FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of June
2019
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Imfinzi improves
overall survival at interim
This announcement
contains inside information
27 June 2019 07:00 BST
Imfinzi improves overall survival at interim
analysis in the Phase III CASPIAN trial in 1st-line extensive-stage
small cell lung cancer
Trial showed statistically-significant and
clinically-meaningful
benefit in patients with the most aggressive type of lung
cancer
AstraZeneca today announced positive overall survival (OS) results
from the Phase III CASPIAN trial with Imfinzi in 1st-line extensive-stage small cell lung
cancer (SCLC), a disease with significant unmet need and limited
treatment options for patients.
A planned interim analysis conducted by an Independent Data
Monitoring Committee concluded that the trial has met its primary
endpoint by showing a statistically-significant and
clinically-meaningful improvement in OS in patients treated
with Imfinzi in combination with standard-of-care
etoposide and platinum-based chemotherapy options vs.
chemotherapy alone. The safety and tolerability for
this Imfinzi combination was consistent with the
known safety profiles of these medicines.
AstraZeneca will submit these results for presentation at a
forthcoming medical meeting.
José Baselga, Executive Vice President, Oncology R&D
said: "The Phase III CASPIAN results offer new hope for patients
who are facing the devastating diagnosis of small cell lung cancer,
and for whom new medicines are urgently needed. This is
the first trial offering the flexibility of combining
immunotherapy with different platinum-based regimens in small cell
lung cancer, expanding treatment options."
CASPIAN is a randomised, open-label, multi-centre, global, Phase
III trial of Imfinzi plus platinum-based chemotherapy options or
the combination of Imfinzi, tremelimumab and chemotherapy vs.
chemotherapy alone as a 1st-line treatment for patients with
extensive-stage SCLC. The trial will continue to the final analysis
of OS for the combination of dual immune checkpoint blockade with
chemotherapy. This combination includes tremelimumab, an anti-CTLA4
antibody and potential new medicine, with Imfinzi, an anti-PDL1 antibody, and
chemotherapy.
Imfinzi is also being
tested following concurrent chemoradiation therapy in limited-stage
SCLC in the Phase III ADRIATIC trial.
Imfinzi is approved for
unresectable, Stage III non-small cell lung cancer in more than 45
countries, including the US, EU and Japan, based on the Phase III
PACIFIC trial.
About CASPIAN
The CASPIAN trial 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 is being conducted in more than 200 centres across 22
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.1 Lung
cancer is broadly split into NSCLC and SCLC, with about 15%
classified as SCLC.2 About
two-thirds 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.3 SCLC
is an aggressive, fast-growing cancer that recurs and progresses
rapidly despite initial response to platinum-based
chemotherapy.4 Prognosis
is particularly poor, as only 6% of all SCLC patients will be alive
five years after diagnosis.3
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 the
US, Canada, Brazil, Australia, Israel, India, United Arab Emirates,
Qatar, Macau and Hong Kong.
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,
small cell lung cancer, bladder cancer, head and neck cancer, liver
cancer, cervical cancer, biliary tract cancer and other solid
tumours.
About tremelimumab
Tremelimumab is a human monoclonal antibody and potential new
medicine that targets the activity of cytotoxic
T-lymphocyte-associated protein 4 (CTLA-4). Tremelimumab blocks the
activity of CTLA-4, contributing to T cell activation and boosting
the immune response to cancer. Tremelimumab is being tested in a
clinical trial programme in combination
with Imfinzi in NSCLC, bladder cancer, head and neck
cancer, liver cancer and blood cancers.
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 FLAURA, ADAURA and LAURA as well as the Phase II exploratory
combination trials SAVANNAH and ORCHARD.5-7
Our extensive late-stage Immuno-Oncology programme focuses on lung
cancer patients without a known genetic mutation which represents
up to 50% of all patients with lung
cancer. Imfinzi(durvalumab),
an anti-PDL1 antibody, is in development as monotherapy (Phase III
trials ADJUVANT BR.31, PACIFIC-4, PACIFIC-5, and PEARL) and in
combination with tremelimumab and/or chemotherapy (AEGEAN,
PACIFIC-2, NEPTUNE, POSEIDON, ADRIATIC and CASPIAN Phase III
trials).
About AstraZeneca's approach to Immuno-Oncology (IO)
IO is a therapeutic approach designed to stimulate the body's
immune system to attack tumours. Our IO portfolio is anchored by
immunotherapies that have been designed to overcome anti-tumour
immune suppression. We believe that IO-based therapies 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 from 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 advance Oncology as a key 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 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 astrazeneca.com and
follow us on Twitter @AstraZeneca.
Media
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Adrian Kemp
Company Secretary
AstraZeneca PLC
References
1. World Health Organization. International Agency for Research on
Cancer. Available at http://globocan.iarc.fr/Pages/fact_sheets_population.aspx.
Accessed May 2019.
2. LUNGevity Foundation. Types of Lung Cancer. Available
at https://lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer.
Accessed May 2019.
3. Cancer.Net. Lung Cancer - Small Cell. Available
at https://www.cancer.net/cancer-types/33776/view-all.
Accessed May 2019.
4. 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.
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.
Accessed May 2019.
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.
Accessed May 2019.
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. Accessed
May 2019.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
Date:
27 June
2019
|
By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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