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 November 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 recommended for EU approval - LAURA
18 November 2024
Tagrisso recommended
for approval in the EU by CHMP
for patients with
unresectable EGFR-mutated lung cancer
Recommendation based on LAURA Phase III trial results which
showed Tagrisso extended median progression-free survival to more
than three years
AstraZeneca's Tagrisso (osimertinib) has been recommended for
approval in the European Union (EU) for the treatment of adult
patients with locally advanced, unresectable non-small cell lung
cancer (NSCLC) whose tumours have epidermal growth factor receptor
(EGFR) exon 19 deletions or exon 21 (L858R)
substitution mutations and whose disease has not progressed during
or following platinum-based chemoradiation therapy
(CRT).
The Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) based its positive opinion on the
results from the LAURA Phase
III trial, which were published in The
New England Journal of Medicine.
Results showed Tagrisso reduced the risk of disease progression or
death by 84% compared to placebo (hazard ratio [HR] 0.16; 95%
confidence interval [CI] 0.10-0.24; p<0.001) as assessed by
blinded independent central review. Median progression-free
survival (PFS) was 39.1 months in patients treated
with Tagrisso versus 5.6 months for
placebo.
Overall survival (OS) results remain immature at this current
analysis. The trial continues to assess OS as a 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,
nearly one in five people with NSCLC has an unresectable
tumour.4
Manuel Cobo, MD, Specialist Physician of the Medical Oncology
Service at the Carlos Haya University Hospital, Malaga, Spain, and
investigator for the trial, said: "The LAURA results build on the
established efficacy of osimertinib and support the approval of the
first targeted therapy for patients with
unresectable, EGFR-mutated lung cancer. Today's positive
recommendation marks an important step towards offering patients in
Europe a targeted treatment option that can extend the time before
their disease progresses by more than three
years."
Susan Galbraith, Executive Vice President, Oncology R&D,
AstraZeneca, said: "Today's news
reinforces Tagrisso as
the backbone therapy in EGFR-mutated non-small cell lung cancer, meeting the
critical unmet need for an effective targeted treatment option in
the unresectable setting. Tagrisso has now demonstrated its benefit across all
stages of EGFR-mutated lung cancer, representing a pivotal step
in transforming care for patients who are urgently in need of
innovative therapies that can help extend their lives."
The safety and tolerability of Tagrisso in the LAURA trial was consistent with its
established profile and no new safety concerns were
identified.
Tagrisso following CRT was
recently approved for the treatment of adult patients with
unresectable, Stage III EGFRm NSCLC in the US. Regulatory
applications are also currently under review in China, Japan and
several other countries based on the LAURA
trial.
Tagrisso is approved as
monotherapy in more than 100 countries including in the US, EU,
China and Japan. Approved indications include 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 is also approved in combination with
chemotherapy in the US, China and several other countries for
1st-line treatment of patients with locally advanced or metastatic
EGFRm NSCLC.
Notes
Lung cancer
Each year, an estimated 2.4 million people are diagnosed with lung
cancer globally.5 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 The
majority of all NSCLC patients are diagnosed with advanced
disease.6
Approximately 10-15% of NSCLC patients in the US and Europe, and
30-40% of patients in Asia have EGFRm NSCLC.7-9 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.10
LAURA
LAURA is a randomised, double-blind, placebo-controlled,
multi-centre, global Phase III trial in patients with unresectable,
Stage III EGFRm NSCLC whose disease has not progressed
following definitive platinum-based CRT. Patients were treated
with Tagrisso 80mg once-daily oral tablets until disease
progression, unacceptable toxicity or other discontinuation
criteria were met. Upon progression, patients in the placebo arm
were offered treatment with Tagrisso.
The trial enrolled 216 patients in more than 145 centres across
more than 15 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 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 as
standard of care in EGFRm NSCLC. Tagrisso improved
patient outcomes in early-stage disease in the ADAURA
Phase III trial, Stage
III, unresectable disease in the LAURA
Phase III trial, late-stage
disease in the FLAURA
Phase III trial, and with chemotherapy in
the 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 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 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's innovative
medicines are sold in more than 125 countries and 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://www.lungevity.org/lung-cancer-basics/types-of-lung-cancer.
Accessed November 2024.
4.
Quint LE. Lung cancer: assessing
resectability. Cancer
Imaging. 2004;4(1):15-18.
5.
World Health Organization. International Agency
for Research on Cancer. All Cancers Fact Sheet. Available
at: https://gco.iarc.who.int/media/globocan/factsheets/cancers/39-all-cancers-fact-sheet.pdf. Accessed
November 2024.
6.
Cagle P, et al. Lung Cancer Biomarkers: Present
Status and Future Developments. Arch Pathol Lab
Med.
2013;137(9):1191-1198.
7.
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(15):2121-2127.
8.
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(12):
2800-2812.
9.
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(2):79-89.
10.
Cross DAE, 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.
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AstraZeneca
PLC
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Date:
18 November 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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