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 June 2024
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 plus chemo recommended for approval in EU
3 June 2024
Tagrisso with the
addition of chemotherapy recommended for approval
in
the EU by CHMP for patients with EGFR-mutated advanced lung
cancer
Recommendation based on FLAURA2 results which showed Tagrisso
plus chemotherapy extended median progression-free survival by
nearly 9 months vs. standard of care
AstraZeneca's Tagrisso (osimertinib) with the addition of
pemetrexed and platinum-based chemotherapy has been recommended for
approval in the European Union (EU) for 1st-line treatment of adult
patients with locally advanced or metastatic epidermal growth
factor receptor-mutated (EGFRm) non-small cell lung cancer
(NSCLC) whose tumours have exon 19 deletions or exon 21
(L858R) mutations.
The Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) based its positive opinion on the
results from the FLAURA2 Phase
III trial, which were also published in The
New England Journal of Medicine.
Results showed Tagrisso with the addition of chemotherapy reduced
the risk of disease progression or death by 38% compared
to Tagrisso monotherapy, which is the 1st-line global
standard of care (hazard ratio [HR] 0.62; 95% confidence interval
[CI] 0.49-0.79; p<0.0001). Median progression-free survival
(PFS) by investigator assessment was 25.5 months for patients
treated with Tagrisso plus chemotherapy, an 8.8-month improvement
versus Tagrisso monotherapy (16.7
months).
While overall survival (OS) remained immature at the second interim
analysis (41% maturity), an encouraging trend towards an OS benefit
was observed with Tagrisso plus chemotherapy
versus Tagrisso alone (HR 0.75; 95% CI 0.57-0.97). The trial
continues to assess OS as a key secondary
endpoint.
Each year in Europe, there are more than 450,000 people diagnosed
with lung cancer.1 Among
those with NSCLC, the most common form of lung cancer, about 10-15%
of patients in Europe have tumours with an EGFR
mutation.2,3 Additionally, the
majority of patients with NSCLC are diagnosed with advanced
disease.4
David Planchard, MD, PhD, thoracic oncologist at Gustave Roussy
Institute of Oncology and principal investigator for the trial,
said: "The FLAURA2 results build on the established efficacy of
osimertinib monotherapy in patients with EGFR-mutated lung cancer,
demonstrating a meaningful nine-month improvement in
progression-free survival with the addition of chemotherapy.
Today's positive recommendation is a vital step towards providing
patients in Europe with an additional treatment option capable of
extending the time before their disease progresses. This expands on
the already approved use of osimertinib as monotherapy, providing
physicians with options to tailor treatments that best suit their
patients' specific disease needs."
Susan Galbraith, Executive Vice President, Oncology R&D,
AstraZeneca, said: "Today's news reinforces the importance
of Tagrisso as the backbone therapy in EGFR-mutated lung
cancer. If approved in Europe, patients will have the option to be
treated with Tagrisso alone, or with chemotherapy, which is
especially important when caring for patients whose disease has
spread to the brain or those with L858R mutations."
The safety profile of Tagrisso plus chemotherapy was generally manageable
and consistent with the established profiles of the individual
medicines. Adverse event (AE) rates were higher in
the Tagrisso plus chemotherapy arm, driven by
well-characterised chemotherapy-related AEs. Discontinuation rates
of Tagrisso due to AEs were 11%
for Tagrisso plus
chemotherapy and 6% for monotherapy.
Tagrisso is approved as
monotherapy in more than 100 countries including in the US, EU,
China and Japan. Approved indications 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 EGFRm
NSCLC. Tagrisso with the addition of chemotherapy is also
approved in the US and several other countries for the 1st-line
treatment of patients with locally advanced or metastatic EGFRm
NSCLC.
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.5 Lung
cancer is broadly split into NSCLC and small cell lung
cancer.3 Each
year there are an estimated 2.4 million people diagnosed with lung
cancer globally, with 80-85% of patients diagnosed with NSCLC, the
most common form of lung cancer.3,5-6 The
majority of all NSCLC patients are diagnosed with advanced
disease.7
Approximately 10-15% of NSCLC patients in the US and Europe, and
30-40% of patients in Asia have EGFRm NSCLC.8-10 Patients
with EGFRm NSCLC are particularly sensitive to treatment with an
EGFR-tyrosine kinase inhibitor (EGFR-TKI) which blocks the
cell-signalling pathways that drive the growth of tumour
cells.11
FLAURA2
FLAURA2 is a randomised, open-label, multi-centre, global Phase III
trial in the 1st-line treatment of patients with locally advanced
(Stage IIIB-IIIC) or metastatic (Stage IV) EGFRm NSCLC. Patients
were treated with Tagrisso 80mg once-daily oral tablets with the
addition of 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 enrolled 557 patients in more than 150 centres across
more than 20 countries, including in the US, Europe, South America
and Asia. The primary endpoint is 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 central nervous system (CNS)
metastases. Tagrisso (40mg
and 80mg once-daily oral tablets) has been used to treat nearly
800,000 patients across its indications worldwide and AstraZeneca
continues to explore Tagrisso as
a treatment for patients across multiple stages of EGFRm
NSCLC.
There is an extensive body of evidence supporting the use
of Tagrisso in
EGFRm NSCLC. Tagrisso is
the only targeted therapy to improve patient outcomes in
early-stage disease in the ADAURA
Phase III trial, locally
advanced stages in the LAURA
Phase III trial and late-stage disease in
the FLAURA
Phase III trial and FLAURA2
Phase III trial.
As part of AstraZeneca's ongoing commitment to treating patients as
early as possible in lung cancer, Tagrisso is also being investigated in the
neoadjuvant setting in the NeoADAURA Phase III trial with results
expected later this year and in the early-stage adjuvant resectable
setting in the ADAURA2 Phase III trial.
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 plus
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 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 social media @AstraZeneca.
Contacts
For details on how to contact the Investor Relations Team, please
click here.
For Media contacts, click here.
References
1. Ferlay J, et al. Cancer incidence and mortality
patterns in Europe: Estimates for 40 countries and 25 major cancers
in 2018. Eur J
Cancer. 2018;103:356-387.
2. Sanden SV, et al. Prevalence of Epidermal Growth
Factor Receptor Exon 20 Insertion Mutations in Non-small-Cell Lung
Cancer in Europe: A Pragmatic Literature Review and
Meta-analysis. Targeted
Onc. 2022;17:153-166.
3. LUNGevity Foundation. Types of Lung Cancer.
Available at: https://lungevity.org/for-
patientscaregivers/lung-cancer-101/types-of-lung-cancer.
Accessed May 2024.
4. Cagle PT, et al. Lung Cancer
Biomarkers: Present Status and Future
Developments. Archives Pathology Lab
Med.
2013;137:1191-1198.
5. World Health Organization. International Agency
for Research on Cancer. Lung Fact Sheet. Available
at: https://gco.iarc.who.int/media/globocan/factsheets/cancers/15-trachea-bronchus-and-lung-fact-sheet.pdf. Accessed
May 2024.
6. American Cancer Society. What Is Lung Cancer?
Available at: https://www.cancer.org/cancer/lung-cancer/about/what-is.html.
Accessed May 2024.
7. Cancer.Net. Lung Cancer -
Non-Small Cell: Statistics. Available at:
https://www.cancer.net/cancer-types/lung-cancer-non-small-cell/statistics.
Accessed May 2024.
8. 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.
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;6:2800-2812.
10. 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.
11. 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:
03 June 2024
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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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AstraZeneca (NASDAQ:AZN)
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