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2018-05-25

AstraZeneca: Imfinzi significantly improves overall survival in the Phase III PACIFIC trial for unresectable Stage III non-...

Imfinzi met the second primary endpoint of overall survival which was
both statistically-significant and clinically-meaningful at a planned
interim analysis

AstraZeneca and MedImmune, its global biologics research and
development arm, today announced positive overall survival (OS)
results for the Phase III PACIFIC trial, a randomised,
double-blinded, placebo-controlled, multi-centre trial of Imfinzi
(durvalumab) in patients with unresectable Stage III non-small cell
lung cancer (NSCLC) whose disease had not progressed following
platinum-based chemotherapy concurrent with radiation therapy (CRT).

A planned interim analysis conducted by an Independent Data Monitoring
Committee concluded that the trial has met its second of two primary
endpoints by showing statistically-significant OS benefit with
clinically-meaningful improvement in patients receiving Imfinzi
compared to placebo. The safety and tolerability profile for Imfinzi
was consistent with that reported at the time of the progression-free
survival (PFS) analysis. AstraZeneca plans to present results from
the PACIFIC trial at a forthcoming medical meeting.

Sean Bohen, Executive Vice President, Global Medicines Development and
Chief Medical Officer at AstraZeneca, said: "The readout of positive
overall survival data at the interim analysis of the PACIFIC trial
provides additional compelling evidence of the clinical benefit that
Imfinzi can offer patients in this earlier stage of lung cancer. We
look forward to sharing these results with Health Authorities to
support ongoing regulatory interactions and to update the Imfinzi
label with these important data."

In May 2017, AstraZeneca announced that the PACIFIC trial met its
first primary endpoint of PFS by demonstrating a median improvement
of 11.2 months vs. placebo, as assessed by blinded independent
central review.

Imfinzi is currently approved in the US and Canada for the treatment
of patients with unresectable Stage III NSCLC who had not progressed
following platinum-based chemoradiation therapy and under regulatory
review in the EU, Japan and other jurisdictions with expected
decisions in the second half of 2018.

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. This
differentiates it from Stage IV disease, when the cancer has spread
(metastasised) to distant organs.

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. Before the PACIFIC trial, the standard of care
was chemotherapy and radiation therapy, followed by active
surveillance to monitor for progression.

About PACIFIC

The PACIFIC trial is a randomised, double-blinded, placebo-controlled,
multi-centre trial of Imfinzi as treatment in patients with Stage III
unresectable NSCLC whose disease has not progressed following
platinum-based chemoradiation 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, overall
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.

Earlier this month, Imfinzi received approval in Canada for the
treatment of patients with unresectable Stage III NSCLC following
chemoradiation therapy (CRT). In February 2018, Imfinzi received
regulatory approval from the US FDA for the treatment of patients
with unresectable Stage III NSCLC who had not progressed following
concurrent platinum-based CRT.

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-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, MYSTIC and PEARL trials) and in
combination with tremelimumab and/or chemotherapy (MYSTIC, NEPTUNE,
CASPIAN, and POSEIDON 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. 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
Karen Birmingham UK/Global +44 203 749 5634
Rob Skelding UK/Global +44 203 749 5821
Matt Kent UK/Global +44 203 749 5906
Gonzalo Viña UK/Global +44 203 749 5916
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Michele Meixell US +1 302 885 2677

Investor Relations
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Craig Marks Finance; Fixed Income; M&A +44 7881 615 764
Henry Wheeler Oncology +44 203 749 5797
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US toll free +1 866 381 7277

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