TIDMAZN
RNS Number : 1174A
AstraZeneca PLC
28 May 2021
28 May 2021 07:00 BST
Tagrisso approved in the EU for the adjuvant treatment
of patients with early-stage EGFR-mutated lung cancer
Approval based on unprecedented results from the ADAURA Phase
III trial
where Tagrisso reduced the risk of disease recurrence or death
by 80%
AstraZeneca's Tagrisso (osimertinib) has been approved in the
European Union (EU) for the adjuvant treatment of adult patients
with early-stage (IB, II and IIIA) epidermal growth factor
receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after
complete tumour resection with curative intent. Tagrisso is
indicated for EGFRm patients whose tumours have exon 19 deletions
or exon 21 (L858R) mutations.
The approval by the European Commission was based on positive
results from the ADAURA Phase III trial in which Tagrisso
demonstrated a statistically significant and clinically meaningful
improvement in disease-free survival (DFS) in the primary analysis
population of patients with Stage II and IIIA EGFRm NSCLC. The
trial also showed a statistically significant and clinically
meaningful improvement in DFS for Tagrisso in the overall trial
population, a key secondary endpoint.
While up to 30% of all patients with NSCLC may be diagnosed
early enough to have surgery with curative intent, recurrence is
still common in early-stage disease. Historically, nearly half of
patients diagnosed in Stage IB, and over three quarters of patients
diagnosed in Stage IIIA, have experienced disease recurrence within
five years.(1-3) About a fifth of the world's lung cancer patients
are in the EU and among those with NSCLC, approximately 15% have
tumours with an EGFR mutation.(4-6)
Margarita Majem, MD, PhD, Department of Medical Oncology,
Hospital de la Santa Creu i Sant Pau, Spain, said: "In the early
stages of lung cancer, where tumour resection is possible but
recurrence is far too common, adjuvant Tagrisso has shown an
unprecedented disease-free survival benefit for patients with EGFR
mutations. I expect this approval will change clinical practice in
the EU, as it heightens the critical importance of EGFR mutation
testing across all stages of lung cancer to ensure as many patients
as possible can benefit from targeted medicines like Tagrisso."
Dave Fredrickson, Executive Vice President, Oncology Business
Unit, said: "We know the earlier a patient's cancer is detected and
treated, the greater chance they may have of being cured, which is
why this approval is significant. For the first time, patients in
the EU with EGFR-mutated lung cancer have a targeted,
biomarker-driven treatment option available in the early stages of
their disease that can help them live cancer-free longer."
In the ADAURA trial, adjuvant treatment with Tagrisso reduced
the risk of disease recurrence or death by 83% in patients with
Stage II and IIIA disease (hazard ratio [HR] 0.17; 99.06%
confidence interval [CI] 0.11-0.26; p<0.001) and by 80% in the
overall trial population of patients with Stage IB-IIIA disease (HR
0.20; 99.12% CI 0.14-0.30; p<0.001).
Consistent DFS results were seen regardless of prior adjuvant
chemotherapy use and across all prespecified subgroups. The safety
and tolerability of Tagrisso in this trial was consistent with
previous trials in the metastatic setting. The ADAURA results were
published in The New England Journal of Medicine .
Tagrisso is now approved to treat early-stage lung cancer in
more than fifty countries, including in the US and China , and
additional global regulatory reviews are ongoing. Tagrisso is also
approved for the 1st-line treatment of patients with locally
advanced or metastatic EGFRm NSCLC and for the treatment of locally
advanced or metastatic EGFR T790M mutation-positive NSCLC in the
EU, the US, Japan, China and many other countries.
Lung cancer
Lung cancer is the leading cause of cancer death among men and
women, accounting for about one-fifth of all cancer deaths.(4) Lung
cancer is broadly split into NSCLC and small cell lung cancer, with
80-85% classified as NSCLC.(7) The majority of NSCLC patients are
diagnosed with advanced disease while approximately 25-30% present
with resectable disease at diagnosis.(1-2) Early-stage lung cancer
diagnoses are often only made when the cancer is found on imaging
for an unrelated condition.(8-9)
For patients with resectable tumours, the majority of patients
eventually develop recurrence despite complete tumour resection and
adjuvant chemotherapy.(3)
Approximately 10-15% of NSCLC patients in the US and Europe, and
30-40% of patients in Asia have EGFRm NSCLC.(10-12) These patients
are particularly sensitive to treatment with an EGFR-tyrosine
kinase inhibitor (TKI) which blocks the cell-signalling pathways
that drive the growth of tumour cells.(13)
ADAURA
ADAURA is a randomised, double-blind, global, placebo-controlled
Phase III trial in the adjuvant treatment of 682 patients with
Stage IB, II and IIIA EGFRm NSCLC following complete tumour
resection and adjuvant chemotherapy as indicated. Patients were
treated with Tagrisso 80mg once-daily oral tablets or placebo for
three years or until disease recurrence.
The trial enrolled patients in more than 200 centres across more
than 20 countries, including the US, in Europe, South America, Asia
and the Middle East. The primary endpoint was DFS in Stage II and
IIIA patients and a key secondary endpoint was DFS in Stage IB, II
and IIIA patients.
The data readout was originally anticipated in 2022. In April
2020, an Independent Data Monitoring Committee recommended for the
trial to be unblinded two years early based on a determination of
overwhelming efficacy. Treating physicians and patients continue to
participate and remain blinded to treatment. The trial will
continue to assess overall survival.
Tagrisso
Tagrisso (osimertinib) is a third-generation, irreversible EGFR
TKI with clinical activity against central nervous system
metastases. Tagrisso (40mg and 80mg once-daily oral tablets) has
been used to treat more than 250,000 patients across indications
worldwide and AstraZeneca continues to explore Tagrisso as a
treatment for patients across multiple stages of EGFRm NSCLC.
In Phase III trials, Tagrisso is being tested in the neoadjuvant
resectable setting (NeoADAURA), in the Stage III locally advanced
unresectable setting (LAURA) and, in combination with chemotherapy,
in the Stage III locally advanced or Stage IV metastatic settings
(FLAURA2). AstraZeneca is also researching ways to address tumour
mechanisms of resistance through the SAVANNAH and ORCHARD Phase II
trials, 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 tremelimumab; Enhertu (trastuzumab deruxtecan) and datopotamab
deruxtecan in collaboration with Daiichi Sankyo; 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 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
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References
1. Cagle P, et al. Lung Cancer Biomarkers: Present Status and
Future Developments. Arch Pathol Lab Med. 2013;137:1191-1198.
2. Le Chevalier T, et al. Adjuvant Chemotherapy for Resectable
Non-Small Cell Lung Cancer: Where is it Going? Ann Oncol.
2010;21:vii196-vii198.
3. Pignon J, et al. Lung Adjuvant Cisplatin Evaluation: A Pooled
Analysis by the LACE Collaborative Group. J Clin Oncol.
2008;26:3552-3559.
4. World Health Organization. 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 2021.
5. World Health Organization. International Agency for Research
on Cancer. Globocan United Kingdom Fact Sheet 2020. Available at
https://gco.iarc.fr/today/data/factsheets/populations/826-united-kingdom-fact-sheets.pdf.
Accessed May 2021.
6. Midha A, et al. EGFR mutation incidence in non-small cell
lung cancer of adenocarcinoma histology: a systematic review and
global map by ethnicity (mutMapII). Am J Cancer Res.
2015;5(9):2892-2911.
7. LUNGevity Foundation. Types of Lung Cancer. Available at
https://lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer.
Accessed May 2021.
8. Sethi S, et al. Incidental Nodule Management - Should There
Be a Formal Process?. J Thorac Dis. 2016:8;S494-S497.
9. LUNGevity Foundation. Screening and Early Detection.
Available at
https://lungevity.org/for-patients-caregivers/lung-cancer-101/screening-early-detection.
Accessed May 2021.
10. 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.
11. Keedy V.L., 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.
12. 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.
13. 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
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