TIDMAZN
RNS Number : 7316T
AstraZeneca PLC
17 October 2017
17 October 2017 07:00 BST
US FDA ACCEPTS SUPPLEMENTAL BIOLOGICS LICENSE APPLICATION FOR
IMFINZI IN LOCALLY ADVANCED UNRESECTABLE NON-SMALL CELL LUNG
CANCER
Imfinzi granted Priority Review
Acceptance follows FDA's Breakthrough Therapy Designation
AstraZeneca and MedImmune, its global biologics research and
development arm, today announced that the US Food and Drug
Administration (FDA) has accepted a supplemental Biologics License
Application (sBLA) for Imfinzi (durvalumab) for the treatment of
patients with locally advanced (Stage III) unresectable non-small
cell lung cancer (NSCLC) whose disease has not progressed following
platinum-based chemoradiation therapy. The FDA has granted Imfinzi
Priority Review status.
The US FDA sBLA submission acceptance is an important milestone
for Imfinzi in a disease state where patients need better treatment
options and outcomes. Currently, the standard of care for patients
with this earlier stage of lung disease is active monitoring
following concurrent chemoradiation.
The sBLA submission is based on positive progression-free
survival (PFS) data from the Phase III PACIFIC trial. The trial
continues to evaluate overall survival (OS), its other primary
endpoint. Detailed results of the PACIFIC trial, including
additional safety information, were published online in the New
England Journal of Medicine.
On 28 September 2017, the US NCCN Clinical Practice Guidelines
in Oncology (NCCN Guidelines) were updated to include Imfinzi for
the treatment of patients with locally-advanced unresectable NSCLC
with no disease progression after two or more cycles of definitive
chemoradiation, based on the data from the PACIFIC Phase III trial.
This indication is not yet FDA-approved.
About Locally Advanced (Stage III) NSCLC
Locally advanced (Stage III) lung cancer is commonly divided
into two stages (IIIA and IIIB), which are defined by how much the
cancer has spread locally and the possibility of surgery. This
differentiates it from Stage IV disease, when the cancer has spread
(metastasised) to distant organs.
Stage III lung cancer represents approximately one-third of
NSCLC incidence and was estimated to affect around 105,000 patients
in the top-7 countries in 2016(1) . More than 70% of these patients
have tumours that are unresectable. The current standard of care is
chemotherapy and radiation followed by active surveillance to
monitor for progression. The prognosis remains poor and long-term
survival rates are low.
About PACIFIC
The PACIFIC trial is a randomised, double-blinded,
placebo-controlled, multi-centre trial of Imfinzi as treatment in
unselected patients with locally-advanced, unresectable (Stage III)
NSCLC who have not progressed following platinum-based chemotherapy
concurrent with radiation therapy.
The trial is being conducted in 235 centres across 26 countries
involving approximately 700 patients. The primary endpoints of the
trial are progression-free survival (PFS) and overall survival
(OS), and secondary endpoints include landmark PFS and OS,
objective response rate (ORR) and duration of response.
About Imfinzi
Imfinzi (durvalumab), a human monoclonal antibody directed
against PD-L1, blocks PD-L1 interaction with PD-1 and CD80 on T
cells, countering the tumour's immune-evading tactics and inducing
an immune response.
Imfinzi has already 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 for the adjuvant treatment of patients with NSCLC in
the CCTG (Canadian Cancer Trials Group) trial ADJUVANT (BR31). In
the MYSTIC, NEPTUNE, and PEARL Phase III trials, Imfinzi is being
studied for 1st-line treatment as monotherapy and/or in combination
with tremelimumab, an anti-CTLA-4 monoclonal antibody, for the
treatment of metastatic NSCLC. The POSEIDON trial is investigating
Imfinzi with and without tremelimumab in combination with
chemotherapy in the same population.
About AstraZeneca in Lung Cancer
AstraZeneca is committed to developing medicines to help every
patient with lung cancer. We have two approved medicines and a
growing pipeline that targets genetic changes in tumour cells and
boosts the power of the immune response against cancer. Our
unrelenting pursuit of science aims to deliver more breakthrough
therapies with the goal of extending and improving the lives of
patients across all stages of disease and lines of therapy.
About AstraZeneca's Approach to Immuno-Oncology (IO)
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 vast majority of patients.
We are pursuing a comprehensive clinical trial programme that
includes Imfinzi (anti-PD-L1) 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 New Oncology as one of AstraZeneca's five
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, 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,
Md., one of AstraZeneca's three global R&D centres, with
additional sites in Cambridge, UK, and Mountain View, 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 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.
Media Relations
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Adrian Kemp
Company secretary
AstraZeneca PLC
(1) France, Germany, Italy, Japan, Spain, United Kingdom, United States
This information is provided by RNS
The company news service from the London Stock Exchange
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