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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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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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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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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