TIDMAZN
RNS Number : 6215C
AstraZeneca PLC
20 October 2020
20 October 2020 07:00 BST
Tagrisso granted Priority Review in the US for the adjuvant
treatment of patients with early-stage EGFR-mutated lung
cancer
Unprecedented results show treatment with Tagrisso reduced the
risk
of disease recurrence or death by 80% in ADAURA Phase III
trial
AstraZeneca's Tagrisso (osimertinib) has received acceptance for
its supplemental New Drug Application (sNDA) and has also been
granted Priority Review in the US 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
complete tumour resection with curative intent.
While up to 30% of all patients with NSCLC may be diagnosed
early enough to have potentially curative surgery, disease
recurrence is still common in early-stage disease and nearly half
of patients diagnosed in Stage IB, and over three quarters of
patients diagnosed in Stage IIIA, experience recurrence within five
years.(1-4)
The Food and Drug Administration (FDA) grants Priority Review to
applications for medicines that offer significant improvements over
available options by demonstrating safety or efficacy improvements,
preventing serious conditions, or enhancing patient compliance. The
Prescription Drug User Fee Act date, the FDA action date for their
regulatory decision, is during the first quarter of 2021.
Dave Fredrickson, Executive Vice President, Oncology Business
Unit, said: "Patients with early-stage EGFR-mutated lung cancer are
still at considerable risk of recurrence after surgery and adjuvant
chemotherapy, and new targeted treatment options are critical to
improving outcomes for these patients. This expedited review
underscores the unprecedented disease-free survival benefit
Tagrisso brings to patients in the adjuvant setting, and we will
continue working with the FDA to provide this practice-changing
treatment to patients as quickly as possible."
The sNDA was based on results from the ADAURA Phase III trial
showing 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, and also in the overall trial population of patients
with Stage IB-IIIA disease, a key secondary endpoint.
In April 2020 , an Independent Data Monitoring Committee
recommended for the trial to be unblinded two years early, based on
its determination of overwhelming efficacy. Investigators and
patients continue to participate in the trial and remain blinded to
treatment. The results from the ADAURA trial were presented during
the plenary session of the American Society of Clinical Oncology
ASCO20 Virtual Scientific Program in May 2020 and were recently
published in The New England Journal of Medicine .
Tagrisso received Breakthrough Therapy Designation in this
setting in July 2020. Tagrisso is approved for both 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 US, Japan, China, the EU and
many other countries around the world.
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.(5)
Lung cancer is broadly split into NSCLC and small cell lung cancer,
with 80-85% classified as NSCLC.(6) The majority of all NSCLC
patients are diagnosed with advanced disease while approximately
25-30% present with resectable disease at diagnosis.(1-3)
For those with resectable tumours, the majority of patients
eventually develop recurrence despite complete tumour resection and
adjuvant chemotherapy.(4) Early-stage lung cancer diagnoses are
often only made when the cancer is found on imaging for an
unrelated condition.(7-8)
Approximately 10-15% of NSCLC patients in the US and Europe, and
30-40% of patients in Asia have EGFRm NSCLC.(9-11) These patients
are particularly sensitive to treatment with EGFR-tyrosine kinase
inhibitors (TKIs) which block the cell-signalling pathways that
drive the growth of tumour cells.(12)
ADAURA
ADAURA is a randomised, double-blinded, global,
placebo-controlled Phase III trial in the adjuvant treatment of 682
patients with Stage IB, II, 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 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 is DFS in Stage II and IIIA
patients and a key secondary endpoint is DFS in Stage IB, II and
IIIA patients. The data readout was originally anticipated in 2022.
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 have
received approval in the US, Japan, China, the EU and many
countries around the world for 1st-line EGFRm advanced NSCLC and
EGFR T790M mutation-positive advanced NSCLC.
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,
several stages of disease, lines of therapy and modes of
action.
AstraZeneca aims to address the unmet needs of patients with
EGFRm tumours as a genetic driver of disease with the approved
medicines Iressa (gefitinib) and Tagrisso and its ongoing LAURA,
NeoADAURA and FLAURA2 Phase III trials.
AstraZeneca is committed to addressing tumour mechanisms of
resistance through the ongoing SAVANNAH and ORCHARD Phase II
trials, which test Tagrisso in combination with savolitinib, a
selective inhibitor of c-MET receptor tyrosine kinase, along with
other potential new medicines.
AstraZeneca in oncology
AstraZeneca has a deep-rooted heritage in oncology and offers a
quickly growing portfolio of new medicines that has the potential
to transform patients' lives and the Company's future. With seven
new medicines launched between 2014 and 2020, and a broad pipeline
of small molecules and biologics in development, the Company is
committed to advance oncology as a key growth driver for
AstraZeneca focused on lung, ovarian, breast and blood cancers.
By harnessing the power of six scientific platforms -
Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage
Response, Antibody Drug Conjugates, Epigenetics and Cell Therapies
- and by championing the development of personalised combinations,
AstraZeneca has the vision to redefine cancer treatment 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
For details on how to contact the Investor Relations Team,
please click here . For Media contacts, click here .
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. Datta D, et al. Preoperative Evaluation of Patients
Undergoing Lung Resection Surgery. Chest. 2003;123: 2096-2103.
4. Pignon et al. Lung Adjuvant Cisplatin Evaluation: A Pooled
Analysis by the LACE Collaborative Group. J Clin Oncol
2008;26:3552-3559.
5. World Health Organization. International Agency for Research
on Cancer. Lung Fact Sheet. Available at
http://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf
. Accessed August 2020.
6. LUNGevity Foundation. Types of Lung Cancer. Available at
https://www.lungevity.org/about-lung-cancer/lung-cancer-101/types-of-lung-cancer
. Accessed August 2020.
7. Sethi S, et al. Incidental Nodule Management - Should There
Be a Formal Process?. Journal of Thorac Onc. 2016:8;S494-S497.
8. LUNGevity Foundation. Screening and Early Detection.
Available at:
https://lungevity.org/for-patients-caregivers/lung-cancer-101/screening-early-detection#1
. Accessed August 2020.
9. 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.
10. 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.
11. 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.
12. 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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