stages of disease, lines of therapy and modes of action. We
aim to address the unmet needs of patients with EGFRm 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 the
approved medicines Iressa (gefitinib) and Tagrisso, and its ongoing Phase III trials ADAURA, LAURA,
and FLAURA2.3,6-7
We are also committed to addressing tumour mechanisms of resistance
through the ongoing Phase II trials SAVANNAH and ORCHARD which
test Tagrisso in combination with savolitinib, a selective
inhibitor of c-MET receptor tyrosine kinase, along with other
potential new medicines. Enhertu (trastuzumab deruxtecan), a HER2-directed
antibody drug conjugate is in development for metastatic
non-squamous HER2-overexpressing or HER2-mutated NSCLC including
trials in combination with other anticancer
treatments.
An extensive late-stage Immuno-Oncology programme focuses on lung
cancer patients without a targetable genetic mutation which
represents up to three-quarters of all patients with lung
cancer.8 Imfinzi,
an anti-PDL1 antibody, is in development for patients with advanced
disease (Phase III trials POSEIDON and PEARL) 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. Imfinzi is also in development in the Phase II
combination trials NeoCOAST, COAST and HUDSON in combination with
potential new medicines from the early-stage
pipeline.
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.
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.
World
Health Organization. International Agency for Research on Cancer.
Globocan Worldwide Fact Sheet 2018. Available at
http://globocan.iarc.fr/Pages/fact_sheets_population.aspx.
2.
LUNGevity
Foundation. Types of Lung Cancer. Available at
https://www.lungevity.org/about-lung-cancer/lung-cancer-101/types-of-lung-cancer.
3.
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.
4.
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.
5.
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.
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.
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.
8.
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:
14 April 2020
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By: /s/
Adrian Kemp
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|
Name:
Adrian Kemp
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|
Title:
Company Secretary
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