Blueprint
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 January 2017
Commission File
Number: 001-11960
AstraZeneca
PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge CB2
0AA
United
Kingdom
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12g3-2(b): 82-_____________
17
January 2017 07:00
ASTRAZENECA
EXPANDS 1ST-LINE LUNG CANCER
IMMUNO-ONCOLOGY
PROGRAMME OPPORTUNITIES
Refined endpoints and statistical analysis plan in the Phase III
MYSTIC trial
China regulatory submission opportunity strengthened with the
expansion of the Phase III NEPTUNE trial and the initiation of the
new Asia-focused Phase III PEARL trial
AstraZeneca today
provides an update on its Immuno-Oncology (IO) late-stage clinical
development programme in 1st-line non-small cell lung cancer
(NSCLC), including a refinement of the Phase III MYSTIC
trial.
The
MYSTIC trial was initially
designed to assess the benefit of durvalumab monotherapy and
durvalumab and tremelimumab (durva + treme) combination therapy
versus standard-of-care (SoC) chemotherapy, focused on
progression-free survival (PFS).
The
MYSTIC trial will now assess PFS and overall survival (OS)
endpoints in patients with PDL1-expressing tumours for both
durvalumab monotherapy and the combination of durva + treme, as
well as in 'all comers' for the combination of durva + treme,
versus SoC chemotherapy.
While
the focus remains on exploring the benefit of durva + treme as
combination therapy, the Company has updated the endpoints of the
MYSTIC trial to include OS and PFS in durvalumab monotherapy. This
is based on recent internal and external data, including
durvalumab's strong efficacy in monotherapy presented at recent
medical meetings, as well as significant opportunities in the
competitive landscape.
The
estimated primary completion date has been updated to reflect both
an increase in patient recruitment (as reported in February 2016
with the inclusion of OS as a co-primary endpoint) and the
event-based nature of the trial. As a result, the Company
anticipates MYSTIC PFS data in mid-2017 and final OS data at the
latest in 2018. MYSTIC also includes several undisclosed interim
analyses for OS.
Additionally, the
ongoing Phase III NEPTUNE
trial will be expanded with local patients to support regulatory
submission of durva + treme combination therapy in China for
1st-line NSCLC patients without delaying the anticipated OS data
readout in 2018 from the global cohort, which is approaching full
recruitment. The Company has also initiated the new Phase III PEARL
trial of durvalumab monotherapy versus SoC chemotherapy in 1st-line
NSCLC patients whose tumours express PD-L1. The PEARL trial focuses on Asian countries,
primarily China, due to the high prevalence of NSCLC in the
region.
All
amendments will be reflected in updates to clinical trials
websites, including clinicaltrials.gov.
Sean
Bohen, Executive Vice President, Global Medicines Development and
Chief Medical Officer at AstraZeneca, said: "The MYSTIC trial
amendments, the NEPTUNE trial expansion and initiation of the new
PEARL trial are all designed to enhance our options in 1st-line
NSCLC for IO-IO combination as well as for IO monotherapy. We
continue to follow the science through both internal and external
sources for the benefit of patients and look forward to sharing our
first pivotal data in mid-2017."
About
MYSTIC
The
MYSTIC trial is a randomised, open-label, multi-centre, global,
Phase III trial of durvalumab in combination with tremelimumab or
durvalumab monotherapy versus SoC platinum-based chemotherapy in
1st-line treatment of patients with epidermal growth factor
receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type
advanced or metastatic NSCLC.
About
NEPTUNE
The
NEPTUNE trial is randomised, open-label, multi-centre, global,
Phase III trial of durvalumab in combination with tremelimumab
versus SoC platinum-based chemotherapy in 1st-line treatment of
patients with epidermal growth factor receptor (EGFR) and
anaplastic lymphoma kinase (ALK) wild-type advanced or metastatic
NSCLC.
About
PEARL
The
PEARL trial is a randomised, open-label, multi-centre Phase III
trial of durvalumab monotherapy versus SoC chemotherapy in 1st-line
treatment of patients with epidermal growth factor receptor (EGFR)
and anaplastic lymphoma kinase (ALK) wild-type advanced or
metastatic PDL1-expressing NSCLC. The trial was initiated to
determine the efficacy and safety of durvalumab in Asian countries,
some of which have the highest current NSCLC burden, with over 1.1
million new cases projected for China alone in 2030.
About
Durvalumab
Durvalumab is an
investigational human monoclonal antibody directed against
programmed death ligand-1 (PD-L1). PD-L1 expression enables tumours
to evade detection from the immune system through binding to PD-1
on cytotoxic T lymphocytes. Durvalumab blocks PD-L1 interaction
with both PD-1 and CD80 on T cells, countering the tumour's immune-
evading tactics and activating the patient's immune system to
attack the cancer. Durvalumab received FDA Breakthrough Therapy
Designation in patients with PD-L1 positive inoperable or
metastatic UC in 2016 and Fast Track Designation in 2015 for the
treatment of patients with PD-L1 positive metastatic head and neck
squamous cell carcinoma. The durvalumab biological license
application (BLA) in second-line urothelial carcinoma (UC) has been
accepted by the FDA with a PDUFA date in the second quarter of
2017.
AstraZeneca's
Approach to Immuno-Oncology (IO)
IO is a
therapeutic approach designed to stimulate the body's immune system
to destroy 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 vast
majority of patients.
We are
pursuing a comprehensive clinical trial programme that includes
durvalumab (PD-L1) monotherapy and durvalumab in combination with
tremelimumab (CTLA-4) 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 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 New Oncology as one of AstraZeneca's six Growth
Platforms 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, the genetic drivers of cancer 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 main
therapy areas - Oncology, Cardiovascular & Metabolic Diseases
and Respiratory. The Company also is selectively active in the
areas of autoimmunity, neuroscience and infection. 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.
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Adrian
Kemp
Company
Secretary, AstraZeneca PLC
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.
AstraZeneca
PLC
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Date:
17 January 2017
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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