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 July 2020
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Imfinzi recommended for EU
approval in SCLC
27 July 2020 07:05 BST
Imfinzi recommended for approval in the EU
by
CHMP for 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 recommended for
marketing authorisation in the European Union (EU) 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 Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency based its positive opinion on results
from the Phase III CASPIAN trial for Imfinzi plus chemotherapy, which have also been
published in The
Lancet.3
The trial showed that Imfinzi plus chemotherapy demonstrated a
statistically significant and clinically meaningful overall
survival (OS) benefit for the 1st-line treatment of patients with
ES-SCLC, 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). Results also showed an
increased confirmed objective response rate in
the Imfinzi plus chemotherapy arm (68% versus 58% for
chemotherapy alone) and that Imfinzi added to chemotherapy delayed the
time it took for lung cancer-related symptoms to
worsen.4
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). 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.
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: "The CASPIAN
trial shows that Imfinzi plus a choice of platinum-etoposide
chemotherapies offers an important new 1st-line treatment option
for extensive-stage small cell lung cancer, providing a sustained
survival benefit with a well-tolerated treatment. For many
physicians in Europe, cisplatin is a preferred chemotherapy in this
setting, and this recommendation is a vital step toward bringing an
immunotherapy combination with cisplatin to these patients in
Europe for the first time."
José Baselga, Executive Vice President, Oncology R&D,
said: "Imfinzi has the potential to address a critical
unmet need for patients with extensive-stage small cell lung cancer
in Europe who have few options to treat this aggressive and
devastating disease. We look forward to delivering a new standard
of care that significantly improves survival with a choice of
chemotherapies and convenient dosing every four weeks during
maintenance."
The CHMP recommendation is for Imfinzi in combination with etoposide and either
carboplatin or cisplatin for the 1st-line treatment of adults with
ES-SCLC. 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 approved in the
US and several other
countries around the world for the treatment of ES-SCLC in the
1st-line setting and is currently under regulatory review in Japan
and other countries.
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.5 Lung
cancer is broadly split into non-small cell lung cancer (NSCLC) and
SCLC, with about 15% classified as SCLC.6 About
two thirds of SCLC patients are diagnosed with extensive-stage
disease, in which the cancer has spread widely through the lung or
to other parts of the body.7 Prognosis
is particularly poor, as only 6% of all SCLC patients will be alive
five years after diagnosis.7
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, the CASPIAN trial met one
primary endpoint of demonstrating OS for Imfinzi plus chemotherapy at a planned interim
analysis. In March 2020, the second experimental arm with
tremelimumab did not meet its primary endpoint of
OS.
Imfinzi
Imfinzi (durvalumab) 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 the 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.
AstraZeneca aims to address the unmet needs of patients with
EGFR-mutated tumours as a genetic driver of disease, which occur in
10-15% of NSCLC patients in the US and EU and 30-40% of NSCLC
patients in Asia, with the approved
medicines Iressa (gefitinib) and Tagrisso (osimertinib) and its ongoing Phase III
trials LAURA, NeoADAURA and FLAURA2.8-10
AstraZeneca is committed to addressing tumour mechanisms of
resistance through the ongoing Phase II trials SAVANNAH and ORCHARD
which test Tagrisso in combination with savolitinib, a selective
inhibitor of c-MET receptor tyrosine kinase, along with other
potential new medicines. Enhertu (trastuzumab deruxtecan), a
HER2-directed antibody drug conjugate, is in development for
metastatic non-squamous HER2-overexpressing or HER2-mutated NSCLC
including trials in combination with other anticancer
treatments.
An extensive Immuno-Oncology development programme focuses on lung
cancer patients without a targetable genetic mutation which
represents up to three-quarters of all patients with lung
cancer.11 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 Immuno-Oncology
Immuno-oncology (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. In
addition to AstraZeneca's main capabilities, the Company is
actively pursuing innovative partnerships and investment that
accelerate the delivery of our strategy, as illustrated by the
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.
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 May 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. Paz-Ares L, et al. PD-L1 Expression, Patterns of Progression and
Patient-reported Outcomes (PROs) with Durvalumab Plus
Platinum-etoposide in ES-SCLC: Results from CASPIAN. Presented at
the European Society for Medical Oncology Congress. Barcelona,
Spain. 28 September 2019.
5. World Health Organization. International Agency for Research on
Cancer. Available at http://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf.
Accessed May 2020.
6. LUNGevity Foundation. Types of Lung Cancer. Available
at https://lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer.
Accessed May 2020.
7. Cancer.Net. Lung Cancer - Small Cell. Available
at https://www.cancer.net/cancer-types/33776/view-all.
Accessed May 2020.
8. Szumera-Ciećkiewicz A, et al. EGFR Mutation Testing on Cytological and
Histological Samples in Non-Small Cell Lung Cancer: a Polish,
Single Institution Study and Systematic Review of European
Incidence. Int J Clin Exp
Pathol.
2013:6;2800-12.
9. Keedy VL, et al. American Society of Clinical Oncology
Provisional Clinical Opinion: Epidermal Growth Factor Receptor
(EGFR) Mutation Testing for Patients with Advanced Non-Small-Cell
Lung Cancer Considering First-Line EGFR Tyrosine Kinase Inhibitor
Therapy. J Clin
Oncol.
2011:29;2121-27.
10. Ellison G, et al. EGFR Mutation Testing in Lung Cancer: a Review
of Available Methods and Their Use for Analysis of Tumour Tissue
and Cytology Samples. J Clin
Pathol.
2013:66;79-89.
11. 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:
27 July 2020
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By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
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