Study published in the NEJM shows that oral IRESSA(TM) (GEFITINIB) provides superior efficacy compared to doublet chemotherapy in Phase III first-line study in non small cell lung cancer (NSCLC)



    FOR IMMEDIATE RELEASE

    MISSISSAUGA, ON, Aug. 19 /CNW/ - Data from the Phase III first-line
IRESSA Pan-Asia Study (IPASS)(1), published today in The New England Journal
of Medicine, demonstrated superior progression-free survival (PFS: the length
of time a patient lives without their tumour growing) for the oral anti-cancer
drug IRESSA, compared with intravenous carboplatin/paclitaxel chemotherapy in
the overall population of clinically selected patients with advanced NSCLC in
Asia (Hazard ratio (HR) 0.74, 95 per cent confidence interval (CI) 0.65 to
0.85, p less than 0.0001). This is the first time a targeted monotherapy has
demonstrated significantly longer PFS than doublet chemotherapy.
    The EGFR (epidermal growth factor receptor) mutation status of a
patient's tumour was a strong predictor of benefit with IRESSA or
chemotherapy. Pre-planned sub-group analyses showed that PFS was significantly
longer for IRESSA than chemotherapy in patients with EGFR mutation positive
tumours (HR 0.48, 95 per cent CI 0.36 to 0.64, p less than 0.0001), and
significantly longer for chemotherapy than IRESSA in patients with EGFR
mutation negative tumours (HR 2.85, 95 per cent CI 2.05 to 3.98, p less than
0.0001).
    IRESSA also demonstrated significant benefits in response rates and
offered a more favourable tolerability profile with superior quality of life
improvement rates for patients versus chemotherapy.
    IPASS was an open label, randomized, parallel-group study that assessed
the efficacy, safety and tolerability of IRESSA versus carboplatin/paclitaxel
as first-line treatment in a clinically selected population of patients from
Asia. The primary endpoint of IPASS was PFS, with the objective of
demonstrating that IRESSA was non-inferior to (at least as good as)
carboplatin/paclitaxel doublet chemotherapy. The IPASS study exceeded its
primary objective and demonstrated superiority of IRESSA relative to
carboplatin/paclitaxel in terms of progression-free survival.
    The study enrolled 1,217 patients in Asia with advanced NSCLC who had not
received prior chemotherapy for advanced disease, whose tumours were of
adenocarcinoma histology and who had either never smoked, or were former light
smokers (ceased smoking at least 15 years ago and less than or equal to 10
pack-years exposure).
    For secondary endpoints, objective response rate (ORR) was superior for
IRESSA in the overall population (43 per cent vs. 32 per cent; p =0.0001); for
patients with EGFR mutation positive tumours, ORR was superior for IRESSA
(71.2 per cent vs. 47.3 per cent for IRESSA and carboplatin/paclitaxel
respectively, p = 0.0001), and for patients with EGFR mutation negative
tumours, ORR was superior for chemotherapy (1.1 per cent (one patient) vs.
23.4 per cent for IRESSA and carboplatin/paclitaxel respectively, p = 0.0013).
    The safety profile of IRESSA was generally consistent with its
prescribing information, previous IRESSA studies in the relapsed setting, and
underlying disease. The most commonly reported adverse events with IRESSA are
mild-to-moderate rash and diarrhea.
    Lead Investigator, Professor Tony Mok (Hong Kong Cancer Institute,
Chinese University of Hong Kong) said: "IRESSA is already an established
therapy in Asia, including China and Japan, and is a proven valuable
alternative to single agent chemotherapy in patients with pre-treated advanced
NSCLC. Results from the IPASS study mean that IRESSA (a single once-daily oral
tablet) offers a potential new standard of care in the first-line treatment of
patients with EGFR mutation positive tumours."
    In July 2009, the European Commission granted marketing authorization for
IRESSA for the treatment of adults with locally advanced or metastatic NSCLC
with EGFR mutation positive tumours across all lines of therapy. Outside of
Europe, IRESSA is approved in 36 countries for the treatment of patients with
locally advanced or metastatic NSCLC who have been pre-treated with
chemotherapy. AstraZeneca is in consultation with relevant authorities around
the world to discuss the potential use of IRESSA in first-line therapy.
    In Canada, IRESSA was approved in late 2003 for third-line therapy of
locally advanced or metastatic NSCLC. In 2006, it was restricted to only those
patients already benefiting from IRESSA and whose tumours were EGFR expression
status positive or unknown(2). The IPASS study results have been shared with
Health Canada.

    
    NOTES TO EDITORS

    About IRESSA

    -   Mode of Action: IRESSA is an EGFR-TKI (epidermal growth factor
        receptor-tyrosine kinase inhibitor), which targets and blocks the
        activity of the EGFR-TK, an enzyme that regulates intracellular
        signalling pathways implicated in cancer cell proliferation and
        survival. Growth factor signalling has been identified as a key
        driver of tumour growth and spread in a wide range of cancers.

    -   IRESSA (250 mg) is a once-daily oral therapy.

    -   IRESSA has a well-established, generally well-tolerated side effect
        profile and is not typically associated with the cytotoxic side-
        effects commonly seen with chemotherapy. The most commonly seen
        side-effects of IRESSA are mild-to-moderate rash and
        diarrhea(3),(4),(5).

    -   It is the only targeted therapy that has proven non-inferiority for
        overall survival relative to chemotherapy in patients with pre-
        treated advanced NSCLC(6).

        To date, the number of patients who have taken IRESSA is over
        300,000 around the world.

    About lung cancer

    -   Over 1.35 million new cases of lung cancer are diagnosed every year
        and nearly 1.2 million people die as a result of this devastating
        disease - more than breast, colon and prostate cancer combined(7).

    -   In 2009, an estimated 23,400 Canadians will be diagnosed with lung
        cancer and 20,500 will die of it. Lung cancer remains the leading
        cause of cancer death for both men and women(8).

    -   If lung cancer is detected at early stages, before it has spread to
        other organs or lymph nodes, around half of patients can survive for
        five years or more. However, few lung cancers are found at this early
        stage and it is normally diagnosed at the advanced stage, when five
        year survival falls to approximately 15 per cent(9).
    

    AstraZeneca on personalized healthcare

    AstraZeneca is committed to the development of personalized healthcare
(PHC) to improve clinical outcomes for patients. Approximately 10 per cent of
AstraZeneca drug projects in clinical development are testing a PHC strategy
and every new project carries out a systematic assessment to determine whether
a PHC approach is appropriate. Linking therapies to diagnostics and tools may
deliver superior outcomes through patient selection, improved dosing or
disease definition. PHC requires knowledge of patients' individual
characteristics and the way in which their disease has developed to deliver
more effective therapy. AstraZeneca uses many technologies to predict
biomarkers, including: gene expression, protein expression, gene sequence
variation, tumour gene mutation, gene copy number and imaging.

    About AstraZeneca Canada Inc.

    AstraZeneca is a leading global pharmaceutical company with an extensive
product portfolio spanning six major therapeutic areas: gastrointestinal,
cardiovascular, infection, neuroscience, oncology, and respiratory.
AstraZeneca's Canadian headquarters are located in Mississauga, Ontario, with
a state-of-the-art drug discovery centre based in Montreal, Quebec. For more
information, visit the company's website at www.astrazeneca.ca.

    
    References
    ------------------
    (1) Mok TS, Wu Y-L, Thongprasert S, et al. Gefitinib or carboplatin-
        paclitaxel in pulmonary adenocarcinoma. N Eng J Med 2009;
    (2) AstraZeneca Canada Inc. Iressa Product Monograph.
    http://www.astrazeneca.ca/documents/ProductPortfolio/IRESSA_PM_en.pdf
    (3) Fukuoka M, Yano S, Giaccone G et al. Multi-institutional randomized
        phase II trial of gefitinib for previously treated patients with
        advanced non-small-cell lung cancer (The IDEAL 1 Trial) (corrected).
        J Clin Oncol 2003;21(12):2237-2246.
    (4) Kris MG, Natale RB, Herbst RS et al. Efficacy of gefitinib, an
        inhibitor of the epidermal growth factor receptor tyrosine kinase, in
        symptomatic patients with non-small cell lung cancer: a randomized
        trial. JAMA 2003; 290(16):2149-2158.
    (5) Frampton JE, Easthope SE. Gefitinib: a review of its use in the
        management of advanced non-small-cell lung cancer. Drugs 2004;
        64(21):2475-2492.
    (6) Kim, ES et al. "Gefitinib versus docetaxel in previously treated
        non-small-cell lung cancer (INTEREST): a randomized phase III
        trial." The Lancet. 2008. 372: p.1809-1818.
    (7) Ferlay, J. et al. GLOBOCAN 2002: Cancer Incidence, Mortality and
        Prevalence Worldwide. IARC CancerBase No. 5. version 2.0. Lyon: IARC
        Press, 2004.
    (8) Canadian Cancer Society. Lung Cancer Statistics. Accessed at
http://www.cancer.ca/Canada
wide/About%20cancer/Cancer%20statistics/Stats%20at%20a%20glance/Lung%20cancer.
aspx?sc_lang=en
        Accessed August 2009.
    (9) Bepler G.Lung cancer epidemiology and genetics. J Thorac Imaging
        1999; 14(4):228-234.
    





For further information:

For further information: Stephanie Batcules, Communications Manager,
Oncology, AstraZeneca Canada, (905) 615-6849,
stephanie.batcules@astrazeneca.com; Lynn Bessoudo, Andrea Rosebrugh, NATIONAL
Public Relations, (416) 848-1426, (416) 848-1456, lbessoudo@national.ca,
arosebrugh@national.ca


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