FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of May 2017
Commission
File Number: 001-11960
AstraZeneca PLC
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This announcement contains inside information
01
May 2017 18:15 BST
ASTRAZENECA'S
IMFINZI (DURVALUMAB) RECEIVES US FDA ACCELERATED APPROVAL FOR
PREVIOUSLY TREATED PATIENTS WITH ADVANCED BLADDER
CANCER
Approval granted
regardless of PD-L1 status, based on tumour response rate and duration of
response
Imfinzi is the cornerstone in an extensive
Immuno-Oncology
programme across multiple cancer
types and stages of disease
AstraZeneca
and its global biologics research and development arm, MedImmune,
today announced that the US Food and Drug Administration (FDA) has
granted accelerated approval to Imfinzi (durvalumab). Imfinzi is indicated for the treatment
of patients with locally advanced or metastatic urothelial
carcinoma (mUC) 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. Imfinzi is approved under the FDA's
accelerated approval pathway, based on tumour response rate and
durability of response. Continued approval for this indication may
be contingent upon verification and description of clinical benefit
in confirmatory trials.
Pascal
Soriot, Chief Executive Officer of AstraZeneca, said: "We are
excited to offer Imfinzi as
a breakthrough therapy for patients with locally-advanced or
metastatic bladder cancer. Imfinzi is the cornerstone of our
extensive Immuno-Oncology programme, in development across many
tumour types, as monotherapy and in combination. This first
approval for Imfinzi is an important milestone
in our return to growth and brings us another step closer to our
goal of redefining the way cancer is treated."
Imfinzi is also under investigation in the Phase III DANUBE
trial as 1st- line treatment in urothelial carcinoma as monotherapy
and in combination with tremelimumab.
Nicholas
J. Vogelzang, MD, FACP, FASCO, Clinical Professor at the University
of Nevada School of Medicine; SWOG GU Vice Chair; US Oncology
Research GU Chair; Comprehensive Cancer Centers of Nevada, said:
"The usual course of treatment for patients with advanced bladder
cancer begins with a standard platinum-containing chemotherapy.
Patients who have disease progression during or following
chemotherapy are left with few other treatment options. The
approval of Imfinzi to
treat this population of select patients signifies hope for those
who are currently suffering, or may find themselves with limited
options in the future."
The
recommended dose of Imfinzi
is 10 mg/kg body weight administered as an intravenous infusion
over 60 minutes every two weeks until disease progression or
unacceptable toxicity.
The
accelerated FDA approval of Imfinzi, a human monoclonal antibody
that blocks PD-L1, is based on data from Study 1108. This Phase
I/II trial evaluated the safety and efficacy of Imfinzi in patients with
locally-advanced or metastatic urothelial carcinoma of the bladder.
Patients had progressed while on or after a platinum-containing
chemotherapy, including those who progressed within 12 months of
receiving therapy in a neoadjuvant or adjuvant
setting.
In the
trial, Imfinzi demonstrated
rapid and durable responses, with an objective response rate (ORR)
of 17.0% (95% confidence interval [CI]: 11.9; 23.3) in all
evaluable patients, regardless of PD-L1 status, and 26.3% (95% CI:
17.8; 36.4) in patients with PD-L1 high-expressing tumours (as
determined by the VENTANA PD-L1 (SP263) Assay, Ventana Medical
Systems Inc., a member of the Roche Group). PD-L1 high was defined
as ≥25% of tumour cells (TC) or tumour-infiltrating immune
cells (IC) expressing membrane PD-L1 if ICs involved >1% of the
tumour area, or TC≥25% or IC=100% if ICs involved ≤1%
of the tumour area. Additionally, approximately 14.3% of all
evaluable patients achieved partial response and 2.7% achieved
complete response. Of patients who had received only neoadjuvant or
adjuvant therapy prior to trial entry, 24% (n=9) responded. Based
on a secondary endpoint in this single-arm trial, median time to
response was six weeks. Among the total 31 responding patients, 14
patients (45%) had ongoing responses of six months or longer and
five patients (16%) had ongoing responses of 12 months or
longer.
Efficacy results for Study 1 (bladder cancer cohort of Study
1108
|
|
All Patients(N=182)
|
PD-L1
High
(N=95)
|
PD-L1 Low/Negative (N=73)
|
PD-L1 Not Evaluable (N=14)
|
Objective Response Rate (ORR) by BICR*, n (%)
(95% confidence interval [CI])
|
31 (17.0%)(11.9; 23.3)
|
25 (26.3%)
(17.8; 36.4)
|
3 (4.1%)
(0.9; 11.5)
|
3 (21.4%)
(4.7; 50.8)
|
Complete Response
(CR)
|
5
|
3
|
1
|
1
|
Partial
Response (PR)
|
26
|
22
|
2
|
2
|
Median Duration of Response (DoR), months (range)
|
Not reached(0.9+; 19.9+)
|
Not reached
(0.9+; 19.9+)
|
12.3
(1.9+; 12.3)
|
Not reached
(2.3+; 2.6+)
|
*BICR=Blinded
Independent Central Review
+
Denotes a censored value
|
Patients
should be monitored for immune-mediated adverse reactions including
pneumonitis, hepatitis, colitis, endocrinopathies (including
adrenal insufficiency, hypophysitis, or Type 1 diabetes mellitus),
nephritis, rash, thrombocytopenic purpura, infection,
infusion-related reactions, or embryo-fetal toxicity. Serious
adverse reactions occurred in 46% of patients. The most frequent
serious adverse reactions (>2%) were acute kidney injury (4.9%),
urinary tract infection (4.4%), musculoskeletal pain (4.4%), liver
injury (3.3%), general physical health deterioration (3.3%),
sepsis, abdominal pain, and pyrexia/tumour associated fever (2.7%
each). Eight patients (4.4%) who were treated with Imfinzi experienced Grade 5 adverse
events of cardiorespiratory arrest, general physical health
deterioration, sepsis, ileus, pneumonitis, or immune-mediated
hepatitis. Three additional patients were experiencing infection
and disease progression at the time of death. Imfinzi was discontinued for adverse
reactions in 3.3% of patients.
Clinical
trials have demonstrated that patients with PD-L1 high-expressing
tumours have a higher likelihood of response through blockade of
the PD-1/PD-L1 pathway. PD-L1 expression testing may be a useful
tool to help guide physicians in their treatment decisions, but it
is not required for use of Imfinzi.
About Imfinzi
(durvalumab)
Imfinzi (durvalumab, previously known as MEDI4736) is a
human monoclonal antibody directed against PD-L1, which blocks the
interaction of PD-L1 with PD-1 and CD80.
Durvalumab
is also being tested in the 1st-line treatment of patients with
unresectable and metastatic bladder cancer as a monotherapy and in
combination with tremelimumab, a checkpoint inhibitor that targets
CTLA-4, as part of the DANUBE Phase III trial, which had the last
patient commenced dosing during the first quarter of 2017 (global
trial, excluding China). Additional clinical trials are ongoing to
investigate durvalumab as monotherapy or in combination in multiple
solid tumours and blood cancers.
About bladder cancer
Urothelial
bladder cancers arise from the epithelium of the bladder and are
the ninth most common form of cancer worldwide. It is estimated
that in 2016, about 430,000 people were diagnosed with bladder
cancer around the world and 165,000 did not survive. Metastatic
bladder cancer remains an area of unmet medical need in particular;
among patients treated with standard-of-care chemotherapy, the
five-year survival rate is below 15%.
The
tumour microenvironment of urothelial carcinoma (UC) significantly
impairs lymphocyte function, helping the cancer to evade immune
detection by exploiting inhibitory checkpoint pathways, such as
PD-L1/PD-1. PD-L1 is widely expressed in tumour and immune
cells in UC patients and helps tumours to evade detection from the
immune system through binding to the PD-1 receptor on cytotoxic T
lymphocytes.
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 program that includes
durvalumab (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 majority 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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Adrian Kemp
Company Secretary, AstraZeneca PLC
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
AstraZeneca
PLC
Date:
02 May 2017
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
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