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 February 2024
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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to the Commission pursuant to Rule 12g3-2(b) under the Securities
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Tagrisso improved PFS in Stage III lung cancer
19 February 2024
Tagrisso demonstrated
overwhelming efficacy benefit for patients with
unresectable, Stage III EGFR-mutated lung cancer in LAURA Phase III
trial
First EGFR inhibitor and targeted treatment to
demonstrate
progression-free survival benefit in Stage
III setting
Positive high-level results from the LAURA Phase III trial showed
AstraZeneca's Tagrisso (osimertinib) demonstrated a statistically
significant and highly clinically meaningful improvement in
progression-free survival (PFS) for patients with unresectable,
Stage III epidermal growth factor receptor-mutated (EGFRm)
non-small cell lung cancer (NSCLC) after chemoradiotherapy
(CRT) compared to placebo after CRT.
Overall survival (OS) data showed a favourable trend
for Tagrisso, although data were not mature at the time of
this analysis. The trial will continue to assess OS as a secondary
endpoint.
Each year an estimated 2.4 million people are diagnosed with lung
cancer globally with 80-85% of patients diagnosed with NSCLC, the
most common form of lung cancer.1-3 Approximately
10-15% of NSCLC patients in the US and Europe, and 30-40% of
patients in Asia, have EGFR mutations.4-7 More
than one in six patients with NSCLC are diagnosed with unresectable
Stage III disease (15%).8
Suresh Ramalingam, MD, Executive Director of Winship Cancer
Institute of Emory University, Atlanta, US, and principal
investigator in the trial, said: "These results represent a major
advance for patients with Stage III EGFR-mutated lung cancer who
have a high propensity for early progression and spread to the
brain, and where no targeted therapy is available. LAURA shows
osimertinib can provide impactful clinical benefit and could become
the first targeted treatment option for patients with Stage III
disease."
Susan Galbraith, Executive Vice President, Oncology R&D,
AstraZeneca, said: "These highly impactful results for the LAURA
trial in this potentially curative early lung cancer setting
further entrench Tagrisso as the backbone therapy for EGFR-mutated
lung cancer. These data together with the ADAURA data, reinforce
the imperative to diagnose and treat patients with lung cancer as
early as possible."
The safety and tolerability of Tagrisso in the LAURA trial was consistent with its
established profile and no new safety concerns were reported
with Tagrisso maintenance treatment following
CRT.
The data will be presented at a forthcoming medical meeting and
shared with global regulatory authorities.
In addition, Tagrisso plus chemotherapy was recently approved in
the US based on 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 with results
expected later this year, and in the early-stage adjuvant
resectable setting in the ADAURA2 Phase III
trial.
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.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.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 permitted to be treated 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. This is the 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 central nervous system
metastases. Tagrisso (40mg
and 80mg once-daily oral tablets) has been used to treat more than
800,000 patients across its indications worldwide and 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.
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 both
early-stage disease in the ADAURA
Phase III trial and late-stage disease in
the FLAURA
Phase III trial and FLAURA2
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. World Health Organisation.
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 February 2024.
2. LUNGevity Foundation. Types of Lung
Cancer. Available at: https://lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer.
Accessed February 2024.
3. American Cancer Society. What Is
Lung Cancer? Available at: https://www.cancer.org/cancer/lung-cancer/about/what-is.html#:~:text=About%2080%25%20to%2085%25%20of,(outlook)%20are%20often%20similar.
Accessed February 2024.
4.
Knight SB, et al. Progress and prospects of early detection in lung
cancer. Open Biol. 2017;7(9): 170070.
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.
Zhang Y, et al. The prevalence of EGFR mutation in patients with
non-small cell lung cancer: a systematic review and meta-analysis.
Oncotarget. 2016;7(48).
7.
Szumera-Ciećkiewicz A, et al. EGFR Mutation Testing on
Cytological and Histological Samples in 11. 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.
8.
Cerner CancerMPact database.Accessed October 2023.
9. 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.
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:
19 February 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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