Blueprint
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 December
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 approved in China
for the treatment of unresectable, Stage III
non-small cell lung cancer based on the Phase III PACIFIC
trial
12 December 2019 07:00 GMT
Imfinzi approved in China for the treatment of
unresectable, Stage III
non-small cell lung cancer based on the Phase III PACIFIC
trial
Imfinzi is the only immunotherapy approved in China to treat
patients
in the curative-intent Stage III setting following chemoradiation
treatment
AstraZeneca today announced that it has received marketing
authorisation from China's National Medical Products Administration
(NMPA) for Imfinzi (durvalumab) 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).
The
approval of Imfinzi is based on results from
the primary
analysis of progression-free survival (PFS) and
supported by overall survival
(OS) from the
Phase III PACIFIC trial, both published in The New England Journal of
Medicine. A post-hoc analysis of three-year
OS results has since shown that consistent efficacy was
maintained for treatment with Imfinzi after additional follow
up.1
Dave
Fredrickson, Executive Vice President, Oncology Business Unit
said: "This approval
illustrates our long-standing commitment to improving health
outcomes in China, where more than one-third of the world's lung
cancer diagnoses and deaths occur. As the global standard
of care in this curative-intent setting, Imfinzi is an important new option
for patients in China."
Results
demonstrated a statistically significant and clinically meaningful
OS and PFS benefit for treatment with Imfinzi vs. placebo after
concurrent CRT. Imfinzi reduced the risk of death
by 32% (equal to a hazard ratio of 0.68) and prolonged the time
patients lived without disease progression or death by more than 11
months (median PFS: 16.8 vs. 5.6 months; hazard ratio of
0.52).
Phase III PACIFIC trial primary endpoints
|
Imfinzi
(n=476)
|
Placebo
(n=237)
|
OS (primary endpoint)i
|
|
Number
of deaths (%)
|
183
(38.4%)
|
116
(48.9%)
|
Hazard
ratio (95% CI)ii
|
0.68
(0.53, 0.87)
|
p-valueii,iii
|
0.0025
|
Median
in months (95% CI)
|
NR4
(34.7,
NR)iv
|
28.7
(22.9,
NR)iv
|
PFS (primary endpoint)v
|
|
Number
of events (%)
|
214
(45%)
|
157
(66%)
|
Hazard
ratio (95% CI)ii,vi
|
0.52
(0.42, 0.65)
|
p-valueii,vii
|
<0.0001
|
Median
in months (95% CI)
|
16.8
(13.0,
18.1)
|
5.6
(4.6,
7.8)
|
|
|
|
|
iOS results are based on the
interim OS analysis with a data cut-off date of 22 March
2018.
iiStratified by sex, age, and
smoking history.
iiiCriteria for statistical
significance at the interim analysis of OS was a
p-value ≤ 0.00274
(using Lan DeMets spending function approximating O'Brien Fleming
boundary).
ivNot reached
(NR).
vAssessed by blinded
independent central review (BICR) according to RECIST
v1.1.
viPFS results are based on the
interim PFS analysis with a data cut-off date of 13 February
2017.
viiCriteria for statistical
significance at the interim analysis of PFS was a
p-value ≤ 0.011035
(using Lan DeMets spending function approximating O'Brien Fleming
boundary).
Among
patients treated with Imfinzi, the most common adverse
reactions (greater than or equal to 20% of patients) were cough,
fatigue, pneumonitis or radiation pneumonitis, upper respiratory
tract infections, dyspnoea, and rash. Serious adverse reactions
occurred in 29% of patients treated with Imfinzi, and 15% of patients
discontinued treatment due to adverse reactions.
Imfinzi is approved in the curative-intent setting of
unresectable, Stage III NSCLC after CRT in 54 countries and
regions, including the US, Japan and across the EU, based on the
Phase III PACIFIC trial. The
PACIFIC regimen, CRT followed by Imfinzi, is the global standard of care for the treatment
of unresectable Stage III NSCLC.
About PACIFIC
The
PACIFIC trial was a Phase III, randomised, double-blinded,
placebo-controlled, multi-centre trial of Imfinzi as treatment in
'all-comer' patients (i.e. regardless of PD-L1 status) with
unresectable, Stage III (locally advanced) NSCLC whose disease had
not progressed following concurrent platinum-based
CRT.
The
trial was conducted at 235 centres across 26 countries involving
713 patients. The primary endpoints of the trial were PFS and OS,
and secondary endpoints included landmark PFS and OS, objective
response rate, and duration of response.
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.2 Stage
III disease is different from Stage IV disease, when the cancer has
spread throughout the body (metastasised), as the majority of Stage
III patients are currently treated with curative
intent.2,3
Stage III NSCLC represents approximately one-third of NSCLC
incidence and in 2015 was estimated to affect nearly 200,000
patients in the following eight key countries: China, France,
Germany, Italy, Japan, Spain, UK, US.4,5 The
majority of Stage III NSCLC patients are diagnosed with
unresectable tumours.6 Prior
to approval of Imfinzi in this setting, no new treatments
beyond CRT had been available to patients for decades.7-10
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 11
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, biliary tract cancer, cervical 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, and FLAURA2 as well as the Phase II combination
trials SAVANNAH and ORCHARD.11-13
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.14 Imfinzi,
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, ADJUVANT
BR.31, PACIFIC-2, PACIFIC-4, PACIFIC-5, and ADRIATIC) both as
monotherapy and in combination with tremelimumab and/or
chemotherapy.
About 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, 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 AstraZeneca's
Oncology pipeline, and from 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 (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.
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
|
Jennifer
Hursit
|
Other
|
+44
203 749 5762
|
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Hägerstrand
|
Sweden
|
+46 8 552 53 106
|
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Meixell
|
US
|
+1 302
885 2677
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Investor
Relations
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Thomas
Kudsk Larsen
|
|
+44 203
749 5712
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Henry
Wheeler
|
Oncology
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+44 203
749 5797
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Gruvris
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|
+44 203
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Stone
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+44 203
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References
1. Gray JE, et al. Brief Report: Three-year Overall Survival with
Durvalumab after Chemoradiotherapy in Stage III NSCLC - Update from
PACIFIC. Journal of Thoracic
Oncology. 2019
doi:10.1016/j.jtho.2019.10.002. Accessed December
2019.
2. ASCO. Cancer.net. Lung Cancer - Non-Small Cell. Available
at: https://www.cancer.net/cancer-types/lung-cancer/view-all.
Accessed December 2019.
3. Cheema PK, et al. Perspectives on Treatment Advances For Stage III
Locally Advanced Unresectable Non-Small-Cell Lung
Cancer. Curr Oncol. 2019;26(1):37-42. doi:10.3747/co.25.4096.
Accessed December 2019.
4. Antonia SJ, et al. PACIFIC Investigators. Durvalumab After
Chemoradiotherapy In Stage III Non-Small-Cell Lung
Cancer. N Engl J
Med.
2017;377(20):1919-1929.
5. EpiCast Report: NSCLC Epidemiology Forecast to 2025. GlobalData.
2016. Accessed December 2019.
6. Provencio M, et al. Inoperable Stage III Non-Small Cell Lung Cancer:
Current Treatment And Role Of Vinorelbine. J Thorac
Dis. 2011;3:197-204. Accessed
December 2019.
7. Eberhardt WE, et al. Panel Members. 2nd ESMO Consensus Conference in
Lung Cancer: locally advanced Stage III non-small-cell lung
cancer. Ann Oncol. 2015;26(8):1573-1588. Accessed December
2019.
8. Gandara DR, et al. Long-Term Survival with Concurrent CRT Followed
by Consolidation Docetaxel in Stage IIIB Non-Small-Cell Lung
Cancer: A Phase II Southwest Oncology Group Study (S9504). Clin
Lung Cancer. 2006;8(2):116-121. Accessed December
2019.
9. Hanna N. Current Standards and Clinical Trials in Systemic
Therapy for Stage III Lung Cancer: What is New? Am Soc Clin Oncol
Educ Book. 2015:e442-447. Accessed December 2019.
10. NCCN Clinical Practice Guidelines in Oncology (NCCN
Guidelines). Non-small cell lung cancer, version 8.
2017. https://www.nccn.org/professionals/physician_gls/pdf/nscl_blocks.pdf.
Published August 3, 2017. Accessed December
2019.
11. 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.
12. 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.
13. 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.
14. 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:
12 December
2019
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
|