TIDMAZN
RNS Number : 7988D
AstraZeneca PLC
01 May 2017
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 PD-L1 PD-L1 Low/Negative PD-L1 Not
(N=182) High (N=73) Evaluable (N=14)
(N=95)
----------------------------------------- ---------------- --------------- ------------------- -------------------
Objective Response Rate (ORR) by BICR*, 31 (17.0%) 25 (26.3%) 3 (4.1%) 3 (21.4%)
n (%)
(95% confidence interval [CI]) (11.9; 23.3) (17.8; 36.4) (0.9; 11.5) (4.7; 50.8)
----------------------------------------- ---------------- --------------- ------------------- -------------------
Complete Response (CR) 5 3 1 1
----------------------------------------- ---------------- --------------- ------------------- -------------------
Partial Response (PR) 26 22 2 2
----------------------------------------- ---------------- --------------- ------------------- -------------------
Median Duration of Response (DoR), mont Not reached Not reached 12.3 Not reached
hs (range)
(0.9+; 19.9+) (0.9+; 19.9+) (1.9+; 12.3) (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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