TIDMAZN
RNS Number : 3068Q
AstraZeneca PLC
11 September 2017
11 September 2017 07:00 BST
ASTRAZENECA PRESENTS SUPERIOR PROGRESSION-FREE SURVIVAL FOR
IMFINZI IN THE PACIFIC TRIAL OF PATIENTS WITH LOCALLY-ADVANCED
UNRESECTABLE LUNG CANCER AT ESMO 2017 CONGRESS
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.
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
(median)
(first primary 95% CI, 0.42-0.65,
endpoint) p<0.0001
------------------- --------- ------------ ---------------------
Placebo 5.6 months
(median)
------------------- --------- ------------ ---------------------
Duration of Imfinzi Not reached N/A
response (DoR)
------------------- --------- ------------ ---------------------
Placebo 13.8 months
------------------- --------- ------------ ---------------------
Objective Imfinzi 28.4% 95% CI, 24.28-32.89,
Response Rate p<0.001
(ORR) as measured
from baseline
scan post-CRT
completion
------------------- --------- ------------ ---------------------
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 completion of
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.
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.
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.
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