TIDMAZN
RNS Number : 3386H
AstraZeneca PLC
12 March 2018
12 March 2018 07:00 GMT
ASTRAZENECA PROVIDES UPDATE ON MYSTIC TRIAL TIMELINE
AstraZeneca and MedImmune, its global biologics research and
development arm, today announced an updated timeline for the final
analysis of the Phase III MYSTIC trial of Imfinzi (durvalumab) as
monotherapy and in combination with tremelimumab, versus
platinum-based standard-of-care (SoC) chemotherapy in
previously-untreated patients with metastatic (Stage IV) 1st-line
non-small cell lung cancer (NSCLC).
MYSTIC is an event-driven clinical trial and continues per
protocol. Based on current predictions, the final analysis of
overall survival (OS) is now expected in the second half of 2018
(previously anticipated in the first half).
About MYSTIC
The MYSTIC trial is a randomised, open-label, multi-centre,
global Phase III trial of Imfinzi monotherapy or Imfinzi in
combination with tremelimumab versus SoC in treatment of patients
with epidermal growth factor receptor (EGFR) and anaplastic
lymphoma kinase (ALK) wild-type locally-advanced or metastatic
(Stage IV) 1st-line NSCLC.
The trial is being conducted in 167 centres across 17 countries,
including the US, Canada, Europe, Russia, Australia and parts of
Asia including Japan, Korea, Thailand, Taiwan and Vietnam. Primary
endpoints include progression-free survival (in combination), which
read out in July 2017, and OS in monotherapy and in
combination.
About Imfinzi
Imfinzi 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.
In February 2018, Imfinzi received US FDA approval for the
treatment of patients with unresectable Stage III NSCLC whose
disease has not progressed following concurrent platinum-based
chemotherapy and radiation therapy. Imfinzi has also received
accelerated approval in the US for the treatment of patients with
locally advanced or metastatic urothelial carcinoma, who have
disease progression during or following platinum-containing
chemotherapy, or whose disease has progressed within 12 months of
receiving platinum-containing chemotherapy before (neoadjuvant) or
after (adjuvant) surgery.
As part of a broad development programme, Imfinzi is also being
investigated as a monotherapy and/or in combination with
tremelimumab, an anti-CTLA-4 monoclonal antibody and potential new
medicine, as a first line treatment for patients with NSCLC, small
cell lung cancer, locally-advanced or metastatic urothelial
carcinoma, head and neck cancer and other solid tumours.
About tremelimumab
Tremelimumab is an investigational human monoclonal antibody
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 investigated in an extensive
clinical trial programme in combination with Imfinzi, in NSCLC,
locally-advanced or metastatic urothelial carcinoma, head and neck
cancer, liver cancer and blood cancers.
About AstraZeneca in NSCLC
Lung cancer is the leading cause of cancer death among both men
and women, accounting for about one-third of all cancer deaths and
more than breast, prostate and colorectal cancers combined.
AstraZeneca has a comprehensive portfolio of approved and
potential new medicines in late-stage clinical development for the
treatment of NSCLC across all stages of disease and lines of
therapy. We aim to address 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 and Tagrisso
and ongoing FLAURA and ADAURA trials. Our extensive late-stage
immuno-oncology programme focuses on 75-80% of patients with NSCLC
without a known genetic mutation. Our portfolio includes Imfinzi,
an anti-PDL1 antibody, which is in development as monotherapy
(ADJUVANT, PACIFIC, MYSTIC, PEARL and ARCTIC trials) and in
combination with tremelimumab (MYSTIC, NEPTUNE and POSEIDON
trials).
About AstraZeneca's Approach to Immuno-Oncology
Immuno-Oncology (IO) is a therapeutic approach designed to
stimulate the body's immune system to attack 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 clear majority of patients.
We are pursuing a comprehensive clinical-trial programme that
includes Imfinzi (anti-PD-L1) as monotherapy and in combination
with tremelimumab (anti-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 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 growth platform 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 MedImmune
MedImmune is the global biologics research and development arm
of AstraZeneca, a global, innovation-driven biopharmaceutical
business that focuses on the discovery, development and
commercialisation of small molecule and biologic prescription
medicines. MedImmune is pioneering innovative research and
exploring novel pathways across Oncology; Respiratory,
Cardiovascular & Metabolic Diseases; and Infection and
Vaccines. The MedImmune headquarters is located in Gaithersburg,
US., one of AstraZeneca's three global R&D centres, with
additional sites in Cambridge, UK, and Mountain View, US. 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 commercialisation of
prescription medicines, primarily for the treatment of diseases in
three therapy areas - Oncology, Cardiovascular, Renal &
Metabolism and Respiratory. The Company is also 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.
Media Relations
Esra Erkal-Paler UK/Global +44 203 749 5638
Karen Birmingham UK/Global +44 203 749 5634
Rob Skelding UK/Global +44 203 749 5821
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Craig Marks Finance; Fixed Income; M&A +44 7881 615 764
Henry Wheeler Oncology +44 203 749 5797
Mitchell Chan Oncology; Other +1 240 477 3771
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Adrian Kemp
Company Secretary, AstraZeneca PLC
This information is provided by RNS
The company news service from the London Stock Exchange
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