TIDMAZN
RNS Number : 0793R
AstraZeneca PLC
06 December 2016
06 December 2016 09:30
TAGRISSO DEMONSTRATES SUPERIORITY OVER CHEMOTHERAPY IN EGFR
T790M MUTATION-POSITIVE NON-SMALL CELL LUNG CANCER
First randomised Phase III trial (AURA3) of Tagrisso against
chemotherapy
Tagrisso reduced risk of disease progression by 70% and improved
progression-free survival (PFS) by almost six months
Patients with central nervous system metastases achieved similar
benefit as the overall patient population in pre-specified
exploratory subgroup analysis
AstraZeneca today presented data from the AURA3 trial that is
supportive of Tagrisso (osimertinib) potentially becoming the new
standard of care for 2nd-line treatment of patients with epidermal
growth factor receptor (EGFR) T790M mutation-positive
locally-advanced or metastatic non-small cell lung cancer (NSCLC).
The first randomised Phase III data showed that Tagrisso 2nd-line
therapy improved progression-free survival (PFS) by 5.7 months
compared with standard platinum-based doublet chemotherapy (Hazard
Ratio [HR]=0.3). The results were presented at the 17th World
Conference on Lung Cancer (WCLC) in Vienna, Austria, hosted by the
International Association for the Study of Lung Cancer, and
published simultaneously online in The New England Journal of
Medicine.
http://www.rns-pdf.londonstockexchange.com/rns/0793R_-2016-12-6.pdf
Sean Bohen, Executive Vice President, Global Medicines
Development and Chief Medical Officer at AstraZeneca, said: "The
confirmatory Phase III data suggest the potential for Tagrisso to
replace chemotherapy as the standard of care for patients who have
progressed following EGFR tyrosine kinase inhibitor treatment. As
lung cancer is the most common type of cancer to spread to the
brain, it is also encouraging to see the activity of Tagrisso in
patients with central nervous system metastases whose prognosis is
often particularly poor."
AURA3 data showed Tagrisso offered a statistically-significant
improvement in PFS versus standard platinum-based doublet
chemotherapy (10.1 months vs 4.4 months, hazard ratio [HR] 0.30;
95% confidence interval (CI):0.23, 0.41; p<0.001). In the 34% of
patients with central nervous system (CNS) metastases at baseline,
PFS was also significantly greater with Tagrisso than with
platinum-based doublet chemotherapy (8.5 months vs 4.2 months, HR
0.32; 95% CI: 0.21, 0.49).
Dr. Vassiliki A Papadimitrakopoulou, from the University of
Texas MD Anderson Cancer Center, Houston, Texas, USA, said: "The
results of AURA3 are not only statistically significant, but
clinically meaningful because it is the first time a targeted
medicine like Tagrisso has shown improvement in progression-free
survival over standard platinum-pemetrexed chemotherapy. It's very
rewarding to be able to give this type of news to patients, as it
highlights the major advances we are making in targeted lung cancer
treatments."
Professor Tony Mok, from the Chinese University of Hong Kong,
Hong Kong said: "The superiority of Tagrisso in progression free
survival and response rate over platinum-pemetrexed chemotherapy
suggests we may be moving towards a new standard of care for
patients with resistance to EGFR TKI. With the publication of the
AURA3 data, clinicians should perform T790M mutation testing to
ensure Tagrisso be given to patients who are most likely to
benefit."
The AURA3 safety data for Tagrisso were in line with previous
experience. Grade >=3 drug-related adverse events (AEs) were
reported in 6% of patients (n=16) treated with Tagrisso and 34%
(n=46) treated with platinum-based doublet chemotherapy. The most
common drug-related AEs in the Tagrisso group, were diarrhoea (29%
overall; 1% Grade >=3) and rash (28% overall; <1% Grade
>=3) and, in the chemotherapy group, they were nausea (47%
overall; 3% Grade >=3) and decreased appetite (32% overall; 3%
Grade >=3).
The data for AURA3 are consistent with those previously
presented in the Phase II trials, AURA2 and AURA extension. This
consistency extends to testing of tissue and plasma samples for the
detection of the EGFR T790M resistance mutation. In AURA3,
approximately half of patients with T790M in tumour tissue also had
the T790M mutation detected in plasma. Clinical benefits were
reported with Tagrisso compared to platinum-based doublet
chemotherapy, irrespective of whether the T790M mutation was
identified by plasma ctDNA or tissue testing. When feasible, tissue
testing is recommended for patients with a negative plasma T790M
test.
Tagrisso was granted accelerated approval by the US Food and
Drug Administration (FDA) in November 2015 for the treatment of
patients with metastatic epidermal growth factor receptor (EGFR)
T790M mutation-positive non-small cell lung cancer (NSCLC), as
detected by an FDA-approved test, who have progressed on or after
EGFR tyrosine kinase inhibitor (TKI) therapy. In the EU, Tagrisso
was granted conditional marketing authorisation for adult patients
with locally advanced or metastatic EGFR T790M NSCLC, irrespective
of previous EGFR-TKI treatment by the European Medicines Agency
(EMA) in February 2016.
In addition, Tagrisso received approval in Japan in March 2016
for the treatment of patients with EGFR T790M mutation-positive
inoperable or recurrent NSCLC that is resistant to EGFR TKI
therapy, and it is currently under fast frack review in China,
where nearly half of lung cancer patients are thought to have the
EGFR mutation.
To view and download additional supporting materials including
backgrounders, infographics and images, please visit:
https://www.astrazeneca.com/oncology-events.html, where they are
available throughout WCLC 2016.
About AURA3
AURA3 compared the efficacy and safety of Tagrisso 80mg once
daily and platinum-based doublet chemotherapy (platinum-pemetrexed)
in 419 patients with EGFR T790M mutation-positive, locally-advanced
or metastatic NSCLC whose disease had progressed on or after
treatment with a previous EGFR tyrosine kinase inhibitor (TKI). The
trial was carried out in more than 130 locations worldwide,
including the USA, Canada, Europe, China, Japan, Korea, Taiwan and
Australia.
The primary endpoint of the trial was PFS, and secondary
endpoints included overall survival (OS), overall response rate
(ORR), duration of response (DoR), disease control rate (DCR),
safety and measures of health-related quality of life (HRQoL).
About Non-Small Cell Lung Cancer (NSCLC)
Lung cancer is the leading cause of cancer death among both men
and women, accounting for about one-third of all cancer deaths and
more than breast, prostate and colorectal cancers combined. Among
patients with lung cancer, 25% to 40% have brain metastases at some
time in the course of their disease. Patients who have the EGFRm
form of NSCLC, which occurs in 10-15% of NSCLC patients in the US
and Europe and 30-40% of NSCLC patients in Asia, are particularly
sensitive to treatment with currently-available EGFR-TKIs, which
block the cell signalling pathways that drive the growth of tumour
cells. However, tumours almost always develop resistance to
treatment, leading to disease progression. Approximately two-thirds
of patients develop resistance to approved EGFR-TKIs such as
gefitinib and erlotinib due to the secondary mutation, T790M.
About Tagrisso
Tagrisso (osimertinib, AZD9291) 80mg once daily tablet is
approved in the US, EU, Japan, Canada, Switzerland, Israel, Mexico,
Australia and a number of other countries as the first treatment
for patients with locally-advanced or metastatic EGFR T790M
mutation-positive NSCLC. Tagrisso is also approved in South Korea
in the same indication. Eligibility for treatment with Tagrisso is
dependent on confirmation that the EGFR T790M mutation is present
in the tumour.
Tagrisso has one of the fastest development programmes, from
start of clinical trials to approval in just over two and a half
years. Tagrisso is as an irreversible EGFR inhibitor, born out of
scientific exploration and engineered to combat the mechanism of
resistance by targeting the T790M resistance mutation. Tagrisso is
also investigated in the adjuvant and metastatic first-line
settings, including in patients with and without brain metastases,
in leptomeningeal disease, and in combination with other
treatments.
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, we
are committed to advance New Oncology as one of AstraZeneca's six
Growth Platforms focused on lung, ovarian, breast and blood
cancers. In addition to our core capabilities, we actively pursue
innovative partnerships and investments that accelerate the
delivery of our strategy as illustrated by our investment in Acerta
Pharma in haematology.
By harnessing the power of four scientific platforms -
immuno-oncology, the genetic drivers of cancer 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 main therapy areas - Oncology, Cardiovascular & Metabolic
Diseases and Respiratory. The Company also is selectively active in
the areas of autoimmunity, neuroscience and infection. AstraZeneca
operates in over 100 countries and its innovative medicines are
used by millions of patients worldwide. For more information,
please visit www.astrazeneca.com and follow us on Twitter
@AstraZeneca.
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