TIDMAZN
RNS Number : 2013F
AstraZeneca PLC
19 February 2018
This announcement contains inside information
19 February 2018 07:00 GMT
US FDA APPROVES IMFINZI FOR UNRESECTABLE STAGE III NON-SMALL
CELL LUNG CANCER
Imfinzi is the only immunotherapy approved for patients with
unresectable Stage III non-small cell lung cancer
Imfinzi showed an 11.2 month improvement in median
progression-free survival (16.8 months compared to 5.6 months on
placebo)
AstraZeneca and MedImmune, its global biologics research and
development arm, today announced that the US Food and Drug
Administration (FDA) has approved Imfinzi for the treatment of
patients with unresectable Stage III non-small cell lung cancer
(NSCLC) whose disease has not progressed following concurrent
platinum-based chemotherapy and radiation therapy (CRT).
Dave Fredrickson, Executive Vice President, Head of the Oncology
Business Unit at AstraZeneca, said: "The approval of Imfinzi in
this earlier stage of non-small cell lung cancer is a truly
meaningful milestone for patients who, until now, had no
FDA-approved treatment options following chemoradiation therapy.
Globally, approximately 30% of patients with NSCLC present with
Stage III disease and we are excited to launch the first
immunotherapy into this setting."
Scott J. Antonia, MD, Ph.D., Chair of the Thoracic Oncology
Department at the H. Lee Moffitt Cancer Center and Research
Institute in Tampa and investigator in the PACIFIC trial, said:
"Until now, treatment guidelines have recommended that patients
with unresectable Stage III lung cancer undergo a period of active
surveillance following chemoradiation therapy until disease
progression. Given that up to 89% of patients will progress to
metastatic disease, it is important that there is now a new option
that can give patients more time without disease progression. The
PACIFIC trial data supporting today's approval of Imfinzi will
change how we treat these patients."
The approval of Imfinzi is based on the positive PFS data from
the Phase III PACIFIC trial
in which Imfinzi demonstrated an improvement in median PFS of
11.2 months compared to placebo, representing a 48% reduction in
relative risk of progression or death vs. placebo in all patients,
regardless of PD-L1 status. The PACIFIC trial is ongoing to
evaluate overall survival (OS) in unresectable Stage III NSCLC.
Detailed interim results of the PACIFIC trial were published online
in the New England Journal of Medicine (NEJM).
PFS (co-primary endpoint)(1) Imfinzi Placebo
(N=476)(2) (N=237)(2)
================================== =========== ===========
Number (%) of patients with event 214 (45%) 157 (66%)
================================== =========== ===========
Median in months 16.8 5.6
(95% CI) (13, 18.1) (4.6, 7.8)
================================== =========== ===========
Hazard Ratio 0.52 (0.42, 0.65)
(95% CI)(3, 4)
================================== ========================
p-value(3, 5) <0.0001
================================== ========================
(1) Blinded Independent Central Review (BICR)
(2) Among the ITT population, 7% in the IMFINZI arm and 10% in
the placebo arm had non-measurable disease as assessed by BICR
according to RECIST v1.1
(3) Stratified by sex, age, and smoking history
(4) Pike estimator
(5) Compared with allocated <ALPHA> of 0.0104 (Lan DeMets
spending function approximating O'Brien Fleming boundary) for
interim analysis
Overall, the incidence and severity of adverse events were
comparable for patients receiving Imfinzi and the patients
receiving placebo. In patients receiving Imfinzi, the most common
adverse reactions (greater than or equal to 20% of patients) were
cough (40%), fatigue (34%), pneumonitis or radiation pneumonitis
(34%), upper respiratory tract infections (26%), dyspnoea (25%),
and rash (23%). Discontinuation after concurrent CRT due to adverse
reactions, regardless of causality, occurred in 15% of patients
receiving Imfinzi vs. 10% of patients receiving placebo.
On 28 September 2017, the National Comprehensive Cancer Network
(NCCN) Clinical Practice Guidelines in Oncology were updated to
include Imfinzi for the treatment of patients with unresectable
Stage III NSCLC with no disease progression after two or more
cycles of concurrent CRT.
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
France, Germany, Italy, Japan, Spain, the UK and the US in 2016.
The majority of Stage III NSCLC patients are diagnosed with
unresectable tumours. Until now, the current standard of care has
been chemotherapy and radiation therapy, followed by active
surveillance to monitor for progression. The prognosis remains poor
and long-term survival rates are low.
About Imfinzi
Imfinzi (durvalumab), 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.
Imfinzi has already received accelerated approval in the US for
the treatment of patients with locally-advanced or metastatic
urothelial carcinoma, 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.
As part of a broad development programme, Imfinzi is also being
investigated for the adjuvant treatment of patients with NSCLC in
the Canadian Cancer Trials Group BR31 trial (ADJUVANT). In the
MYSTIC, NEPTUNE and PEARL Phase III trials, Imfinzi is being
studied for 1st-line treatment as monotherapy and/or in combination
with tremelimumab, an anti-CTLA-4 monoclonal antibody and potential
new medicine, for the treatment of metastatic NSCLC. The POSEIDON
trial is investigating Imfinzi with and without tremelimumab in
combination with chemotherapy in a similar patient population.
About AstraZeneca in Lung Cancer
AstraZeneca is committed to developing medicines to help every
patient with lung cancer. We have three approved medicines 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
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 durvalumab (anti-PD-L1) as 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 Oncology as a growth platform 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 & 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 & 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
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