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 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
Tagrisso approved
in China as a 1st-line treatment
for EGFR-mutated non-small cell lung cancer
4 September 2019 07:00 BST
Tagrisso approved in China as a 1st-line
treatment
for EGFR-mutated non-small cell lung cancer
In the Phase III FLAURA trial, Tagrisso significantly increased
the
time patients lived without disease progression versus the
comparator
Tagrisso is the only medicine demonstrating
statistically-significant
overall survival benefit in this setting
AstraZeneca today announced that it has received marketing
authorisation from China's National Medical Products Administration
(NMPA) for Tagrisso (osimertinib) as a 1st-line treatment for
adults with locally-advanced or metastatic non-small cell lung
cancer (NSCLC) whose tumours have the genetic mutations of
epidermal growth factor receptor (EGFR) exon 19 deletions or exon
21 (L858R) substitutions.
The approval followed the Priority Review Pathway and is based on
results from the Phase III FLAURA trial, which were published
in The
New England Journal of Medicine.
Dave Fredrickson, Executive Vice President, Oncology, said: "The
FLAURA trial has demonstrated the potential
of Tagrisso as a new standard of care and as an
important new 1st-line treatment option for non-small cell lung
cancer patients in China, where approximately 30-40% are diagnosed
with an EGFR mutation - more than any other country in the
world."
In the FLAURA trial, 1st-line use of Tagrisso provided a statistically-significant and
clinically- meaningful improvement in progression-free survival
(PFS), increasing the time patients lived without disease
progression or death by a median of 18.9 months versus 10.2 months
for those taking standard EGFR tyrosine kinase inhibitor (TKI)
medicines (HR 0.46 [95% CI, 0.37-0.57], p<0.0001). This benefit
was consistent across all patient subgroups including those with
central nervous system (CNS) metastases.
Phase III FLAURA trial efficacy results according to investigator
assessment
|
Tagrisso
(N=279)
|
EGFR TKI
(gefitinib or erlotinib)
(N=277)
|
Progression-free survival
|
Median PFS
(95% confidence interval [CI])
|
18.9 months
(15.2, 21.4)
|
10.2 months
(9.6, 11.1)
|
Hazard ratio (95% CI)
|
0.46 (0.37-0.57)
|
P-value
|
P<0.0001
|
Response rate*
|
Overall response rate*
(95% CI)
|
77%
(71, 82)
|
69%
(63, 74)
|
Complete response
|
2%
|
1%
|
Partial response
|
75%
|
68%
|
Duration of response (DoR)*
|
Median DoR
(95% CI)
|
17.6 months
(13.8, 22.0)
|
9.6 months
(8.3, 11.1)
|
*Confirmed responses.
AstraZeneca recently announced that Tagrisso additionally
showed a statistically-significant and clinically-meaningful
improvement in overall survival in this patient
population.
Safety data for Tagrisso in the FLAURA trial were in line with those
observed in prior clinical trials. Tagrisso was generally well tolerated, with Grade 3
or higher adverse events (AEs) occurring in 34% of patients
taking Tagrisso versus 45% in the comparator arm. The most
common AEs in patients treated with Tagrisso were diarrhoea (58%), rash (58%), dry skin
(36%), nail toxicity (35%), stomatitis (29%), fatigue (21%) and
decreased appetite (20%).
Tagrisso was approved in
China in March 2017 and added to the National Reimbursement Drug
List (NRDL) effective from January 2019 for the 2nd-line treatment
of adult patients with locally-advanced or metastatic EGFR T790M
mutation-positive NSCLC, whose disease has progressed on or after
EGFR-TKI therapy.
About lung cancer
Lung cancer is the leading cause of cancer death among both men and
women, accounting for about one-fifth of all cancer deaths, more
than breast, prostate and colorectal cancers
combined.1Lung
cancer is broadly split into NSCLC and small cell lung cancer
(SCLC), with 80-85% classified as NSCLC.2 Approximately
10-15% of NSCLC patients in the US and Europe, and 30-40% of
patients in Asia have EGFR-mutated (EGFRm)
NSCLC.3-5 These
patients are particularly sensitive to treatment with EGFR-TKIs
which block the cell-signalling pathways that drive the growth of
tumour cells. Approximately 25% of patients with EGFRm NSCLC have
brain metastases at diagnosis, increasing to approximately 40%
within two years of diagnosis.6 The
presence of brain metastases often reduces median survival to less
than eight months in patients not treated
with Tagrisso.7
About Tagrisso
Tagrisso (osimertinib) is
a third-generation, irreversible EGFR-TKI designed to inhibit both
EGFR-sensitising and EGFR T790M-resistance mutations, with clinical
activity against CNS metastases.
Tagrisso 40mg and 80mg
once-daily oral tablets have now received approval in 75 countries,
including the US, Japan, China and the EU, for 1st-line EGFRm
advanced NSCLC, and in 84 countries, including the US, Japan, China
and the EU, for 2nd-line use in patients with EGFR T790M
mutation-positive advanced NSCLC. Tagrisso is also being developed in the adjuvant
setting (ADAURA trial), in the locally-advanced unresectable
setting (LAURA), in combination with chemotherapy in the advanced
setting (FLAURA2), and with potential new medicines, including
savolitinib in the Phase II trials SAVANNAH and
ORCHARD.
About FLAURA
The FLAURA trial assessed the efficacy and safety
of Tagrisso 80mg orally once daily vs. comparator
EGFR-TKIs (either erlotinib [150mg orally, once daily] or gefitinib
[250mg orally, once daily]) in previously-untreated patients with
locally-advanced or metastatic EGFRm NSCLC. The trial was
double-blinded and randomised, with 556 patients across 29
countries.
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 EGFRm 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, and ongoing Phase III trials ADAURA, LAURA,
FLAURA and FLAURA2 as well as the Phase II combination trials
SAVANNAH and ORCHARD.3-5
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.8,9 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) and both
as monotherapy and in combination with tremelimumab and/or
chemotherapy.
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 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.
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
|
Rebecca
Einhorn
|
Oncology
|
+1 301
518 4122
|
Matt
Kent
|
BioPharmaceuticals
|
+44 203
749 5906
|
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
(CV, metabolism)
|
+44 203
749 5711
|
Nick
Stone
|
BioPharmaceuticals
(respiratory, renal)
|
+44 203
749 5716
|
Josie
Afolabi
|
Other
medicines
|
+44 203
749 5631
|
Craig
Marks
|
Finance,
fixed income
|
+44
7881 615 764
|
Jennifer
Kretzmann
|
Corporate
access, retail investors
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+44 203
749 5824
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US
toll-free
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+1 866
381 72 77
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References
1. World Health
Organization. International Agency for Research on Cancer. Globocan
Worldwide Fact Sheet 2018. Available at http://globocan.iarc.fr/Pages/fact_sheets_population.aspx.
Accessed August 2019.
2. LUNGevity Foundation. Types of Lung
Cancer. Available at https://www.lungevity.org/about-lung-cancer/lung-cancer-101/types-of-lung-cancer.
Accessed August 2019.
3. 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 August 2019.
4. 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 August 2019.
5. 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 August 2019.
6. Rangachari, et al. Brain Metastases
in Patients with EGFR-Mutated or ALK-Rearranged Non-Small-Cell Lung
Cancers. Lung Cancer. 2015;88,108-111. Accessed August
2019.
7. Ali A, et al. Survival of Patients
with Non-small-cell Lung Cancer After a Diagnosis of Brain
Metastases. Curr Oncol. 2013;20(4):e300-e306. Accessed August
2019.
8. Barlesi F, et al. Routine molecular
profiling of patients with advanced non-small cell lung cancer:
results of a 1-year nationwide programme of the French Cooperative
Thoracic Intergroup (IFCT). The Lancet. 2016; 387: 1415-26.
9. Santarpia M, et al. Targeted drugs
in small-cell lung cancer. Transl Lung Cancer
Res. 2016;5(1):51-70.
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:
04 September
2019
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
|