a4187g
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 March
2020
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F X Form 40-F __
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1):
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ______
Indicate
by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information
to the Commission pursuant to Rule 12g3-2(b) under the Securities
Exchange Act of 1934.
Yes __
No X
If
“Yes” is marked, indicate below the file number
assigned to the Registrant in connection with Rule 12g3-2(b):
82-_____________
AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Imfinzi confirmed a sustained overall
survival benefit in final analysis of the Phase III
CASPIAN trial in 1st-line extensive-stage small cell lung
cancer
17 March 2020 07:00 GMT
Imfinzi confirmed
a sustained overall survival benefit
in final analysis of the Phase III CASPIAN
trial in 1st-line extensive-stage small cell lung
cancer
A second immunotherapy, tremelimumab, added
to Imfinzi, did not meet its primary endpoint of overall
survival
High-level results from the final analysis of the Phase III CASPIAN
trial showed AstraZeneca's Imfinzi (durvalumab) in combination with a choice of
standard-of-care (SoC) chemotherapies confirmed a sustained,
clinically meaningful overall survival (OS) benefit for patients
with extensive-stage small cell lung cancer (ES-SCLC) treated in
the 1st-line setting.
In June 2019, the CASPIAN trial met
one primary
endpoint for Imfinzi plus SoC (etoposide and either carboplatin
or cisplatin chemotherapy) by demonstrating a statistically
significant and clinically meaningful improvement in OS versus SoC
alone at a planned interim
analysis.
The second experimental arm testing tremelimumab, an
anti-CTLA4 monoclonal antibody, added to Imfinzi and SoC did not meet its primary endpoint of
demonstrating a statistically significant improvement in OS in this
analysis.
José Baselga, Executive Vice President,
Oncology R&D, said: "We are pleased to see the sustained and
meaningful survival benefit of Imfinzi for patients with small cell lung cancer
after more than two years median follow up. We have already
received the first global regulatory approval
for Imfinzi with etoposide plus either carboplatin or
cisplatin and remain on track for more approvals soon as we provide
patients an important new 1st-line treatment
option."
The safety and tolerability for Imfinzi and tremelimumab were consistent with the
known safety profiles of these medicines. The data will be
presented at a forthcoming medical meeting.
Imfinzi in combination
with etoposide and either carboplatin or cisplatin is currently
under regulatory review for the treatment of ES-SCLC in the
1st-line setting based on the Phase III CASPIAN trial in the US, EU
and Japan. The US Food and Drug Administration has granted
a Priority
Review with a Prescription
Drug User Fee Act date set for the first quarter of
2020.
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 with data anticipated in
2021.
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.1 Lung
cancer is broadly split into non-small cell lung cancer (NSCLC) and
SCLC, with about 15% classified as SCLC.2 SCLC
is a highly aggressive, fast-growing form of lung cancer that
typically recurs and progresses rapidly despite initial response to
chemotherapy.3,4 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.5 Prognosis
is particularly poor, as only 6% of all SCLC patients will be alive
five years after diagnosis.5
CASPIAN
CASPIAN is 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.
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 recently received its first global approval
for the 1st-line treatment of ES-SCLC in combination with SoC
chemotherapy in Singapore. 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
combination 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 and other solid
tumours.
Tremelimumab
Tremelimumab is a human monoclonal antibody and potential new
medicine that targets the activity of cytotoxic
T-lymphocyte-associated protein 4 (CTLA-4). Tremelimumab blocks the
activity of CTLA-4, contributing to T cell activation, priming the
immune response to cancer and fostering cancer cell death.
Tremelimumab is being tested in a clinical trial programme in
combination with Imfinzi in NSCLC, SCLC, bladder cancer, head and
neck cancer and liver cancer.
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. We
aim 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 ADAURA, LAURA, and FLAURA2.6-8 We
are also 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 late-stage Immuno-Oncology programme focuses on lung
cancer patients without a targetable genetic mutation which
represents up to three-quarters of all patients with lung
cancer.9 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 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
combination trials NeoCOAST, COAST and HUDSON in combination with
potential new medicines from the early-stage
pipeline.
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. The Company's
IO portfolio is anchored by immunotherapies that have been designed
to overcome anti-tumour immune suppression. AstraZeneca believes
that IO-based therapies offer the potential for life-changing
cancer treatments for the clear majority of patients.
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 six 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 investments 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 and Metabolism, and Respiratory.
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.
Media
Relations
|
|
|
Gonzalo
Viña
|
|
+44 203
749 5916
|
Rob
Skelding
|
Oncology
|
+44 203
749 5821
|
Rebecca
Einhorn
|
Oncology
|
+1 301
518 4122
|
Matt
Kent
|
BioPharmaceuticals
|
+44 203
749 5906
|
Angela
Fiorin
|
BioPharmaceuticals
|
+44
1223 344 690
|
Jennifer
Hursit
|
Other
|
+44
203 749 5762
|
Christina Malmberg
Hägerstrand
|
Sweden
|
+46 8 552 53 106
|
Michele
Meixell
|
US
|
+1 302
885 2677
|
Investor
Relations
|
|
|
Thomas
Kudsk Larsen
|
|
+44 203
749 5712
|
Henry
Wheeler
|
Oncology
|
+44 203
749 5797
|
Christer
Gruvris
|
BioPharmaceuticals
(Cardiovascular,
Metabolism)
|
+44 203
749 5711
|
Nick
Stone
|
BioPharmaceuticals
(Renal) Environmental, Social and Governance
|
+44 203
749 5716
|
Josie
Afolabi
|
BioPharmaceuticals
(Respiratory)
|
+44 203
749 5631
|
Tom
Waldron
|
Other
medicines
|
+44
7385 033 717
|
Craig
Marks
|
Finance
Fixed
income
|
+44
7881 615 764
|
Jennifer
Kretzmann
|
Corporate
access
Retail
investors
|
+44 203
749 5824
|
US
toll-free
|
|
+1 866
381 72 77
|
References
1. 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 March 2020.
2. LUNGevity
Foundation. Types of Lung Cancer. Available
at https://lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer.
Accessed March 2020.
3. 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 March 2020.
4. Kalemkerian
GP, et
al. Treatment Options for
Relapsed Small-Cell Lung Cancer: What Progress Have We
Made? Journal of Oncology
Practice, volume 14, issue no.
6 (June 1, 2018) 369-370.
5. Cancer.Net. Lung
Cancer - Small Cell. Available at https://www.cancer.net/cancer-types/33776/view-all.
Accessed March 2020.
6. 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.
7. 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.
8. 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.
9. 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:
17 March
2020
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
|