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2017-09-09

AstraZeneca: AstraZeneca presents superior progression-free survival for Imfinzi in the PACIFIC trial of patients with loc...

Imfinzi improves progression-free survival (PFS) by more than 11
months compared to standard of care and is the first medicine to show
superior PFS in this setting

Data presented at the ESMO 2017 Congress follows FDA's recent
Breakthrough Therapy Designation for Imfinzi in locally advanced,
unresectable lung cancer

The PACIFIC trial continues to evaluate the other primary endpoint,
overall survival

AstraZeneca and MedImmune, its global biologics research and
development arm, have presented the full PFS data from a planned
interim analysis of the Phase III PACIFIC trial. Results show that
Imfinzi (durvalumab) demonstrated a statistically-significant and
clinically-meaningful improvement in PFS compared to current standard
of care with active surveillance in patients with locally-advanced
(Stage III), unresectable non-small cell lung cancer (NSCLC) who had
not progressed following standard platinum-based chemotherapy
concurrent with radiation therapy (CRT).

Results of the Phase III PACIFIC trial, included at the Presidential
Symposium I of the European Society of Medical Oncology (ESMO) 2017
Congress in Madrid, Spain, show an improvement in PFS of more than 11
months in patients treated with Imfinzi compared to placebo (full
details in table below). The PFS improvement with Imfinzi was
observed across all pre-specified subgroups, including PD-L1
expression status. Patients receiving Imfinzi also had a lower
incidence of metastases than those receiving placebo. The PACIFIC
trial continues to evaluate overall survival (OS), the other primary
endpoint. Detailed results of the PACIFIC trial are published online
in the New England Journal of Medicine
(http://www.nejm.org/doi/full/10.1056/NEJMoa1709937).

Sean Bohen, Executive Vice President, Global Medicines Development and
Chief Medical Officer at AstraZeneca, said: "The Phase III PACIFIC
results are incredibly encouraging for a patient population that
until now has been without treatment options. As the first
Immuno-Oncology medicine to achieve improvement in progression-free
survival in this setting, Imfinzi is showing clear potential to
become a new standard of care for patients with locally-advanced,
unresectable NSCLC who have not progressed following chemoradiation."

Dr. Luis Paz-Ares, Principal Investigator of the PACIFIC trial, from
the Hospital Universitario Doce de Octubre, Madrid, Spain, said: "For
patients with locally-advanced unresectable NSCLC who have completed
chemoradiation therapy, Imfinzi represents a potential new treatment
option in the context of clear unmet clinical need. Durvalumab
overtly prolongs the period in which the disease is controlled with
reasonable side effects. In addition, it offers hope to increase the
cure rate in this setting, but more mature follow-up is needed to
assess its impact on survival."

Summary of key efficacy results:

+------------------------------------+--------+-------------+-------------+
|Endpoint |Medicine|Value |Hazard ratio |
| | | |(HR)/ |
| | | |Confidence |
| | | |interval (CI)|
+------------------------------------+--------+-------------+-------------+
|PFS* |Imfinzi |16.8 months |HR 0.52 |
|(first primary endpoint) | |(median) |95% CI, 0.42 |
| | | |-0.65, |
| | | |p<0.0001 |
+------------------------------------+--------+-------------+-------------+
|Placebo |5.6 |
| |months |
| |(median)|
+------------------------------------+--------+-------------+-------------+
|Duration of response (DoR) |Imfinzi |Not reached |N/A |
+------------------------------------+--------+-------------+-------------+
|Placebo |13.8 |
| |months |
+------------------------------------+--------+-------------+-------------+
|Objective Response Rate (ORR) as |Imfinzi |28.4% |95% CI, 24.28|
|measured from baseline scan post-CRT| | |-32.89, |
|completion | | |p<0.001 |
+------------------------------------+--------+-------------+-------------+
|Placebo |16.0% |95% CI, 11.31|
| | |-21.59, |
| | |p<0.001 |
+------------------------------------+--------+-------------+-------------+

* Time from randomisation to the first documented tumour progression,
or death in the absence of progression. Randomisation in the PACIFIC
trial occurred up to 6 weeks after concurrent chemoradiation therapy
(cCRT) and cCRT typically lasted at least 6 weeks. If the PFS had
been measured prior to cCRT, it would add approximately 3 months or
longer to the PFS value for each arm.

Among patients receiving Imfinzi, the most frequent treatment-related
adverse events (AEs) vs. placebo were cough (35.4% vs 25.2%),
pneumonitis/radiation pneumonitis (33.9% vs 24.8%), fatigue (23.8% vs
20.5%), dyspnoea (22.3% vs 23.9%) and diarrhoea (18.3% vs 18.8%).
29.9% of patients experienced a grade 3 or 4 AE vs. 26.1% for
placebo, and 15.4% of patients discontinued treatment due to AEs
compared to 9.8% of patients on placebo.

On 31 July 2017, Imfinzi received Breakthrough Therapy Designation
from the US Food and Drug Administration (FDA) as a potential
treatment for patients with locally advanced, unresectable NSCLC
whose disease has not progressed following platinum-based
chemoradiation therapy.

AstraZeneca is in discussions with global health authorities regarding
regulatory submissions for Imfinzi based on the PACIFIC data. A
status of regulatory submissions is usually provided with the
Company's quarterly results announcement.

Imfinzi received accelerated approval from the US Food and Drug
Administration for previously treated patients with advanced bladder
cancer and is under review in Canada and Australia for similar use.

-ENDS-

Notes to Editors

About Locally Advanced (Stage III) NSCLC

Stage III lung cancer is 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 other organs.

Stage III lung cancer represents approximately one-third of NSCLC
incidence and was estimated to affect around 105,000 patients in the
G7 countries in 2016. More than half 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 sequential 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 continues to be studied in multiple monotherapy trials and
combination trials with tremelimumab and other potential new
medicines in Immuno-Oncology. Imfinzi is being assessed in Phase III
trials as a monotherapy in various stages of NSCLC, in small-cell
lung cancer (SCLC), in metastatic urothelial cancer (mUC) and in head
and neck squamous cell carcinoma (HNSCC). The combination of Imfinzi
and tremelimumab is being assessed in Phase III trials in NSCLC,
SCLC, mUC and HNSCC and in Phase I/II trials in hepatocellular
carcinoma and haematological malignancies.

About AstraZeneca in Lung Cancer

AstraZeneca is committed to developing therapies to help every patient
with lung cancer. We have two approved therapies 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.

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