Market Overview

TAGRISSO® (osimertinib) Significantly Improves Progression-Free Survival in the Phase III FLAURA Trial for Lung Cancer


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

  • 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
  • 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
 including Patient Information.

– ENDS –


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

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


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
and follow us on Twitter @AstraZenecaUS.

US-11268 Last Updated 7/17

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