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
2019
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 is first immunotherapy to
show both significant survival benefit and improved, durable
responses in extensive-stage small cell lung
cancer
9 Sept 2019 08:38 BST
Imfinzi is first immunotherapy to show both
significant survival benefit
and improved, durable responses in extensive-stage small cell lung
cancer
In the Phase III CASPIAN trial Imfinzi at a fixed, convenient dose
improved
survival with either a cisplatin or carboplatin chemotherapy
backbone
AstraZeneca today presented detailed results from the Phase III
CASPIAN trial, showing Imfinzi (durvalumab) significantly improved
overall survival (OS) in patients with previously-untreated
extensive-stage small cell lung cancer (SCLC).
Imfinzi in combination
with four cycles of standard-of-care (SoC) chemotherapy (etoposide
with either cisplatin or carboplatin) demonstrated a
statistically-significant and clinically-meaningful improvement in
OS vs. SoC consisting of up to six cycles of chemotherapy and
optional prophylactic cranial irradiation
(PCI).
The risk of death was reduced by 27% (equal to a hazard ratio of
0.73), with median OS of 13.0 months for Imfinzi plus chemotherapy vs. 10.3 months for SoC.
Results showed a prolonged OS benefit with an estimated 33.9% of
patients alive at 18 months following treatment
with Imfinzi plus chemotherapy vs. 24.7% of patients
following SoC.
Across all efficacy endpoints, benefits were observed in patients
treated with Imfinzi plus chemotherapy vs. SoC. Results showed a
significantly higher progression-free survival (PFS) rate at 12
months (17.5% vs. 4.7%), a 10.3% increase in confirmed objective
response rate (ORR) (67.9% vs. 57.6%), and improved duration of
response (DOR) at 12 months (22.7% vs. 6.3%).
The results were presented at the Presidential Symposium of the
IASLC 2019 World Conference on Lung Cancer hosted by the
International Association for the Study of Lung Cancer in
Barcelona, Spain.
José Baselga, Executive Vice President, Oncology R&D
said: "We are encouraged to see more than a third of small cell
lung cancer patients treated with Imfinzi plus chemotherapy alive at the 18-month
landmark, which is remarkable given the aggressive nature of the
disease. It is also noteworthy that these results may enable
physicians to choose Imfinzi in combination with either cisplatin or
carboplatin chemotherapy backbones. We look forward to working with
regulatory authorities to bring Imfinzi to patients with small cell lung cancer
around the world as soon as possible."
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: "Patients have
had limited treatment options for small cell lung cancer, a
devastating disease where the five-year survival rate has been as
low as 6%. The significant survival benefit demonstrated
with Imfinzi combined with only four cycles of a choice
of chemotherapy compared to a robust control arm, provides evidence
and hope of a new treatment option for these
patients."
SCLC is an aggressive, fast-growing cancer that recurs and
progresses rapidly despite initial response to platinum-based
chemotherapy.1
Summary of results
|
EP + Imfinzii
(n=268)
|
EPi
(n=269)
|
OS (primary
endpoint)ii
|
|
Number of deaths (%)
|
155 (57.8%)
|
181 (67.3%)
|
Hazard ratio
(95% CI)
|
0.73 (0.591, 0.909)
|
p-value
|
0.0047
|
Median in months
(95% CI)
|
13.0
(11.5, 14.8)
|
10.3
(9.3, 11.2)
|
OS rate (18 months)
|
33.9%
|
24.7%
|
PFS (secondary
endpoint)ii,iii
|
|
Number (%) of patients with event
|
226 (84.3%)
|
233 (86.6%)
|
Hazard ratio
(95% CI)
|
0.78 (0.645, 0.936)
|
Median in months
(95% CI)
|
5.1
(4.7, 6.2)
|
5.4
(4.8, 6.2)
|
PFS rate (12 months)
|
17.5%
|
4.7%
|
ORR (secondary
endpoint)ii,iv
|
|
Number (%) of patients with response
|
182 (67.9%)
|
155 (57.6%)
|
Odds ratio
(95% CI)
|
1.56 (1.095, 2.218)
|
DOR at 12 months (secondary endpoint)
|
22.7%
|
6.3%
|
i Etoposide plus
investigator choice of cisplatin or carboplatin
chemotherapy.
iiThe data cut-off date for
analysis of OS, PFS and ORR was 11 March 2019.
iiiPFS was not formally tested
for statistical significance.
ivConfirmed responses according
to investigator assessment per RECIST v1.1.
The safety and tolerability of Imfinzi in combination with SoC etoposide and
platinum-based chemotherapy was consistent with previous trials.
Results showed that 61.5% of patients experienced a Grade 3 or 4 AE
with Imfinzi plus
SoC (all causes) vs. 62.4% with SoC, and patients
discontinuing treatment due to AEs were similar between arms
(9.4% vs. 9.4%).
Imfinzi is also being
tested following concurrent chemoradiation therapy in limited-stage
SCLC in the Phase III ADRIATIC trial.
Imfinzi is approved in the
curative-intent setting of unresectable, Stage III non-small cell
lung cancer after chemoradiotherapy in 49 countries, including the
US, Japan and across the EU, based on the Phase III PACIFIC
trial.
About CASPIAN
The CASPIAN trial is a randomised, open-label, multi-centre,
global, Phase III trial in the 1st-line treatment of patients with
extensive-stage SCLC. The trial compared Imfinzi in combination with etoposide and either
cisplatin or carboplatin chemotherapy, or Imfinzi, tremelimumab and chemotherapy vs.
chemotherapy alone. In the experimental arms, patients were treated
with up to four cycles of chemotherapy. In comparison, the control
arm allowed up to six cycles of chemotherapy and optional PCI. The
trial will continue to the final analysis of OS for the combination
of Imfinzi, tremelimumab and
chemotherapy.
The trial is being conducted in more than 200 centres across 22
countries, including in the US, Europe, South America, Asia and the
Middle East. The primary endpoint is OS.
About 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.2 Lung
cancer is broadly split into NSCLC and SCLC, with about 15%
classified as SCLC.3 About
three quarters 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. Prognosis is particularly poor, as only
6% of all SCLC patients will be alive five years after
diagnosis.4
About 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 also approved
for previously-treated patients with advanced bladder cancer in 10
countries, including the US.
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,
small cell lung cancer, bladder cancer, head and neck cancer, liver
cancer, cervical cancer, biliary tract cancer and other solid
tumours.
About AstraZeneca in lung cancer
AstraZeneca has a comprehensive portfolio of approved and potential
new medicines in late-stage clinical development for the treatment
of different forms of lung cancer spanning 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 our approved
medicines Iressa (gefitinib) and Tagrisso (osimertinib), and ongoing Phase III trials
ADAURA, LAURA, FLAURA and FLAURA2 as well as the Phase II
combination trials SAVANNAH and ORCHARD.5-7
Our extensive late-stage Immuno-Oncology programme focuses on lung
cancer patients without a targetable genetic mutation which
represents approximately three-quarters of all patients with lung
cancer.8 Imfinzi (durvalumab),
an anti-PDL1 antibody, is in development for patients with advanced
disease (Phase III trials POSEIDON, PEARL, and CASPIAN) and for
patients in earlier stages of disease including
potentially-curative settings (Phase III trials AEGEAN, PACIFIC-2,
ADRIATIC, ADJUVANT BR.31, PACIFIC-4, and PACIFIC-5) both as
monotherapy and in combination with tremelimumab and/or
chemotherapy.
About AstraZeneca's approach to Immuno-Oncology (IO)
IO is a therapeutic approach designed to stimulate the body's
immune system to attack tumours. Our IO portfolio is anchored by
immunotherapies that have been designed to overcome anti-tumour
immune suppression. We believe that IO-based therapies offer the
potential for life-changing cancer treatments for the clear
majority of patients.
We are pursuing a comprehensive clinical-trial programme that
includes Imfinzi (anti-PDL1) as monotherapy and in
combination with tremelimumab (anti-CTLA4) 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 radiation, chemotherapy, small targeted
molecules from across our Oncology pipeline, and from 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, 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.
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, CVRM and Respiratory. AstraZeneca
operates in over 100 countries and its innovative medicines are
used by millions of patients worldwide. For more information,
please visit astrazeneca.com and
follow us on Twitter @AstraZeneca.
Media Relations
|
|
|
Gonzalo
Viña
|
|
+44 203 749 5916
|
Rob
Skelding
|
Oncology
|
+44 203 749 5821
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Rebecca
Einhorn
|
Oncology
|
+1 301 518 4122
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Matt
Kent
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BioPharmaceuticals
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+44 203 749 5906
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Jennifer
Hursit
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Other
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+44 203 749 5762
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Malmberg Hägerstrand
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Sweden
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Meixell
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US
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+1 302 885 2677
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Investor Relations
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Thomas
Kudsk Larsen
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+44 203 749 5712
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Henry
Wheeler
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+44 203 749 5797
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Christer
Gruvris
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BioPharmaceuticals (CV, metabolism)
|
+44 203 749 5711
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Stone
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BioPharmaceuticals (respiratory, renal)
|
+44 203 749 5716
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Josie
Afolabi
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Other medicines
|
+44 203 749 5631
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Marks
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Finance, fixed income
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Kretzmann
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Corporate access, retail investors
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toll-free
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References
1. 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.
2. World Health Organization. International Agency for Research on
Cancer. Available at http://globocan.iarc.fr/Pages/fact_sheets_population.aspx.
Accessed May 2019.
3. LUNGevity Foundation. Types of Lung Cancer. Available
at https://lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer.
Accessed May 2019.
4. Cancer.Net. Lung Cancer - Small Cell. Available
at https://www.cancer.net/cancer-types/33776/view-all.
Accessed May 2019.
5. 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.
Accessed July 2019.
6. 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.
Accessed July 2019.
7. 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. Accessed
July 2019.
8. 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:
09
September
2019
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
|