TIDMAZN
RNS Number : 4182V
AstraZeneca PLC
14 April 2021
14 April 2021 07:00 BST
Tagrisso approved in China for the adjuvant treatment
of patients with early-stage EGFR-mutated lung cancer
Tagrisso is the only targeted medicine to show efficacy in the
treatment of early-stage lung cancer in a global trial and the
first such medicine approved in China
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 China
for the adjuvant treatment of patients with early-stage (IB, II and
IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small
cell lung cancer (NSCLC) after tumour resection with curative
intent, with or without adjuvant chemotherapy as recommended by the
patient's physician. Tagrisso is indicated for EGFRm patients whose
tumours have exon 19 deletions or exon 21 (L858R) mutations.
The approval by China's National Medical Products Administration
(NMPA) was based on positive results from the ADAURA Phase III
trial. In the trial, 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 ADAURA trial also showed a
statistically significant and clinically meaningful improvement in
DFS in the overall trial population of patients with Stage IB-IIIA
disease, 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 recurrence within five
years.(1-3) More than a third of the world's lung cancer patients
are in China and among those with NSCLC, approximately 40% have
tumours with an EGFR mutation.(4-6)
Dave Fredrickson, Executive Vice President, Oncology Business
Unit, said: "The expedited approval of Tagrisso in China as part of
a curative-intent regimen for early-stage EGFR-mutated lung cancer
underscores the high unmet need in this setting and our commitment
to improving outcomes in a country with one of the highest rates of
EGFR mutations in the world. This approval reinforces the
importance of EGFR testing across all stages of lung cancer, prior
to treatment decisions, to ensure as many patients as possible can
benefit from targeted therapies like Tagrisso and 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, including
in Asian and non-Asian patients. 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 approved to treat early-stage lung cancer in more
than a dozen countries, including the US, 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 China, and in the US, Japan,
the EU and many other countries.
This approval follows a priority review designation by the
NMPA's Center for Drug Evaluation. It marks the third approved
indication for Tagrisso in China following previous approvals in
2nd-line T790M and 1st-line EGFRm NSCLC, which are both included on
the National Reimbursement Drug List.
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.(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. Investigators 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 approximately 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 Stage III
locally advanced unresectable setting (LAURA), in the neoadjuvant
resectable setting (NeoADAURA) and in combination with chemotherapy
(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 has a comprehensive portfolio of approved and
potential new medicines in late-stage development for the treatment
of different forms of lung cancer spanning different histologies,
stages of disease, lines of therapy and modes of action. These
medicines include Tagrisso, Imfinzi (durvalumab), Enhertu
(trastuzumab deruxtecan), datopotamab deruxtecan and
savolitinib.
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,
primarily for the treatment of diseases in three therapy areas -
Oncology, 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. Archives Pathology Lab Med.
2013;137:1191-1198.
2. Le Chevalier T. Adjuvant Chemotherapy for Resectable
Non-Small-Cell Lung Cancer: Where is it Going? Ann Oncol.
2010;21:196-8.
3. Pignon 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 April 2021.
5. World Health Organization. International Agency for Research
on Cancer. Globocan China Fact Sheet 2020. Available at
http://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf.
Accessed April 2021.
6. Zhang, Y.L., 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): 78985-78993.
7. LUNGevity Foundation. Types of Lung Cancer. Available at
https://lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer.
Accessed April 2021.
8. Sethi S, et al. Incidental Nodule Management - Should There
Be a Formal Process?. Journal of Thorac Onc. 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 April 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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