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2020-04-10

AstraZeneca: Tagrisso Phase III ADAURA trial will be unblinded early after overwhelming efficacy in the adjuvant treatment ...

ADAURA is the first global trial for an EGFR inhibitor to show
statistically significant and clinically meaningful benefit in
adjuvant treatment of lung cancer

Plans for regulatory submission already underway

The ADAURA Phase III trial for Tagrisso (osimertinib) in the adjuvant
treatment of patients with Stage IB, II and IIIA epidermal growth
factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC)
with complete tumour resection will be unblinded early following a
recommendation from an Independent Data Monitoring Committee (IDMC)
based on its determination of overwhelming efficacy.

José Baselga, Executive Vice President, Oncology R&D, said: "We are
thrilled by the recommendation to unblind the Phase III ADAURA trial
much earlier than expected and are incredibly excited with these
unprecedented results in patients with early-stage EGFR-mutated
non-small cell lung cancer. Lung cancer is a devastating diagnosis
and for the first time an EGFR-targeted medicine can now provide the
hope of cure."

The primary endpoint of the Phase III ADAURA trial is disease-free
survival (DFS). Tagrisso was assessed against placebo for a treatment
duration of up to three years. The trial will continue to assess the
secondary endpoint of overall survival. In its communication to
AstraZeneca, the IDMC did not raise any new safety concerns. The data
will be presented at a forthcoming medical meeting.

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, more than
breast, prostate and colorectal cancers combined.[1] Lung cancer is
broadly split into NSCLC and small cell lung cancer, with 80-85%
classified as NSCLC.[2] Approximately 10-15% of NSCLC patients in the
US and Europe, and 30-40% of patients in Asia have EGFRm
NSCLC.[3,4,5] 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. Based
on AstraZeneca estimates, just over 60% of NSCLC patients are
diagnosed with early-stage (Stage I-III) disease.

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 with complete tumour resection and optional,
standard post-operative adjuvant chemotherapy. In the experimental
arm, patients were treated with Tagrisso 80mg once-daily oral tablets
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; data readout was originally anticipated in 2022.

Tagrisso

Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI
designed to inhibit both EGFR-sensitising and EGFR T790M-resistance
mutations, with clinical activity against CNS metastases. Tagrisso
40mg and 80mg once-daily oral tablets have now received approval in
80 countries, including the US, Japan, China and the EU, for 1st-line
EGFRm advanced NSCLC, and in 87 countries, including the US, Japan,
China and the EU, for 2nd-line use in patients with EGFR T790M
mutation-positive advanced NSCLC. Tagrisso is also being developed in
the locally advanced unresectable setting (LAURA), in combination
with chemotherapy (FLAURA2) in the metastatic setting, and with
potential new medicines to address resistance to EGFR-TKIs (SAVANNAH,
ORCHARD).

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. We
aim to address the unmet needs of patients with EGFRm tumours as a
genetic driver of disease, which occur in 10-15% of NSCLC patients in
the US and EU and 30-40% of NSCLC patients in Asia, with the approved
medicines Iressa (gefitinib) and Tagrisso, and its ongoing Phase III
trials ADAURA, LAURA, and FLAURA2.[3,6-7]

We are also committed to addressing tumour mechanisms of resistance
through the ongoing Phase II trials SAVANNAH and ORCHARD which test
Tagrisso in combination with savolitinib, a selective inhibitor of
c-MET receptor tyrosine kinase, along with other potential new
medicines. Enhertu (trastuzumab deruxtecan), a HER2-directed antibody
drug conjugate is in development for metastatic non-squamous
HER2-overexpressing or HER2-mutated NSCLC including trials in
combination with other anticancer treatments.

An extensive late-stage Immuno-Oncology programme focuses on lung
cancer patients without a targetable genetic mutation which
represents up to three-quarters of all patients with lung cancer.[8]
Imfinzi, an anti-PDL1 antibody, is in development for patients with
advanced disease (Phase III trials POSEIDON and PEARL) and for
patients in earlier stages of disease including potentially curative
settings (Phase III trials AEGEAN, ADJUVANT BR.31, PACIFIC-2,
PACIFIC-4, PACIFIC-5, and ADRIATIC) both as monotherapy and in
combination with tremelimumab and/or chemotherapy. Imfinzi is also in
development in the Phase II combination trials NeoCOAST, COAST and
HUDSON in combination with potential new medicines from the
early-stage pipeline.

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 six 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. In addition to
AstraZeneca's main capabilities, the Company is actively pursuing
innovative partnerships and investments that accelerate the delivery
of our strategy, as illustrated by the investment in Acerta Pharma in
haematology.

By harnessing the power of four scientific platforms -
Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response
and Antibody Drug Conjugates - 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/NYSE: 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 and Metabolism, and Respiratory. 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
(https://www.astrazeneca.com/investor-relations.html#Contacts). For
Media contacts, click here
(https://www.astrazeneca.com/media-centre/contacts.html).

References

1. World Health Organization. International Agency for Research on
Cancer. Globocan Worldwide Fact Sheet 2018. Available at
http://globocan.iarc.fr/Pages/fact_sheets_population.aspx.

2. LUNGevity Foundation. Types of Lung Cancer. Available at
https://www.lungevity.org/about-lung-cancer/lung-cancer-101/types-of-lun....

3. Szumera-Cie?kiewicz 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.

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;2121-27.

5. 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.

6. 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.

7. 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.

8. Pakkala, S, et al. Personalized Therapy for Lung Cancer: Striking a
Moving Target. JCI Insight. 2018;3(15):e120858.

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