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2018-07-27

AstraZeneca: Imfinzi receives positive EU CHMP opinion for locally- advanced, unresectable non-small cell lung cancer

Recommended marketing authorisation for patients whose tumours express
PD-L1 on ?1% of tumour cells

Imfinzi is the first immunotherapy recommended for approval for the
treatment of locally-advanced, unresectable NSCLC

AstraZeneca and MedImmune, its global biologics research and
development arm, today announced that the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency has
adopted a positive opinion, recommending a marketing authorisation of
Imfinzi (durvalumab) for the treatment of locally-advanced,
unresectable non-small cell lung cancer (NSCLC) in adults whose
tumours express PD-L1 on ?1% of tumour cells and whose disease has
not progressed following platinum-based chemotherapy and radiation
therapy (CRT). The recommendation is based on the progression-free
survival (PFS) and overall survival (OS) primary endpoints of the
Phase III PACIFIC trial, and post-hoc subgroup analyses by PD-L1
expression requested by the CHMP.

Sean Bohen, Executive Vice President, Global Medicines Development and
Chief Medical Officer at AstraZeneca, said: "The CHMP positive
opinion brings European patients closer to having a treatment
following chemoradiation therapy. There have been no new treatments
in this setting for decades. With approximately a third of European
non-small cell lung cancer patients presenting with this stage of
disease, we are excited by this potential new standard of care in
this curative-intent setting."

In the PACIFIC trial, Imfinzi demonstrated a statistically-significant
and clinically-meaningful improvement in PFS and OS in "all-comer"
patients. The recommended label reflects most of the patients in the
trial with a known PD-L1 status.

Overall survival results from the PACIFIC trial will be presented at a
forthcoming medical meeting.

The positive opinion from the CHMP will now be reviewed by the
European Commission, which has the authority to approve medicines for
the 28 European Union member countries plus Iceland, Norway and
Liechtenstein. Earlier this year, Imfinzi was approved for
unresectable, Stage III NSCLC in the US, Canada, Switzerland, India,
Japan and Brazil based on the Phase III PACIFIC trial. In addition to
the EU, other global health authority reviews and submissions are
ongoing.

About Stage III NSCLC

Stage III (locally advanced) NSCLC is commonly divided into three
sub-categories (IIIA, IIIB and IIIC), defined by how much the cancer
has spread locally and the possibility of surgery. Stage III disease
is different from Stage IV disease, when the cancer has spread
(metastasised) to distant organs, as Stage III is currently treated
with curative intent.

Stage III NSCLC represents approximately one-third of NSCLC incidence
and was estimated to affect around 105,000 patients in the top-eight
countries (China, France, Germany, Italy, Japan, Spain, UK, US) in
2017. The majority of Stage III NSCLC patients are diagnosed with
unresectable tumours. No new treatments beyond chemoradiation
therapy, followed by active surveillance to monitor for progression,
have been available to patients for decades.

About PACIFIC

The PACIFIC trial is a randomised, double-blinded, placebo-controlled,
multi-centre trial of Imfinzi as treatment in `all-comer' patients
(i.e. regardless of PD-L1 status) with unresectable, Stage III NSCLC
whose disease has not progressed following platinum-based
chemotherapy and radiation therapy (CRT).

The trial is being conducted in 235 centres across 26 countries
involving 713 patients. The primary endpoints of the trial are PFS
and OS, and secondary endpoints include landmark PFS and OS,
objective response rate, and duration of response.

About 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,
countering the tumour's immune-evading tactics and releasing the
inhibition of immune responses.

Imfinzi is approved for unresectable, Stage III NSCLC in the US,
Canada, Switzerland, India, and Japan based on the Phase III PACIFIC
trial.

As part of a broad development programme, Imfinzi is also being tested
as a monotherapy and in combination with chemotherapy, radiation
therapy, small molecules, and tremelimumab, an anti-CTLA4 monoclonal
antibody, as a first or second-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 AstraZeneca in Lung Cancer

Lung cancer is the leading cause of cancer death among both men and
women, accounting for about one-third of all cancer deaths.

AstraZeneca has a comprehensive portfolio of approved and potential
new medicines in late-stage clinical development for the treatment of
different forms of lung cancer across all stages of disease and lines
of therapy. We aim to address the 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, ADAURA and LAURA Phase III trials. Our extensive
late-stage immuno-oncology programme focuses on 75-80% of patients
with lung cancer without a known genetic mutation. The portfolio
includes Imfinzi, an anti-PDL1 antibody, which is in development as
monotherapy (ADJUVANT BR.31, PACIFIC2, MYSTIC and PEARL Phase III
trials) and in combination with tremelimumab and/or chemotherapy
(MYSTIC, NEPTUNE, POSEIDON and CASPIAN Phase III trials).

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 clear majority of patients.

We are pursuing a comprehensive clinical trial programme that includes
Imfinzi (anti-PDL1) as monotherapy and in combination with
tremelimumab (anti-CTLA4) 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 advancing Oncology as a growth driver 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, Renal & 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 therapy areas - Oncology, Cardiovascular, Renal & Metabolism
and Respiratory. 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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