Form 6-K ASTRAZENECA PLC For: November 16



[ad_1]


Enter Wall Street with StreetInsider Premium. Claim your free 2 week trial here.


FORM 6-K

SECURITIES
AND EXCHANGE COMMITTEE

Washington,
D.C. 20549

report
foreign issuer

By virtue of
Rule 13a-16 or 15d-16 of

the
Securities Exchange Act of 1934

For the
month of November
2018

commission
File number: 001-11960

AstraZeneca PLC

1
Francis Crick Avenue

Cambridge
Biomedical Campus

Cambridge
CB2 0AA

United
Kingdom

Indicate
check if the declarant files or lodges each year
returns under form 20-F or Form 40-F.

Form
20-F X Form 40-F __

Indicate
Checkmark if registrant submits Form 6-K on paper
as permitted by Rule 101 (b) (1) of Regulation S-T:

Indicate
Checkmark if registrant submits Form 6-K on paper
as permitted by Rule 101 (b) (7) of the S-T Regulation: ______

Indicate
check if the declarant providing the information
content in this form also provides the information
to the Commission in accordance with Rule 12g3-2 (b) of Title
Exchange Act of 1934.

Yes __
No X

Yes
"Yes" is marked, indicate below the file number
assigned to the holder with respect to Rule 12g3-2.b):
82 -_____________

AstraZeneca PLC

INDEX
TO EXHIBIT

1.

AstraZeneca
takes stock of phase III of MYSTIC

This ad contains inside information

November 16, 2018 07:00 GMT

AstraZeneca takes stock of the MYSTIC Phase III trial
of


Imfinzi and tremelimumab in non-small cell stage IV
lung cancer

AstraZeneca and MedImmune, its global research network for biologics and
development arm, announced today the final overall survival (OS)
Results of the MYSTIC Phase III Trial, a Randomized Open-Label Study,
multicenter global trial of Imfinzi monotherapy (durvalumab) and the combination
of
Imfinziand tremelimumab, an anti-CTLA4 antibody, versus
platinum-based standard chemotherapy in patients
untreated patients previously with stage IV stage IV (metastatic)
lung cancer (NSCLC).

In the primary analysis population of patients, including tumors
express PD-L1 on 25% or more of their cancer cells, as determined by
the VENTANA PD-L1 test (SP263), Imfinzi monotherapy and combination
of
Imfinzi plus tremelimumab does not meet primary criteria
improvement parameters of SG compared to SoC chemotherapy. While the
The result of the SG did not correspond to the statistical significance, a risk ratio
(HR) 0.76 (CI 97.54% 0.564-1.019, nominal p = 0.036).
with
Imfinzimonotherapy. The combined therapy had a HR of
0.85 (CI 98.77% 0.611-1.173, nominal p = 0.202); the data carrier
further analysis in exploratory subgroups.

Safety and tolerability profiles for Imfinzi and the Imfinzi the more the combination of tremelimumab were
compatible with previous tests.

Sean Bohen, Executive Vice President, Global Drug Development
Chief Medical Officer, said: "We are encouraged to see
this Imfinzi the activity of monotherapy is in line with that of
the anti-PD-1 class in previously untreated patients with stage IV
non-small cell lung cancer; however, we are disappointed that these
the results lacked statistical significance. We remain confident
in
Imfinzias the cornerstone of our IO program and
continue to evaluate its potential in the ongoing non-small-cell lung
cancer trials, including
Imfinzi and Imfinzi plus tremelimumab in combination with
chemotherapy."

Imfinzi is approved for
Stage III NSCLC not resectable in more than 40 countries, including
United States, EU and Japan, based on Phase III of PACIFIC
trial.
Imfinzi is currently being tested in a range of
Phase III trials for Stage IV NSCLC.

Phase III immuno-oncology trials in phase IV, 1st line
NSCLC

PEARL

Imfinzi monotherapy vs chemotherapy SoC

NEPTUNE

Imfinzi + Tremelimumab vs SoC chemotherapy

POSEIDON

Imfinzi + chemotherapy or Imfinzi + tremelimumab +
chemotherapy

vs SoC
chemotherapy

About MYSTIC

The MYSTIC trial is a global randomized, open, multicenter study.
Phase III trial of Imfinzimonotherapy (durvalumab)
or
Imfinzi in combination with tremelimumab versus SoC
chemotherapy in the first-line treatment of patients with epidermitis
growth factor (EGFR) and anaplastic lymphoma kinase (ALK)
non-small, wild-type, locally advanced or metastatic (stage IV) cells
lung cancer.

The trial took place in 167 centers in 17 countries.
including the United States, Canada, Europe, Russia, Australia and parts of
Asia, including Japan, Korea, Thailand, Taiwan and Vietnam. Primary
The outcome measures included progression-free survival (PFS)
combination and OS in monotherapy and combination therapy. the
combination of Imfinzi and the tremelimumab did not meet the primary
criterion for improvement of SSP compared to SoC in patients whose tumors
express PD-L1 on 25% or more of their cancer cells in July
2017


Sure 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, counteracting the tumor
tactics of immune evasion and relaxing immunity inhibition
the answers.

Imfinzi is approved for
Stage III NSCLC not resectable in more than 40 countries, including
the United States, the EU and Japan on the basis of Phase III of PACIFIC
trial.
Imfinzi is also approved for pre-treatment
patients with advanced bladder cancer in the United States, Canada, Brazil,
Israel, India, United Arab Emirates, Australia and Hong Kong
Kong.

As part of an extensive development program, Imfinzi is also tested in monotherapy and in
combination with tremelimumab, an anti-CTLA4 monoclonal antibody
and potential new drugs, as a treatment for NSCLC patients,
small cell lung cancer (CPPC), bladder cancer, head and neck cancer
and other solid tumors.

About tremelimumab

Tremelimumab is a human monoclonal antibody and a new potential
drug that targets cytotoxic activity
T-Cell Protein 4 (CTLA-4). Tremelimumab blocks the
CTLA-4 activity, contributing to T cell activation and stimulation
the immune response to cancer. Tremelimumab is tested in a
clinical trial program in combination
with Imfinzi NSCLC, urothelial carcinoma, head and
squamous cell carcinoma of the neck, hepatocellular carcinoma and hemorrhage
cancers.

About Stage IV NSCLC

Lung cancer is the leading cause of cancer death in men and women
about one-fifth of all cancer deaths: more
combined breast, prostate and colorectal cancers. Lung cancer
is widely divided between NSCLC and SCLC, with 80-85% classified as
NSCLC. Stage IV is the most advanced form of lung cancer and is
often called metastatic disease. About 85% of the stage
IV patients are diagnosed after the spread of the tumor outside of
lung. For these patients, the prognosis is particularly bad,
only 1 in 10 will be alive five years after diagnosis.

About AstraZeneca in lung cancer

AstraZeneca has a comprehensive portfolio of approved and potential solutions.
new drugs in advanced clinical development phase for treatment
different forms of lung cancer covering several stages of
disease and treatment lines. We aim to meet the unmet needs of
patients with tumors mutated by EGFR as a genetic factor of the disease,
occur in 10 to 15% of patients with NSCLC in the United States and the EU and in 30 to 40% of patients.
NSCLC patients in Asia, with our approved
medication Iressa and Tagrisso and during FLAURA, ADAURA and LAURA
Trials III.

Our extensive program of advanced immuno-oncology is focused on
75-80% of patients with lung cancer without known genetics
mutation. Imfinzi, an anti-PDL1 antibody is under development
monotherapy (ADJUVANT BR.31, PACIFIC-2, PACIFIC-5, MYSTIC and PEARL
Phase III) and in combination with tremelimumab and / or
chemotherapy (phases MYSTIC, NEPTUNE, POSEIDON, ADRIATIC and CASPIAN)
Trials III).

About the AstraZeneca approach to immuno-oncology

IO is a therapeutic approach designed to stimulate the body
immune system to attack tumors. At AstraZeneca and MedImmune, our
arm of research and development of organic products, our IO portfolio is
anchored by immunotherapies designed to overcome
anti-tumor immune suppression. We believe that IO-based therapies
offer the potential of cancer treatments that will change the life of the
clear majority of patients.

We are pursuing a comprehensive program of clinical trials that
comprises Imfinzi (anti-PDL1) in monotherapy and at
combination with tremelimumab (anti-CTLA4) in the treatment of multiple tumors
types, stages of the disease and treatment lines, using PD-L1
biomarker as a decision support tool to define the best potential
treatment route for a patient. In addition, the possibility of combining
our IO portfolio with targeted small molecules from our
The oncology pipeline and our research partners can provide new
treatment options on a wide range of
you die.

About AstraZeneca in Oncology

AstraZeneca has a deep-rooted heritage in oncology and offers a
fast-growing portfolio of new drugs that has the potential
transform the lives of patients and the future of society. With a
least six new drugs to be launched between 2014 and 2020, and one
wide pipeline of small molecules and biologics developing we
committed to making oncology an important growth driver for
AstraZeneca's focus is on lung, ovarian, breast and blood cancers. In
In addition to our core capabilities, we are actively pursuing
partnerships and investments that accelerate the delivery of our
strategy illustrated by our investment in Acerta Pharma in
hematology.

By harnessing the power of four scientific platforms –
Immuno-oncology, tumor resistance factors and resistance to DNA degradation
and conjugates of antibody medications – and defending the development
customized combinations, AstraZeneca has the vision of
redefine the treatment of cancer and eventually eliminate cancer as a cause
of death.

About MedImmune

MedImmune is the global research and development arm for organic products
AstraZeneca, a global biopharmaceutical company focused on innovation
which focuses on the discovery, development and commercialization of
prescription drugs based on small molecules and biological drugs. MedImmune is
pioneering innovative research and exploring new paths through
Oncology; Respiratory; Cardiovascular, Renal & Metabolic
diseases; and infection and vaccines. The headquarters of MedImmune is
located in Gaithersburg, Maryland, one of the three largest AstraZeneca groups.
R & D centers, with additional sites in Cambridge, UK and South
San Francisco, 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 commercialization of
prescription drugs, primarily for the treatment of diseases in
three therapeutic areas – oncology, cardiovascular, renal and
Metabolism and Respiratory. AstraZeneca operates in more than 100
country and its innovative medicines are used by millions of
patients around the world. For more information, please
visit www.astrazeneca.com and
follow us on Twitter @AstraZeneca.

CONTACTS

Media
Reports

karen
Birmingham

UK / Global

+44 203
749 5634

Rob
Skelding

UK / Global

+44 203
749 5821

Mast
Kent

UK / Global

+44 203
749 5906

Gonzalo
Viña

UK / Global

+44 203
749 5916

Jennifer
Hursit

UK / Global

+44 2033749
5762

Jacob
Lund

Sweden

46
8,553,260 20

Michele
Meixell

WE

+1 302
885 2677

Investor
Reports

Thomas
Kudsk Larsen

+44 203
749 5712

Henry
Wheeler

Oncology

+44 203
749 5797

Christer
Gruvris

Cardiovascular;
Metabolism

+44 203
749 5711

Notch
Pierre

Respiratory;
Renal

+44 203
749 5716

Josie
Afolabi

Other

+44 203
749 5631

Craig
Marks

Finance;
Fixed income

44
7881 615 764

Jennifer
Kretzmann

Retail
investors

+44 203
749 5824

WE
free

+1 866
381 7277

Adrian Kemp

Secretary of the Society

AstraZeneca PLC

SIGNATURES

By virtue of
to the requirements of the Securities Exchange Act of 1934, the
The holder has duly signed this report on his behalf
by the undersigned, duly authorized.

Date:
November 16th
2018

By: / s /
Adrian Kemp

First name:
Adrian Kemp

Title:
Secretary of the Society

[ad_2]
Source link