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 2020
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
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as permitted by Regulation S-T Rule 101(b)(7): ______
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by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information
to the Commission pursuant to Rule 12g3-2(b) under the Securities
Exchange Act of 1934.
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assigned to the Registrant in connection with Rule 12g3-2(b):
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Tagrisso
adjuvant lung cancer US Priority Review
20 October 2020 07:00 BST
Tagrisso granted Priority Review in the US for the
adjuvant
treatment of patients with early-stage EGFR-mutated lung
cancer
Unprecedented results show treatment with Tagrisso reduced the
risk
of disease recurrence or death by 80% in ADAURA Phase III
trial
AstraZeneca's Tagrisso (osimertinib) has received acceptance for
its supplemental New Drug Application (sNDA) and has also been
granted Priority Review in the US for the adjuvant treatment of
patients with early-stage (IB, II and IIIA) epidermal growth factor
receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after
complete tumour resection with curative intent.
While up to 30% of all patients with NSCLC may be diagnosed early
enough to have potentially curative surgery, disease recurrence is
still common in early-stage disease and nearly half of patients
diagnosed in Stage IB, and over three quarters of patients
diagnosed in Stage IIIA, experience recurrence within five
years.1-4
The Food and Drug Administration (FDA) grants Priority Review to
applications for medicines that offer significant
improvements over available options by demonstrating safety or
efficacy improvements, preventing serious conditions, or enhancing
patient compliance. The
Prescription Drug User Fee Act date, the FDA action date for their
regulatory decision, is during the first quarter of
2021.
Dave Fredrickson, Executive Vice President, Oncology Business Unit,
said: "Patients with early-stage EGFR-mutated lung cancer are
still at considerable risk of recurrence after surgery and adjuvant
chemotherapy, and new targeted treatment options are critical to
improving outcomes for these patients. This expedited review
underscores the unprecedented disease-free survival
benefit Tagrisso brings to patients in the adjuvant setting,
and we will continue working with the FDA to provide this
practice-changing treatment to patients as quickly as
possible."
The sNDA was based on results from the ADAURA Phase III trial
showing Tagrisso demonstrated a statistically significant and
clinically meaningful improvement in disease-free survival (DFS) in
the primary analysis population of patients with Stage II and IIIA
EGFRm NSCLC, and also in the overall trial population of patients
with Stage IB-IIIA disease, a key secondary
endpoint.
In April
2020, an Independent Data Monitoring Committee
recommended for the trial to be unblinded two years early, based on
its determination of overwhelming efficacy. Investigators and
patients continue to participate in the trial and remain blinded to
treatment. The results from the ADAURA trial were presented during
the plenary session of the American Society of Clinical Oncology
ASCO20 Virtual Scientific Program in May
2020 and were recently
published in The
New England Journal of Medicine.
Tagrisso received
Breakthrough Therapy Designation in this setting
in July
2020. Tagrisso is approved for both the 1st-line treatment
of patients with locally advanced or metastatic EGFRm NSCLC and for
the treatment of locally advanced or metastatic EGFR T790M
mutation-positive NSCLC in the US, Japan, China, the EU and many
other countries around the world.
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.5 Lung
cancer is broadly split into NSCLC and small cell lung cancer, with
80-85% classified as NSCLC.6 The
majority of all NSCLC patients are diagnosed with advanced disease
while approximately 25-30% present with resectable disease at
diagnosis.1-3
For those with resectable tumours, the majority of patients
eventually develop recurrence despite complete tumour resection and
adjuvant chemotherapy.4 Early-stage
lung cancer diagnoses are often only made when the cancer is found
on imaging for an unrelated condition.7-8
Approximately 10-15% of NSCLC patients in the US and Europe, and
30-40% of patients in Asia have EGFRm NSCLC.9-11 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.12
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 following complete tumour resection
and adjuvant chemotherapy as indicated. Patients were treated
with Tagrisso 80mg once-daily oral tablets or placebo 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 in Stage II and IIIA
patients and a key secondary endpoint is DFS in Stage IB, II and
IIIA patients. The data readout was originally anticipated in 2022.
The trial will continue to assess overall survival.
Tagrisso
Tagrisso (osimertinib) is
a third-generation, irreversible EGFR-TKI with clinical activity
against central nervous system metastases. Tagrisso 40mg and 80mg once-daily oral tablets have
received approval in the US, Japan, China, the EU and many
countries around the world for 1st-line EGFRm advanced NSCLC and
EGFR T790M mutation-positive advanced NSCLC.
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.
AstraZeneca aims to address the unmet needs of patients with EGFRm
tumours as a genetic driver of disease with the approved
medicines Iressa (gefitinib) and Tagrisso and its ongoing LAURA, NeoADAURA and FLAURA2
Phase III trials.
AstraZeneca is committed to addressing tumour mechanisms of
resistance through the ongoing SAVANNAH and ORCHARD Phase II
trials, which test Tagrisso in combination with savolitinib, a selective
inhibitor of c-MET receptor tyrosine kinase, along with other
potential new medicines.
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. Cagle P, et al. Lung Cancer Biomarkers: Present Status and
Future Developments. Archives Pathology Lab
Med. 2013;137:1191-1198.
2. Le Chevalier T. Adjuvant Chemotherapy for Resectable
Non-Small-Cell Lung Cancer: Where is it
Going? Ann Oncol. 2010;21:196-8.
3. Datta D, et al. Preoperative Evaluation of Patients
Undergoing Lung Resection Surgery. Chest. 2003;123: 2096-2103.
4. Pignon et al. Lung Adjuvant Cisplatin Evaluation: A Pooled
Analysis by the LACE Collaborative Group. J Clin
Oncol 2008;26:3552-3559.
5. World Health Organization. International Agency for Research on
Cancer. Lung Fact Sheet. Available at http://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf.
Accessed August 2020.
6. LUNGevity Foundation. Types of Lung Cancer. Available
at https://www.lungevity.org/about-lung-cancer/lung-cancer-101/types-of-lung-cancer.
Accessed August 2020.
7. Sethi S, et al. Incidental Nodule Management - Should There
Be a Formal Process?. Journal of Thorac Onc.
2016:8;S494-S497.
8. LUNGevity Foundation. Screening and Early Detection. Available
at: https://lungevity.org/for-patients-caregivers/lung-cancer-101/screening-early-detection#1.
Accessed August 2020.
9. 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.
10. 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.
11. 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.
12. Cross DA, et al. AZD9291, an Irreversible EGFR TKI, Overcomes
T790M-Mediated Resistance to EGFR Inhibitors in Lung
Cancer. Cancer
Discov.
2014;4(9):1046-1061.
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:
20 October 2020
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
|
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