TAGRISSO met the primary endpoint,
demonstrating a statistically-significant and clinically-meaningful
progression-free survival benefit in 1st-line EGFRm+ non-small cell
lung cancer compared to current standard-of-care treatment
AstraZeneca today announced that the Phase III FLAURA trial
showed a statistically-significant and clinically-meaningful
progression-free survival (PFS) benefit with TAGRISSO®
(osimertinib) compared to current 1st-line standard-of-care
treatment (erlotinib or gefitinib) in previously-untreated patients
with locally advanced or metastatic epidermal growth factor
receptor mutation-positive (EGFRm) non-small cell lung cancer
(NSCLC).
Sean Bohen, Executive Vice President, Global Medicines
Development and Chief Medical Officer at AstraZeneca, said: “The
strong results from the FLAURA trial are very exciting news for
patients with EGFR mutation-positive non-small cell lung cancer,
providing physicians with a potential new first-line treatment
option to improve outcomes in this disease. We will now initiate
discussions with global health authorities on the data and
regulatory submissions.”
The efficacy, safety and tolerability profiles for TAGRISSO,
erlotinib and gefitinib were consistent with current knowledge. A
full evaluation of the FLAURA data is ongoing. Further results will
be presented at a forthcoming medical meeting.
TAGRISSO once-daily tablets are approved for the treatment of
patients with metastatic EGFR T790M mutation-positive NSCLC, as
detected by an FDA-approved test, whose disease has progressed on
or after an EGFR tyrosine kinase inhibitor (TKI) therapy. TAGRISSO
is the first and only approved medicine in the US indicated for
NSCLC patients who have tested positive for the EGFR T790M
mutation.
TAGRISSO® (osimertinib) Important Safety
Information
- There are no contraindications for
TAGRISSO
- Interstitial Lung Disease
(ILD)/Pneumonitis occurred in 3.5% and was fatal in 0.6% of 833
TAGRISSO-treated patients. Withhold TAGRISSO and promptly
investigate for ILD in patients who present with worsening of
respiratory symptoms indicative of ILD (eg, dyspnea, cough,
and fever). Permanently discontinue TAGRISSO if ILD is
confirmed
- Heart rate-corrected QT (QTc) interval
prolongation occurred in TAGRISSO-treated patients. Of the 833
TAGRISSO-treated patients, 0.7% of patients were found to have a
QTc > 500 msec, and 2.9% of patients had an increase from
baseline QTc > 60 msec. No QTc-related arrhythmias were
reported. 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 1.9% and was
fatal in 0.1% of 833 TAGRISSO-treated patients. Left Ventricular
Ejection Fraction (LVEF) decline ≥ 10% and a drop to < 50%
occurred in 4% of 655 TAGRISSO-treated patients. Conduct cardiac
monitoring, including an assessment of LVEF at baseline and during
treatment in patients with cardiac risk factors. Assess LVEF in
patients who develop relevant cardiac signs or symptoms during
treatment. For symptomatic congestive heart failure or persistent,
asymptomatic LV dysfunction that does not resolve within 4 weeks,
permanently discontinue TAGRISSO
- Keratitis was reported in 0.7% of 833
TAGRISSO-treated patients in clinical trials. Promptly refer
patients with signs and symptoms suggestive of keratitis (such as
eye inflammation, lacrimation, light sensitivity, blurred vision,
eye pain, and/or red eye) to an ophthalmologist
- 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%) in patients treated with TAGRISSO were diarrhea (41%), rash
(34%), dry skin (23%), nail toxicity (22%), and fatigue (22%)
Please see complete Prescribing
Information including Patient Information.
– ENDS –
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-quarter of all cancer deaths,
more than breast, prostate and colorectal cancers combined.
Approximately 10% to 15% of patients in the US and Europe, and 30%
to 40% of patients in Asia have epidermal growth factor receptor
mutation-positive (EGFRm) NSCLC. These patients are particularly
sensitive to treatment with currently-available EGFR tyrosine
kinase inhibitors (TKIs), which block the cell signaling pathways
that drive the growth of tumor cells. However, tumors almost always
develop resistance to EGFR-TKI treatment, leading to disease
progression. Approximately half of patients develop resistance to
approved EGFR-TKIs, such as gefitinib and erlotinib, due to the
secondary mutation EGFR-T790M. TAGRISSO targets this secondary
mutation that leads to disease progression. There is also a need
for agents with improved central nervous system efficacy since
approximately 25% of patients with EGFRm NSCLC have brain
metastases at first diagnosis, increasing to approximately 40%
within two years of diagnosis.
About TAGRISSO® (osimertinib)
TAGRISSO® (osimertinib) is a third generation, irreversible EGFR
tyrosine kinase inhibitor (TKI) designed to inhibit both EGFR
sensitizing and EGFR T790M resistance mutations, with clinical
activity against central nervous system (CNS) metastases. TAGRISSO
40mg and 80mg once-daily oral tablets have been approved in more
than 50 countries, including the US, EU, Japan and China, for
patients with epidermal growth factor receptor (EGFR) T790M
mutation-positive advanced non-small cell lung cancer (NSCLC).
Eligibility for treatment with TAGRISSO is dependent on
confirmation that the EGFR T790M mutation is present in the
tumor.
TAGRISSO is also being investigated in the adjuvant and
metastatic first-line settings, including in patients with and
without CNS metastases, in leptomeningeal metastases, and in
combination with other treatments.
About FLAURA
FLAURA assessed the efficacy and safety of TAGRISSO®
(osimertinib) 80mg once-daily treatment versus standard-of-care
epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors
(TKIs) (either erlotinib [150mg orally, once daily] or gefitinib
[250mg orally, once daily]) in previously untreated patients with
locally advanced or metastatic EGFR mutation-positive non-small
cell lung cancer (NSCLC). The trial was a double-blinded,
randomized study, with 556 patients across 30 countries.
The primary endpoint of the trial was progression-free survival
(PFS), and secondary endpoints included overall survival, objective
response rate, duration of response, disease control rate, safety
and measures of health-related quality of life (HRQoL).
About AstraZeneca in Lung Cancer
AstraZeneca is using ground-breaking science to develop a wide
range of medicines for patients with lung cancer. We are pioneering
precision medicines that target molecular mutations in tumor cells,
as well as those that aim to boost the power of the immune response
against cancer. We are committed to transforming outcomes for
patients with lung cancer, whose treatment options are currently
limited.
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 advancing New Oncology as one of AstraZeneca’s
five 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, Tumor Drivers 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, 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-us.com and follow us on Twitter
@AstraZenecaUS.
US-11268 Last Updated
7/17
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885 2677orAlex Engel, +1 302 885 2677
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