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 May 2023
Commission File
Number: 001-11960
AstraZeneca
PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge CB2
0AA
United
Kingdom
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mark whether the registrant files or will file annual reports under
cover of Form 20-F or Form 40-F.
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20-F X
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permitted by Regulation S-T Rule 101(b)(7): ______
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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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Registrant in connection with Rule 12g3-2(b):
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AstraZeneca
PLC
INDEX
TO EXHIBITS
1.
Tagrisso plus chemo improved PFS in lung cancer
17 May
2023
Tagrisso plus
chemotherapy demonstrated strong improvement in progression-free
survival for patients with EGFR-mutated
advanced lung cancer in FLAURA2 Phase III trial
Results support potential for a new treatment option that builds
on
the benefit of first-line standard of care Tagrisso
monotherapy
Positive high-level results from the FLAURA2 Phase
III trial showed AstraZeneca's Tagrisso (osimertinib) in combination with
chemotherapy demonstrated a statistically significant and
clinically meaningful improvement in progression-free survival
(PFS) compared to Tagrisso alone for patients with locally advanced
(Stage IIIB-IIIC) or metastatic (Stage IV) epidermal growth factor
receptor-mutated (EGFRm) non-small cell lung cancer
(NSCLC).
Safety
results and discontinuation rates due to adverse events were
consistent with the established profiles of each medicine. At the
time of this analysis, the overall survival (OS) data were immature
and will be formally assessed at a subsequent
analysis.
Each year, there are an estimated 2.2 million
people diagnosed with lung cancer globally with 80-85% of patients
diagnosed with NSCLC, the most common form of lung
cancer.1-3 Approximately
70% of people are diagnosed with advanced NSCLC. Additionally,
about 10-15% of NSCLC patients in the US and Europe, and 30-40% of
patients in Asia have EGFRm NSCLC.4-6
Pasi
A. Jänne, MD, PhD, medical oncologist at Dana-Farber Cancer
Institute and principal investigator for the FLAURA2 trial, said:
"As the global standard of care for EGFR-mutated non-small cell
lung cancer, osimertinib monotherapy has transformed the treatment
landscape allowing many patients the opportunity to achieve
improved survival. FLAURA2 provides compelling evidence that the
addition of chemotherapy to osimertinib can provide a new option
for patients and clinicians that further improves outcomes compared
to osimertinib alone and as such, can further delay treatment
resistance and disease progression."
Susan Galbraith, Executive Vice President,
Oncology R&D, AstraZeneca, said: "These significant
FLAURA2 results show Tagrisso has the potential to offer patients in the
first-line setting a new treatment option that can extend the time
they live without their disease progressing. This meaningfully
builds on successive trials which have demonstrated improved
clinical benefit with Tagrisso in patients with EGFR-mutated lung
cancer."
The
data will be presented at a forthcoming medical meeting and shared
with global health authorities.
These results add to the extensive body of
evidence for Tagrisso in EGFRm NSCLC, which has improved patient
outcomes in both early-stage disease in
the ADAURA
Phase III trial and
late-stage disease in the FLAURA Phase III
trial. Tagrisso has also shown proven clinical activity in
treating central nervous system (CNS) metastases across
settings.
As part of AstraZeneca's ongoing commitment to
treating patients as early as possible in lung
cancer, Tagrisso is also being investigated in unresectable
NSCLC in the pivotal LAURA Phase III trial, with results expected
later this year.
Notes
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.1 Lung
cancer is broadly split into NSCLC and small cell lung
cancer.2 The
majority of all NSCLC patients are diagnosed with advanced
disease.7
Patients with EGFRm NSCLC are particularly
sensitive to treatment with an EGFR-tyrosine kinase inhibitor
(EGFR-TKI) which blocks the cell-signaling pathways that drive the
growth of tumour cells.8
FLAURA2
FLAURA2 is a randomised, open-label, multi-centre,
global Phase III trial in the 1st-line treatment of 586 patients
with locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV)
EGFRm NSCLC. Patients were treated with Tagrisso 80mg once daily oral tablets in combination
with chemotherapy (pemetrexed (500mg/m2) plus cisplatin (75mg/m2)
or carboplatin (AUC5)) every three weeks for four cycles, followed
by Tagrisso with pemetrexed maintenance every three
weeks.
The
trial was enrolled in more than 150 centres across more than 20
countries, including in the US, Europe, South America and Asia.
This is the final analysis of the primary endpoint of PFS. The
trial is ongoing and will continue to assess the secondary endpoint
of OS.
Tagrisso
Tagrisso (osimertinib)
is a third-generation, irreversible EGFR-TKI with proven clinical
activity in NSCLC, including against CNS metastases. AstraZeneca
continues to explore Tagrisso as a treatment for patients across multiple
stages of EGFRm NSCLC.
Tagrisso is approved as monotherapy in more than 100
countries including in the US, EU, China and Japan. These include
for 1st-line treatment of patients with locally advanced or
metastatic EGFRm NSCLC, locally advanced or metastatic EGFR T790M
mutation-positive NSCLC, and adjuvant treatment of early-stage (IB,
II and IIIA) EGFRm NSCLC, where Tagrisso recently demonstrated a statistically
significant and clinically meaningful OS
benefit.
In addition to
investigating Tagrisso and chemotherapy in late-stage disease
(FLAURA2), AstraZeneca has several ongoing Phase III trials focused
on earlier stages of lung cancer. Tagrisso is being tested in the neoadjuvant
resectable setting (NeoADAURA), in the Stage IA2-IA3 adjuvant
resectable setting (ADAURA2), and in the Stage III locally advanced
unresectable setting (LAURA).
The Company is also researching ways to address
tumour mechanisms of resistance through the SAVANNAH and ORCHARD
Phase II trials, and the SAFFRON Phase III trial, which
test Tagrisso given concomitantly with savolitinib, an
oral, potent and highly selective MET TKI, as well as other
potential new medicines.
AstraZeneca in lung
cancer
AstraZeneca
is working to bring patients with lung cancer closer to cure
through the detection and treatment of early-stage disease, while
also pushing the boundaries of science to improve outcomes in the
resistant and advanced settings. By defining new therapeutic
targets and investigating innovative approaches, the Company aims
to match medicines to the patients who can benefit
most.
The Company's comprehensive portfolio includes
leading lung cancer medicines and the next wave of innovations,
including Tagrisso (osimertinib) and Iressa (gefitinib); Imfinzi (durvalumab) and Imjudo (tremelimumab); Enhertu (trastuzumab deruxtecan) and datopotamab
deruxtecan in collaboration with Daiichi
Sankyo; Orpathys (savolitinib) in collaboration with
HUTCHMED; as well as a pipeline of potential new medicines and
combinations across diverse mechanisms of
action.
AstraZeneca
is a founding member of the Lung Ambition Alliance, a global
coalition working to accelerate innovation and deliver meaningful
improvements for people with lung cancer, including and beyond
treatment.
AstraZeneca in oncology
AstraZeneca
is leading a revolution in oncology with the ambition to provide
cures for cancer in every form, following the science to understand
cancer and all its complexities to discover, develop and deliver
life-changing medicines to patients.
The
Company's focus is on some of the most challenging cancers. It is
through persistent innovation that AstraZeneca has built one of the
most diverse portfolios and pipelines in the industry, with the
potential to catalyse changes in the practice of medicine and
transform the patient experience.
AstraZeneca
has the vision to redefine cancer care 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 in Oncology, Rare Diseases, and BioPharmaceuticals,
including 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.
World Health Organisation. International Agency for Research on
Cancer. Lung Fact Sheet. Available at:
https://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf.
Accessed May 2023.
2.
LUNGevity Foundation. Types of Lung Cancer. Available at:
https://lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer.
Accessed May 2023.
3.
Cheema
PK, et
al. Perspectives on
treatment advances for stage III locally advanced unresectable
non-small-cell lung cancer. Curr
Oncol. 2019;26(1):37-42.
4.
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.
5.
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.
6.
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.
7.
Cagle
P, et
al. Lung Cancer
Biomarkers: Present Status and Future
Developments. Archives
Pathology Lab Med. 2013;137:1191-1198.
8.
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:
17 May 2023
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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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