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 December 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 approved in EU based on LAURA trial
23 December 2024
Tagrisso approved
in the EU for patients
with
unresectable EGFR-mutated lung cancer
First and only EGFR inhibitor and targeted
treatment
approved in the EU in unresectable NSCLC
Approval 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 approved 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 approval by the European Commission follows
the positive
opinion of
the Committee for Medicinal Products for Human Use and is based on
results from the LAURA Phase
III trial, which were published in The
New England Journal of Medicine.
In the trial, Tagrisso reduced the risk of disease progression or
death by 84% compared to placebo (hazard ratio 0.16; 95%
confidence interval 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, and the trial is
continuing to assess OS as a secondary endpoint.
Each year in Europe, there are more than 450,000 people diagnosed
with lung cancer, and approximately 80-85% have
NSCLC.1-3 Among
those with NSCLC in Europe, about 10-15% have tumours with
an EGFR mutation.4-6
Manuel Cobo, MD, Specialist Physician of the Medical Oncology
Service at the Carlos Haya University Hospital, Malaga, Spain, and
investigator for the trial, said: "Today's approval marks a major
breakthrough for patients in the EU with
unresectable, EGFR-mutated non-small cell lung cancer, delivering
the first targeted treatment in this setting. Osimertinib reduced
the risk of disease progression or death by an unprecedented 84 per
cent in the LAURA trial, setting a new benchmark for outcomes and
underscoring the importance of testing for EGFR mutations upon
diagnosis."
Dave Fredrickson, Executive Vice President, Oncology Business Unit,
AstraZeneca, said: "Tagrisso is
now the first and only EGFR inhibitor and
targeted treatment approved
in the EU for locally
advanced, unresectable lung cancer, providing a new standard of
care to patients who have historically experienced early
progression after chemoradiation
therapy. The powerful results from the LAURA trial
show Tagrisso improves outcomes for patients in the
unresectable setting, reinforces the importance of timely EGFR
testing and solidifies Tagrisso as the backbone therapy
in EGFR-mutated non-small cell lung
cancer."
The safety and tolerability of Tagrisso in the LAURA trial was consistent with its
established profile and no new safety concerns were
identified.
This is the fifth major approval for Tagrisso based
on the LAURA trial following recent approvals in
the US, Switzerland, South Korea and Australia. Regulatory
applications are also currently under review in China, Japan and
several other countries.
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.7 Lung
cancer is the leading cause of cancer death among both men and
women, accounting for about one-fifth of all cancer
deaths.7 Lung
cancer is broadly split into NSCLC and small cell lung cancer, with
80-85% of patients diagnosed with NSCLC, the most common form of
lung cancer.2,3 The
majority of all NSCLC patients are diagnosed with advanced
disease.8
Approximately 10-15% of NSCLC patients in the US and Europe,
and 30-40% of patients in Asia have EGFRm NSCLC.4-6 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.9
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
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.
American Cancer Society. What Is Lung Cancer? Available at:
https://www.cancer.org/cancer/types/lung-cancer/about/what-is.html.
Accessed December 2024.
3.
LUNGevity Foundation. Types of Lung Cancer. Available at:
https://lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer.
Accessed December 2024.
4. 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;29:2121-2127.
5. 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.
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.
World Health Organization. International Agency for Research on
Cancer. Lung Cancer Fact Sheet. Available at:
https://gco.iarc.who.int/media/globocan/factsheets/cancers/15-trachea-bronchus-and-lung-fact-sheet.pdf.
Accessed December 2024.
8. González M, et al. Overall
survival for early and locally advanced non-small-cell lung cancer
from one institution: 2000-2017. Clin Transl
Oncol.
2021;23(7):1325-1333.
9. 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.
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AstraZeneca
PLC
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Date:
23 December 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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