TIDMAZN
RNS Number : 3289U
AstraZeneca PLC
17 January 2017
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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This information is provided by RNS
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