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2020-05-28

AstraZeneca: Tagrisso demonstrated unprecedented disease-free survival in the adjuvant treatment of Stage IB-IIIA patients ...

Phase III ADAURA trial showed treatment with Tagrisso after surgery
with curative intent reduced the risk of disease recurrence or death
by c. 80%

Detailed results from the Phase III ADAURA trial showed AstraZeneca's
Tagrisso (osimertinib) demonstrated a statistically significant and
clinically meaningful improvement in disease-free survival (DFS) in
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.

Results will be presented during the plenary session of the American
Society of Clinical Oncology ASCO20 Virtual Scientific Program on 31
May (abstract #LBA5).

In the primary endpoint of DFS in patients with Stage II and IIIA
disease, adjuvant treatment (after surgery) with Tagrisso reduced the
risk of disease recurrence or death by 83% (based on a hazard ratio
[HR] of 0.17; 95% confidence interval [CI] 0.12, 0.23; p<0.0001). DFS
results in the overall trial population, Stage IB through IIIA, a key
secondary endpoint, demonstrated a reduction in the risk of disease
recurrence or death of 79% (based on a HR of 0.21; 95% CI 0.16, 0.28;
p<0.0001).

At two years, 89% of patients in the trial treated with Tagrisso
remained alive and disease free versus 53% on placebo. Consistent DFS
results were seen across all subgroups, including patients who were
treated with surgery followed by chemotherapy and those who received
surgery only, as well as in Asian and non-Asian patients.

Roy S. Herbst, MD, Ph.D., chief of Medical Oncology at Yale Cancer
Center and Smilow Cancer Hospital, New Haven, CT and principal
investigator in the Phase III ADAURA trial, said: "These data are
transformative for patients with early-stage EGFR-mutated non-small
cell lung cancer who face high rates of recurrence even after
successful surgery and subsequent treatment with adjuvant
chemotherapy. Tagrisso will provide a much-needed new treatment
option that has the potential to change the practice of medicine and
improve outcomes for patients in this setting."

José Baselga, Executive Vice President, Oncology R&D, said: "The
momentous results of the Phase III ADAURA trial for Tagrisso
demonstrate for the first time in a global trial that an EGFR
inhibitor can change the course of early-stage EGFR-mutated lung
cancer and provide hope for a cure. We are discussing these
outstanding data with regulatory authorities and look forward to
bringing the benefits of Tagrisso to patients with early-stage
disease."

In April 2020
(https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2...),
an Independent Data Monitoring Committee recommended for the Phase
III ADAURA trial to be unblinded two years early based on its
determination of overwhelming efficacy. At the time of data cut-off,
overall survival (OS) data favoured Tagrisso, but were not mature.
The trial will continue to assess OS as a secondary endpoint.

Summary of ADAURA results

[][]
Tagrisso Placebo
DFS Stages II-IIIA (primary endpoint)[i] (n=233) (n=237)
HR (95% CI) 0.17 (0.12, 0.23)
p-value p<0.0001
DFS rates (95% CI)
One year 97% (94%, 99%) 61% (54%, 67%)
Two years 90% (84%, 93%) 44% (37%, 51%)
Three years 80% (68%, 88%) 28% (19%, 38%)
DFS Stages IB-IIIA (secondary endpoint)[i] (n=339) (n=343)
HR (95% CI) 0.21 (0.16, 0.28)
p-value p<0.0001
DFS rates (95% CI)
One year 97% (95%, 99%) 69% (63%, 73%)
Two years 89% (84%, 92%) 53% (47%, 59%)
Three years 79% (69%, 86%) 41% (33%, 49%)

i The data cut-off date for DFS was 17 January 2020.

The safety and tolerability of Tagrisso in this trial was consistent
with previous trials in the metastatic setting. Adverse events at
Grade 3 or higher from all causes occurred in 10% of patients in the
Tagrisso arm versus 3% in the placebo arm as assessed by the
investigator.

Tagrisso is approved for the 1st-line treatment of patients with
locally advanced or metastatic EGFRm NSCLC in the US, Japan, China,
the EU and many other countries around the world.

Several presentations featured during the ASCO20 Virtual Scientific
Program will showcase AstraZeneca's leadership in lung cancer
(https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2...)
across early and late-stage disease and reinforce the Company's
biomarker-driven approach.

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, with
80-85% classified as NSCLC.[2] A significant portion of patients with
resectable NSCLC eventually develop recurrence despite surgery
(complete resection).[3,4] Approximately 10-15% of NSCLC patients in
the US and Europe, and 30-40% of patients in Asia have EGFRm
NSCLC.[5-7] 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.[8]
Approximately 25-30% of patients with NSCLC present with resectable
disease at diagnosis.[9-11]

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 adjuvant
chemotherapy as indicated. 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 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 OS as a
secondary endpoint.

Tagrisso

Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI
with clinical activity against CNS 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. Tagrisso is also being developed in the Stage III,
unresectable setting (LAURA), in combination with chemotherapy
(FLAURA2) and in combination 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.
AstraZeneca aims 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 LAURA, and FLAURA2.[5-7]

AstraZeneca is 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.[12]
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 MERMAID-1, 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 trials NeoCOAST, COAST and HUDSON
in combination with potential new medicines from the early-stage
pipeline including Enhertu.

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 & 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 (http://www.astrazeneca.com/)
and follow the Compan...

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