a5813x
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 September 2020
Commission
File Number: 001-11960
AstraZeneca PLC
1
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Cambridge
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Imfinzi
approved in the EU for the treatment of extensive-stage small cell
lung cancer
1
September 2020 07:00 BST
Imfinzi approved in the EU for the treatment
of
extensive-stage small cell lung cancer
Only PD-1/PD-L1 immunotherapy to demonstrate a
significant survival benefit
and improved response rate in combination with a choice of
chemotherapies
AstraZeneca's Imfinzi (durvalumab) has been approved in the
European Union for the 1st-line treatment of adults with
extensive-stage small cell lung cancer (ES-SCLC) in combination
with a choice of chemotherapies, etoposide plus either carboplatin
or cisplatin.
SCLC is a highly aggressive, fast-growing form of lung cancer that
typically recurs and progresses rapidly despite initial response to
chemotherapy.1,2
The approval by the European Commission was based on
positive results from the Phase III CASPIAN trial
showing Imfinzi plus chemotherapy demonstrated a
statistically significant and clinically meaningful overall
survival (OS) benefit for the 1st-line treatment of patients with
ES-SCLC. It follows
the recommendation
for approval by the Committee
for Medicinal Products for Human Use of the European Medicines
Agency in July 2020.
Luis Paz-Ares MD, Ph.D., Chair, Medical Oncology Department,
Hospital Universitario Doce de Octubre, Madrid, Spain and principal
investigator in the Phase III CASPIAN trial said: "For the first
time, patients with extensive-stage small cell lung cancer in
Europe will have the option of an immunotherapy combination with
cisplatin, a preferred chemotherapy for many European physicians in
this setting. Today's approval of Imfinzi provides physicians with an important new
1st-line treatment option that provides significant overall
survival benefit with a well-tolerated
treatment."
Dave Fredrickson, Executive Vice President, Oncology Business Unit,
said: "Imfinzi plus chemotherapy is becoming a new global
standard of care for patients with extensive-stage small cell lung
cancer, and we are pleased to bring this option to patients in
Europe who urgently need it. This is the first immunotherapy
regimen to offer both a sustained survival benefit and an improved
response rate, as well as a choice of chemotherapies and convenient
dosing every four weeks during maintenance."
The CASPIAN trial met the primary endpoint of OS
for Imfinzi plus chemotherapy in June 2019, reducing the
risk of death by 27% versus chemotherapy alone (based on a hazard
ratio [HR] of 0.73; 95% confidence interval [CI] 0.59-0.91;
p=0.0047), with median OS of 13.0 months versus 10.3 months
for chemotherapy alone. These results were published
in The
Lancet in
2019.3 Results
also showed an increased confirmed objective response rate
for Imfinzi plus chemotherapy (68% versus 58% for
chemotherapy alone) and that Imfinzi added to chemotherapy delayed the
time for disease symptoms to worsen.
An updated analysis recently showed sustained
efficacy for Imfinzi plus
chemotherapy after a median follow up of more than two
years (OS HR: 0.75;
95% CI 0.62-0.91; nominal p=0.0032), with median OS of
12.9 months versus 10.5 months for chemotherapy alone. The
safety and tolerability for Imfinzi plus chemotherapy were consistent with the
known safety profile of these medicines. No patients tested
positive for treatment-emergent anti-drug antibodies
to Imfinzi.
The CASPIAN trial used a fixed dose of Imfinzi (1500mg)
administered every three weeks for four cycles while in combination
with chemotherapy and then every four weeks until disease
progression.
Imfinzi in combination
with etoposide and either carboplatin or cisplatin is also approved
in the US, Japan and several other countries for the treatment of
ES-SCLC in the 1st-line setting and is currently under regulatory
review in other countries.
As part of a broad development programme, Imfinzi is also being tested following concurrent
chemoradiation therapy in patients with limited-stage SCLC in the
Phase III ADRIATIC trial.
Small cell lung cancer
Lung cancer is the leading cause of cancer death among both men and
women and accounts for about one fifth of all cancer
deaths.4 Lung
cancer is broadly split into non-small cell lung cancer (NSCLC) and
SCLC, with about 15% classified as SCLC.5 About
two thirds of SCLC patients are diagnosed with ES-SCLC, in which
the cancer has spread widely through the lung or to other parts of
the body.6 Prognosis
is particularly poor, as only 6% of all SCLC patients will be alive
five years after diagnosis.6
CASPIAN
CASPIAN was a randomised, open-label, multi-centre, global Phase
III trial in the 1st-line treatment of 805 patients with ES-SCLC.
The trial compared Imfinzi in combination with etoposide and either
carboplatin or cisplatin chemotherapy, or Imfinzi and chemotherapy with the addition of a
second immunotherapy, tremelimumab, versus chemotherapy alone. In
the experimental arms, patients were treated with four cycles of
chemotherapy. In comparison, the control arm allowed up to six
cycles of chemotherapy and optional prophylactic cranial
irradiation. The trial was conducted in more than 200 centres
across 23 countries, including the US, in Europe, South America,
Asia and the Middle East. The primary endpoint was OS in each of
the two experimental arms. In June 2019, AstraZeneca announced the
CASPIAN trial had met one primary endpoint of demonstrating OS
for Imfinzi plus chemotherapy at a planned interim
analysis. In March 2020, it was announced that the second
experimental arm with tremelimumab did not meet its primary
endpoint of OS.
Imfinzi
Imfinzi is 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 is approved in the
curative-intent setting of unresectable, Stage III NSCLC after
chemoradiation therapy in the US, Japan, China, across the EU and
in many other countries, based on results from Phase III PACIFIC
trial. Imfinzi is also approved for previously treated
patients with advanced bladder cancer in the US and a small number
of other countries.
As part of a broad development programme, Imfinzi is also being tested as a monotherapy and in
combinations including with tremelimumab, an anti-CTLA4 monoclonal
antibody and potential new medicine, as a treatment for patients
with NSCLC, SCLC, bladder cancer, head and neck cancer, liver
cancer, biliary tract cancer, cervical cancer, ovarian cancer,
endometrial cancer and other solid tumours.
AstraZeneca in lung cancer
AstraZeneca has a comprehensive portfolio of approved and potential
new medicines in late-stage development for the treatment of
different forms of lung cancer spanning different histologies,
several stages of disease, lines of therapy and modes of
action.
An extensive Immuno-Oncology (IO) development programme focuses on
lung cancer patients without a targetable genetic mutation, which
represent up to three quarters of all patients with lung
cancer.7 Imfinzi,
an anti-PDL1 antibody, is in development for patients with advanced
disease (Phase III trials POSEIDON and PEARL) and for patients in
earlier stages of disease, including potentially-curative settings
(Phase III trials MERMAID-1, AEGEAN, ADJUVANT BR.31, PACIFIC-2,
PACIFIC-4, PACIFIC-5, and ADRIATIC) both as monotherapy and in
combination with tremelimumab and/or
chemotherapy. Imfinzi is also in development in the Phase II
trials NeoCOAST, COAST and HUDSON in combination with potential new
medicines from the early-stage pipeline,
including Enhertu.
AstraZeneca's approach to IO
IO is a therapeutic approach designed to stimulate the body's
immune system to attack tumours. The Company's IO portfolio is
anchored by immunotherapies that have been designed to overcome
anti-tumour immune suppression. AstraZeneca is invested in using IO
approaches that deliver long-term survival for new groups of
patients across tumour types.
The Company is pursuing a comprehensive clinical-trial programme
that includes Imfinzi as a monotherapy and in combination with
tremelimumab in multiple tumour types, stages of disease, and lines
of therapy, and where relevant 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 the IO portfolio
with radiation, chemotherapy, small targeted molecules from across
AstraZeneca's Oncology pipeline, and from research partners, may
provide new treatment options across a broad range of
tumours.
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 seven
new medicines launched between 2014 and 2020, and a broad pipeline
of small molecules and biologics in development, the Company is
committed to advance oncology as a key growth driver for
AstraZeneca focused on lung, ovarian, breast and blood
cancers.
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.
AstraZeneca
AstraZeneca (LSE/STO/NYSE: AZN) 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, Renal & Metabolism, and Respiratory
& Immunology. Based in Cambridge, UK, AstraZeneca operates in
over 100 countries and its innovative medicines are used by
millions of patients worldwide. Please
visit astrazeneca.com and
follow the Company on Twitter @AstraZeneca.
Contacts
For details on how to contact the Investor Relations Team, please
click here.
For Media contacts, click here.
References
1. National Cancer Institute. NCI Dictionary - Small Cell Lung
Cancer. Available at https://www.cancer.gov/publications/dictionaries/cancer-terms/def/small-cell-lung-cancer.
Accessed July 2020.
2. Kalemkerian GP, et al. Treatment Options for Relapsed Small-Cell Lung
Cancer: What Progress Have We Made? Journal of Oncology
Practice,
2018:14;369-370.
3. Paz-Ares L, et al. Durvalumab plus platinum-etoposide versus
platinum-etoposide in first-line treatment of extensive-stage
small-cell lung cancer (CASPIAN): a randomised, controlled,
open-label, phase 3 trial. The Lancet.
2019;394(10212):1929-1939.
4. World Health Organization. International Agency for Research on
Cancer. Lung Fact Sheet. Available at http://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf.
Accessed July 2020.
5. LUNGevity Foundation. Types of Lung Cancer. Available
at https://lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer.
Accessed July 2020.
6. Cancer.Net. Lung Cancer - Small Cell. Available
at https://www.cancer.net/cancer-types/33776/view-all.
Accessed July 2020.
7. Pakkala, S, et al. Personalized therapy for lung cancer:
striking a moving target. JCI Insight. 2018;3(15):e120858.
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.
Date:
01 September 2020
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By: /s/
Adrian Kemp
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|
Name:
Adrian Kemp
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|
Title:
Company Secretary
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