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2018-09-25

AstraZeneca: Imfinzi is the first immunotherapy to demonstrate significant overall survival benefit in unresectable, Stage ...

Imfinzi reduced the risk of death by nearly one third compared to
standard of care in the Phase III PACIFIC trial

Updated data reaffirm unprecedented improvement in progression-free
survival of more than 11 months

AstraZeneca and MedImmune, its global biologics research and
development arm, have presented data on overall survival (OS) in the
Phase III PACIFIC trial of Imfinzi during the Presidential Symposium
of the IASLC 19th World Conference on Lung Cancer hosted by the
International Association for the Study of Lung Cancer in Toronto,
Canada.

Results from the Phase III PACIFIC trial were published simultaneously
in the New England Journal of Medicine, showing Imfinzi (durvalumab)
significantly improved OS, the second primary endpoint of the trial,
compared to standard of care regardless of PD-L1 expression, reducing
the risk of death by 32% (HR 0.68, 99.73% CI 0.47-0.997; p=0.0025).

Sean Bohen, Executive Vice President, Global Medicines Development and
Chief Medical Officer, said: "These data establish Imfinzi as the
first immunotherapy to demonstrate an overall survival benefit for
patients with unresectable, Stage III non-small cell lung cancer
following chemoradiation therapy. Today's announcement brings new
hope to patients in a setting where survival rates have not changed
in decades."

Scott J. Antonia, MD, Ph.D., chair of the Thoracic Oncology Department
at Moffitt Cancer Center in Tampa, Florida, USA and principal
investigator in the PACIFIC trial said: "The five-year survival rate
in this setting has historically been around 15% after concurrent
chemoradiation therapy. The significant survival benefit observed
using the PACIFIC regimen provides confidence and clear rationale for
a new standard of care."

Summary of primary endpoints

Imfinzi (n=476) Placebo(n=237)
OS (primary endpoint)1
Number of deaths (%) 183 (38.4%) 116 (48.9%)
Hazard ratio (99.73% CI)2,3 0.68 (0.47, 0.997)
p-value2-4 0.0025
Median in months (95% CI) NR5(34.7, NR) 28.7(22.9, NR)
PFS (primary endpoint)1,6
Number (%) of patients with event 243 (51.1%) 173 (73.0%)
Hazard ratio (95% CI)2,7 0.51 (0.41, 0.63)
Median in months (95% CI) 17.2(13.1, 23.9) 5.6(4.6, 7.7)

1.The data cut-off date for analysis of OS and updated analysis of PFS
was 22 March 2018.

2. Stratified by sex, age, and smoking history.

3. Confidence interval adjusted for interim analysis.

4. Criteria for statistical significance at the interim analysis of OS
was a p-value ? 0.00274 (using Lan DeMets spending function
approximating O'Brien Fleming boundary).

5. Not Reached (NR).

6. Assessed by Blinded Independent Central Review (BICR) according to
RECIST v1.1.

7. No formal statistical comparison was made because the study had
achieved significance for PFS at the first planned interim analysis
(data cutoff of Feb 13, 2017).

The safety and tolerability profile for Imfinzi was consistent with
that reported at the time of the progression-free survival (PFS)
analysis. Among patients receiving Imfinzi, the most common adverse
reactions (greater than or equal to 20% of patients) versus placebo
were cough (35.2% vs. 25.2%), fatigue (24.0% vs. 20.5%), dyspnea
(22.3% vs. 23.9%) and radiation pneumonitis (20.2% vs. 15.8%). 30.5%
of patients experienced a grade 3 or 4 AE with Imfinzi vs 26.1% with
placebo, and 15.4% of patients discontinued treatment due to AEs with
Imfinzi vs. 9.8% of patients on placebo.

Imfinzi is currently approved in the US, EU, Canada, Switzerland,
India, Japan and Brazil based on the PACIFIC trial. Other global
health authority reviews and submissions are ongoing.

About Stage III NSCLC

Stage III (locally-advanced) NSCLC is commonly divided into three
sub-categories (IIIA, IIIB and IIIC), defined by how much the cancer
has spread locally and the possibility of surgery. Stage III disease
is different from Stage IV disease, when the cancer has spread
(metastasised) to distant organs, as Stage III is currently treated
with curative intent.

Stage III NSCLC represents approximately one-third of NSCLC incidence
and was estimated to affect around 105,000 patients in the top-eight
countries (China, France, Germany, Italy, Japan, Spain, UK, US) in
2017. The majority of Stage III NSCLC patients are diagnosed with
unresectable tumours. No new treatments beyond chemoradiation
therapy, followed by active surveillance to monitor for progression,
have been available to patients for decades.

About PACIFIC

The PACIFIC trial is a Phase III, randomised, double-blinded,
placebo-controlled, multi-centre trial of Imfinzi as treatment in
`all-comer' patients (i.e. regardless of PD-L1 status) with
unresectable, Stage III (locally-advanced) NSCLC whose disease has
not progressed following platinum-based chemotherapy and radiation
therapy (CRT).

The trial is being conducted in 235 centres across 26 countries
involving 713 patients. The primary endpoints of the trial are PFS
and OS, and secondary endpoints include landmark PFS and OS,
objective response rate, and duration of response.

About Imfinzi

Imfinzi (durvalumab) is a human monoclonal antibody that binds to
PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80,
countering the tumour's immune-evading tactics and releasing the
inhibition of immune responses.

Imfinzi is approved for unresectable, Stage III NSCLC in the US, EU,
Canada, Switzerland, India, Japan, and Brazil based on the Phase III
PACIFIC trial. Imfinzi is also approved for the treatment of patients
with locally-advanced or metastatic urothelial carcinoma in the US,
Canada, Brazil, Israel, Hong Kong, and India.

As part of a broad development programme, Imfinzi is also being tested
as a monotherapy and in combination with chemotherapy, radiation
therapy, small molecules, and tremelimumab, an anti-CTLA4 monoclonal
antibody, as a first or second-line treatment for patients with
NSCLC, small cell lung cancer, locally-advanced or metastatic
urothelial carcinoma, head and neck cancer and other solid tumours.

About AstraZeneca in Lung Cancer

Lung cancer is the leading cause of cancer death among both men and
women, accounting for about one-third of all cancer deaths.

AstraZeneca has a comprehensive portfolio of approved and potential
new medicines in late-stage clinical development for the treatment of
different forms of lung cancer across all stages of disease and lines
of therapy. We aim to address the unmet needs of patients with
EGFR-mutated 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 our approved medicines Iressa and Tagrisso and
ongoing FLAURA, ADAURA and LAURA Phase III trials. Our extensive
late-stage immuno-oncology programme focuses on 75-80% of patients
with lung cancer without a known genetic mutation. Imfinzi, an
anti-PDL1 antibody is in development as monotherapy (ADJUVANT BR.31,
PACIFIC2, MYSTIC and PEARL Phase III trials) and in combination with
tremelimumab and/or chemotherapy (MYSTIC, NEPTUNE, POSEIDON and
CASPIAN Phase III trials).

About AstraZeneca's Approach to Immuno-Oncology (IO)

Immuno-Oncology (IO) is a therapeutic approach designed to stimulate
the body's immune system to attack tumours. At AstraZeneca and
MedImmune, our biologics research and development arm, our IO
portfolio is anchored by immunotherapies that have been designed to
overcome anti-tumour immune suppression. We believe that IO-based
therapies will offer the potential for life-changing cancer
treatments for the clear majority of patients.

We are pursuing a comprehensive clinical trial programme that includes
Imfinzi (anti-PDL1) as monotherapy and in combination with
tremelimumab (anti-CTLA4) in multiple tumour types, stages of
disease, and lines of therapy, using the PD-L1 biomarker as a
decision-making tool to define the best potential treatment path for
a patient. In addition, the ability to combine our IO portfolio with
small, targeted molecules from across our Oncology pipeline, and with
those of our research partners, may provide new treatment options
across a broad range of tumours.

About 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 at least six
new medicines to be launched between 2014 and 2020, and a broad
pipeline of small molecules and biologics in development, we are
committed to advancing Oncology as a growth driver for AstraZeneca,
focused on lung, ovarian, breast and blood cancers. In addition to
our core capabilities, we actively pursue innovative partnerships and
investments that accelerate the delivery of our strategy as
illustrated by our 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.

About MedImmune

MedImmune is the global biologics research and development arm of
AstraZeneca, a global, innovation-driven biopharmaceutical business
that focuses on the discovery, development and commercialisation of
small-molecule and biologic prescription medicines. MedImmune is
pioneering innovative research and exploring novel pathways across
Oncology; Respiratory; Cardiovascular, Renal & Metabolic Diseases;
and Infection and Vaccines. The MedImmune headquarters is located in
Gaithersburg, MD, one of AstraZeneca's three global R&D centres, with
additional sites in Cambridge, UK, and Mountain View, CA. For more
information, please visit www.medimmune.com.

About AstraZeneca

AstraZeneca 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. AstraZeneca operates in over 100 countries and its
innovative medicines are used by millions of patients worldwide.

For more information, please visit www.astrazeneca.com and follow us
on Twitter @AstraZeneca.

CONTACTS

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Karen UK/Global +44 203 749 5634
Birmingham
Rob UK/Global +44 203 749 5821
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