TAGRISSO demonstrated superior progression-free
survival compared to standard platinum-based chemotherapy, with a
safety profile consistent with previous trials
First randomized trial to evaluate the clinical
benefit of an EGFR T790M medicine, and data are consistent with
those supporting TAGRISSO approvals
AstraZeneca today announced that the AURA3 Phase III trial met
its primary endpoint, demonstrating superior progression-free
survival (PFS) compared to standard platinum-based doublet
chemotherapy. The AURA3 randomized trial assessed the efficacy and
safety of TAGRISSO® (osimertinib) as a second-line treatment in
more than 400 patients with EGFR T790M mutation-positive,
locally-advanced or metastatic NSCLC, whose disease had progressed
following first-line EGFR tyrosine kinase inhibitor (TKI) therapy.
TAGRISSO also demonstrated a safety profile consistent with
previous trials.
In addition to PFS, the objective response rate (ORR), disease
control rate (DCR) and duration of response (DoR) also achieved
clinically meaningful improvement versus chemotherapy. A full
evaluation of AURA3 data, including an analysis of overall survival
(OS), is ongoing, and results will be presented at an upcoming
medical meeting.
Sean Bohen, Executive Vice President, Global Medicines
Development and Chief Medical Officer at AstraZeneca, said: “These
results confirm TAGRISSO as a meaningful alternative to benefit
EGFR T790M lung cancer patients. The AURA3 results demonstrate the
benefits of our science-led approach that enabled the rapid
development of TAGRISSO as a targeted treatment to address the most
common cause of resistance to a first-generation EGFR-TKI for
patients with metastatic EGFR-mutant lung cancer. We remain
committed to exploring the potential of TAGRISSO to further extend
its reach and help meet patient need.”
TAGRISSO is one of the fastest development programs ever, from
start of clinical trials to approval in just over two and a half
years. It was approved in the US, EU, Japan, Canada, Switzerland,
Israel and Mexico as the first treatment for patients with EGFR
T790M mutation-positive locally advanced/metastatic 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 tumor.
AstraZeneca is committed to exploring the full potential of
TAGRISSO along with the rest of our outstanding oncology
portfolio.
IMPORTANT SAFETY INFORMATION
- There are no contraindications for
TAGRISSO
- Interstitial Lung Disease
(ILD)/Pneumonitis occurred in 3.3% and was fatal in 0.5% of 813
TAGRISSO patients. Withhold TAGRISSO and promptly investigate for
ILD in any patient presenting with worsening of respiratory
symptoms indicative of ILD (e.g., dyspnea, cough and fever).
Permanently discontinue TAGRISSO if ILD is confirmed
- QTc interval prolongation occurred in
TAGRISSO patients. Of the 411 patients in two Phase II studies,
0.2% were found to have a QTc greater than 500 msec, and 2.7% had
an increase from baseline QTc greater than 60 msec. Conduct
periodic monitoring with ECGs and electrolytes in patients with
congenital long QTc syndrome, congestive heart failure, electrolyte
abnormalities, or those who are taking medications known to prolong
the QTc interval. Permanently discontinue TAGRISSO in patients who
develop QTc interval prolongation with signs/symptoms of life
threatening arrhythmia
- Cardiomyopathy occurred in 1.4% and was
fatal in 0.2% of 813 TAGRISSO patients. Left Ventricular Ejection
Fraction (LVEF) decline >10% and a drop to <50% occurred in
2.4% of (9/375) TAGRISSO patients. Assess LVEF before initiation
and then at 3 month intervals of TAGRISSO treatment. Withhold
TAGRISSO if ejection fraction decreases by 10% from pretreatment
values and is less than 50%. For symptomatic congestive heart
failure or persistent asymptomatic LV dysfunction that does not
resolve within 4 weeks, permanently discontinue TAGRISSO
- Advise pregnant women of the potential
risk to a fetus. Advise females of reproductive potential to use
effective contraception during TAGRISSO treatment and for 6 weeks
after the final dose. Advise males with female partners of
reproductive potential to use effective contraception for 4 months
after the final dose
- The most common adverse reactions
(>20%) observed in TAGRISSO patients were diarrhea (42%), rash
(41%), dry skin (31%) and nail toxicity (25%)
INDICATION
TAGRISSO is indicated 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 therapy.
This indication is approved under accelerated approval based on
tumor response rate and duration of response. Continued approval
for this indication may be contingent upon verification and
description of clinical benefit in confirmatory trials.
AURA3, an open label, randomized Phase III study designed to
assess the efficacy and safety of osimertinib (AZD9291) versus
platinum-based doublet chemotherapy in patients with EGFR T790M
positive, locally advanced, or metastatic NSCLC who have progressed
following prior therapy with an EGFR-TKI, is the key confirmatory
trial for osimertinib.
Please see complete Prescribing Information including Patient
Information.
NOTES TO EDITORS
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,
more than breast, prostate and colorectal cancers combined. Lung
cancer has a five-year survival rate that is less than 20%.
Approximately 85% of all lung cancers in the US are NSCLC; 10% to
15% of these are EGFR mutation-positive. Approximately two-thirds
of patients treated with EGFR TKI therapy will acquire resistance
related to the T790M mutation.
About TAGRISSO® (osimertinib)
TAGRISSO (osimertinib) 80mg once-daily tablet is the first
medicine indicated for the treatment of metastatic epidermal growth
factor receptor (EGFR) T790M mutation-positive NSCLC, as detected
by an FDA-approved test, who have progressed on or after EGFR
tyrosine kinase inhibitor therapy. 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.
About AURA3
AURA3 compared the efficacy and safety of TAGRISSO 80mg once
daily and platinum-based doublet chemotherapy 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-TKI. The trial was carried out in more than 130 locations
worldwide, including the US, Canada, Europe, China, Japan, Korea,
Taiwan and Australia.
The primary endpoint of the trial is PFS, and secondary
endpoints include OS, ORR, DoR, DCR, safety and measures of
health-related quality of life (HRQoL).
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 6 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 hematology.
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 personalized 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 commercialization of
prescription medicines, primarily for the treatment of diseases in
three main therapy areas – oncology; respiratory and autoimmunity;
and cardiovascular and metabolic disease. We are also active in
infection, neuroscience and inflammatory diseases through
collaborations with others. AstraZeneca operates in over 100
countries and its innovative medicines are used by millions of
patients worldwide. For more information please visit:
www.astrazeneca-us.com
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