TIDMAZN
RNS Number : 1622L
AstraZeneca PLC
04 September 2019
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 EGFR TKI
(N=279) (gefitinib or erlotinib)
(N=277)
Progression-free survival
Median PFS 18.9 months 10.2 months
(95% confidence interval [CI]) (15.2, 21.4) (9.6, 11.1)
------------- -------------------------
Hazard ratio (95% CI) 0.46 (0.37-0.57)
----------------------------------------
P-value P<0.0001
----------------------------------------
Response rate*
Overall response rate* 77% 69%
(95% CI) (71, 82) (63, 74)
------------- -------------------------
Complete response 2% 1%
------------- -------------------------
Partial response 75% 68%
------------- -------------------------
Duration of response (DoR)*
Median DoR 17.6 months 9.6 months
(95% CI) (13.8, 22.0) (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.(1) Lung
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
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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
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