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11/29/2019 | Press release | Distributed by Public on 11/29/2019 01:00

Imfinzi granted FDA Priority Review for SCLC

Imfinzi granted FDA Priority Review for SCLC
29 November 2019 07:00 GMT



Imfinzi granted FDA Priority Review for the treatment
of patients with extensive-stage small cell lung cancer

AstraZeneca today announced that the US Food and Drug Administration (FDA) has
accepted a supplemental Biologics License Application (sBLA) and granted
Priority Review for Imfinzi (durvalumab) for the treatment of patients with
previously untreated extensive-stage small cell lung cancer (SCLC).
SCLC is an aggressive, fast-growing form of lung cancer that recurs and
progresses rapidly despite initial response to platinum-based chemotherapy.[1] A
Prescription Drug User Fee Act date is set for the first quarter of 2020.
The sBLA was based on positive results from the Phase III CASPIAN trial
published in The
Lancet (https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)32222
-6/fulltext), showing Imfinzi in combination with standard-of-care (SoC)
chemotherapy (etoposide with either cisplatin or carboplatin) demonstrated a
statistically significant and clinically meaningful improvement in overall
survival (OS) vs. SoC. The risk of death was reduced by 27% (equal to a hazard
ratio of 0.73), with median OS of 13.0 months for Imfinzi plus chemotherapy vs.
10.3 months for SoC. Results showed an estimated 33.9% of patients were alive at
18 months following treatment with Imfinzi plus chemotherapy vs. 24.7% of
patients receiving SoC.
Imfinzi is approved in the curative-intent setting of unresectable, Stage III
non-small cell lung cancer (NSCLC) after chemoradiation therapy in 54 countries,
including the US, Japan and the EU, based on the Phase III PACIFIC trial.



About CASPIAN

CASPIAN is a randomised, open-label, multi-centre, global, Phase III trial in
the 1st-line treatment of patients with extensive-stage SCLC. The trial
compared Imfinzi in combination with etoposide and either cisplatin or
carboplatin chemotherapy, or Imfinzi, tremelimumab and chemotherapy vs.
chemotherapy alone. In the experimental arms, patients were treated with up to
four cycles of chemotherapy. In comparison, the control arm allowed up to six
cycles of chemotherapy and prophylactic cranial irradiation. The trial will
continue to the final analysis of OS for the combination of Imfinzi,
tremelimumab and chemotherapy. The trial is being conducted in more than 200
centres across 23 countries, including the US, Europe, South America, Asia and
the Middle East. The primary endpoint is OS.

About small cell lung cancer

Lung cancer is the leading cause of cancer death among both men and women and
accounts for about one-fifth of all cancer deaths.[2] Lung cancer is broadly
split into NSCLC and SCLC, with about 15% classified as SCLC.[3] About three
quarters of SCLC patients are diagnosed with extensive-stage disease, in which
the cancer has spread widely through the lung or to other parts of the body.
Prognosis is particularly poor, as only 6% of all SCLC patients will be alive
five years after diagnosis.[4]

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 also approved for previously treated patients with advanced bladder
cancer in 11 countries, including the US.

As part of a broad development programme, Imfinzi is also being tested as a
monotherapy and in combination with tremelimumab, an anti-CTLA4 monoclonal
antibody and potential new medicine, as a treatment for patients with NSCLC,
SCLC, bladder cancer, head and neck cancer, liver cancer, biliary tract cancer,
cervical cancer and other solid tumours.

About AstraZeneca in lung cancer

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 spanning several stages of disease, lines of therapy and
modes of action. 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 (gefitinib) and Tagrisso (osimertinib), and ongoing Phase III
trials ADAURA, LAURA, and FLAURA2 as well as the Phase II combination trials
SAVANNAH and ORCHARD.[5-7]

Our extensive late-stage Immuno-Oncology programme focuses on lung cancer
patients without a targetable genetic mutation which represents approximately
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, PEARL, and CASPIAN) 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.

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. The Company's IO portfolio is anchored by
immunotherapies that have been designed to overcome anti-tumour immune
suppression. AstraZeneca believes that IO-based therapies offer the potential
for life-changing cancer treatments for the majority of patients.

The Company is pursuing a comprehensive clinical-trial programme that
includes Imfinzi as a monotherapy and in combination with tremelimumab 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
radiation, chemotherapy, small targeted molecules from across AstraZeneca's
Oncology pipeline, and from 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, 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.

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 and Metabolism, and Respiratory. 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 Company on Twitter @AstraZeneca (https://twitter.com/AstraZeneca).



Media Relations
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Rob Skelding     Oncology                  +44 203 749 5821
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Malmberg
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Relations
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Larsen
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Gruvris          Metabolism)
Nick Stone       BioPharmaceuticals        +44 203 749 5716
                 (Renal), ESG
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References

1.     Kalemkerian GP, et al. Treatment Options for Relapsed Small-Cell Lung
Cancer: What Progress Have We Made? Journal of Oncology Practice, volume 14,
issue no. 6 (June 1, 2018) 369-370.

2.     World Health Organization. International Agency for Research on Cancer.
Available at http://globocan.iarc.fr/Pages/fact_sheets_population.aspx Accessed
November 2019.

3.     LUNGevity Foundation. Types of Lung Cancer. Available
at https://lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung
-cancer Accessed November 2019.

4.     Cancer.Net. Lung Cancer - Small Cell. Available
at https://www.cancer.net/cancer-types/33776/view-all Accessed November 2019.

5.     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.

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.



Adrian Kemp
Company Secretary
AstraZeneca PLC



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