New therapy option for advanced HER2 breast cancer approved in Canada



    
    TYKERB(TM) is the first oral, once-a-day HER2 targeted therapy approved
    by Health Canada
    

    MISSISSAUGA, ON, May 26 /CNW/ - Women living with HER2 positive breast
cancer now have a new treatment option for the first time in almost ten years.
Health Canada has approved Tykerb(TM) (lapatinib ditosylate) tablets for use
in combination with an oral chemotherapy, capecitabine (Xeloda(R)), for the
treatment of patients with advanced or metastatic breast cancer whose tumours
overexpress HER2 (ErbB2) and who have progressed following prior therapies
including taxanes, anthracyclines and trastuzumab (Herceptin(R)). HER2
positive breast cancer is an aggressive form of the disease that affects
approximately 20 per cent of breast cancer patients.(1)
    "Today marks an important milestone," said Dr. Kathleen Pritchard, Senior
Scientist at Sunnybrook Odette Cancer Centre, and Professor of Medicine at the
University of Toronto. "Tykerb is a new way to treat HER2 positive breast
cancer that gives women with advanced HER2 positive breast cancer another
weapon in the fight to control their disease, where before they had no other
options."
    Tykerb(TM) slows the progression of advanced breast cancer in patients
whose disease has progressed following treatment with other cancer therapies.
Women with HER2 (ErbB2) positive breast cancer are at a greater risk of
disease progression and death compared to women with tumours that do not
overexpress this protein.(2)
    Tykerb(TM) has a novel mechanism of action that is different from current
licensed targeted therapies for HER2 positive disease. It is a small molecule
that is administered orally and works by getting inside the cancer cell and
inhibiting the EGFR (ErbB1) and HER2 (ErbB2) receptors, which are involved in
the growth and proliferation of some cancers.
    "In 2004, when my breast cancer came back, my doctor said I was out of
treatment options," says Cecile Comeau, a Canadian HER2 positive breast cancer
patient. "He then suggested I join a clinical trial for a new oral therapy, I
had nothing to lose. That decision has meant everything to me, and to my
family."
    "Tykerb's approval means a new option in our arsenal in the fight against
HER2 positive breast cancer and we look forward to the day when it is made
available to Canadian women in every province," says Diana Ermel, President,
Canadian Breast Cancer Network. "Dedication to research and new therapies like
this one provides women with more tools they need to fight their disease."
    "The approval of Tykerb is very important for women with HER2 positive
breast cancer - both now and in the future," says Virginia Yule, Executive
Director, Willow Breast Cancer Support Canada. "When new treatments become
available, they provide more options for physicians and women to deal with
their breast cancer."

    
    About Breast Cancer
        -  In 2009, an estimated 22,700 Canadian women will be diagnosed with
           breast cancer.(3)
        -  For Canadian women, breast cancer is the second leading cause of
           cancer mortality.(4)
        -  Breast cancer is the most common cancer and cause of cancer death
           in women aged 20 - 59, accounting for 37 per cent of new cases and
           22 per cent of deaths.(5)
        -  One in nine women is expected to develop breast cancer during her
           lifetime. One in 28 will die of it.(6)
        -  HER2 (otherwise known as ErbB2) positive breast cancer is an
           aggressive form of cancer that hits women in their prime.
           Approximately 20 per cent of women with breast cancer overexpress
           the HER2 (ErbB2) protein.(7) Since it is a particularly aggressive
           form of cancer, women with HER2 (ErbB2) positive breast cancer are
           at a greater risk of disease progression and death compared to
           women with breast cancer tumors that do not overexpress HER2
           (ErbB2).(8) The five-year relative survival rate is significantly
           lower among women with a more advanced stage (stage III or IV) of
           cancer at diagnosis at 59% and 26% respectively.(9)
        -  GSK has a comprehensive clinical trial program that is actively
           studying Tykerb(TM) tablets in other breast cancer settings and
           other cancers to better identify patient populations that may
           respond to therapy. These include the earlier stages of HER2
           (ErbB2) positive breast cancer,(10),(11),(12) inflammatory breast
           cancer,(13) brain metastases,(14) as well as head and neck, and
           gastric cancers.(15),(16)

    Clinical Trials
    The approval was based on a pivotal phase III trial (EGF100151) in which
women with locally advanced or metastatic HER2 positive breast cancer whose
disease had progressed following prior treatment with anthracyclines, taxanes
and trastuzumab were given either the combination of Tykerb(TM) and
capecitabine, or capecitabine alone. Tykerb(TM) in combination with
capecitabine was shown to increase the median time to progression compared to
capecitabine alone. There was a consistent benefit in time to progression
(TTP) by both unblinded investigator and blinded independent assessment,
although the magnitude of TTP by independent assessment was likely
overestimated.
        -  By investigator assessment, median TTP was increased from 18.3
           weeks to 23.9 weeks when taken in combination with capecitabine
           versus capecitabine alone.
        -  By independent assessment, median TTP was increased from 18.6
           weeks to 27.1 weeks in the Tykerb(TM) with capecitabine compared
           to the capecitabine alone.
    In Canada more than 50 investigators have been involved in Tykerb(TM)
breast cancer clinical trials to date involving over 290 patients in nine
provinces.
    

    The most common adverse events during therapy with Tykerb(TM) plus
capecitabine were gastrointestinal (diarrhea, nausea and vomiting), skin
toxicities (hand foot syndrome and rash) and fatigue. The majority of adverse
events and laboratory abnormalities were mild to moderate in severity. The
most common grade 3 and 4 adverse reactions were diarrhea and hand foot
syndrome. Tykerb(TM) has also been associated with cardiac toxicity, pulmonary
toxicity and hepatotoxicity.(17)

    
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    About GlaxoSmithKline Inc.
    GlaxoSmithKline Inc. - one of the world's leading research-based
pharmaceutical, vaccine and healthcare companies - is committed to improving
the quality of human life by enabling people to do more, feel better and live
longer. In Canada, GlaxoSmithKline is a top 15 investor in research and
development, contributing more than $156 million in 2008 alone. GSK is
designated a Caring Company by Imagine Canada, and is consistently recognized
as one of the 50 best companies to work for in Canada. For company information
please visit, www.gsk.ca.

    
    References
    -------------------------------------------------------------------------
    (1)  Ross JS, Slodkowska EA, Symmans WF, et al. The HER-2 receptor and
         breast cancer : ten years of targeted anti-HER-2 therapy and
         personalized medicine. The Oncologist 2009;14:320-368.
    (2)  Slamon DJ, Clark GM, Wong SG, Levin WJ, Ullrich A, McGuire WL. Human
         breast cancer: correlation of relapse and survival with
         amplification of the HER-2/neu oncogene. Science 1987:235:177-87.
    (3)  Canadian Cancer Society's Steering Committee: Canadian Cancer
         Statistics 2009. Toronto: Canadian Cancer Society, 2009.
    (4)  Ibid.
    (5)  Ibid.
    (6)  Ibid.
    (7)  Ross JS, Slodkowska EA, Symmans WF, et al. The HER-2 receptor and
         breast cancer: ten years of targeted anti-HER-2 therapy and
         personalized medicine. The Oncologist 2009;14:320-368.
    (8)  Slamon DJ, Clark GM, Wong SG, Levin WJ, Ullrich A, McGuire WL. Human
         breast cancer: correlation of relapse and survival with
         amplification of the HER-2/neu oncogene. Science 1987:235:177-87.
    (9)  Canadian Cancer Statistics 2007. Canadian Cancer Society. Page 84.
    (10) Moy B, et al. Phase III study of lapatinib after completion of
         adjuvant chemotherapy in trastuzumab-naive women with ErbB2-
         overexpressing breast cancer: TEACH Study. Poster presentation, 10th
         International Conference on Primary Therapy of Early Breast Cancer
         in St Gallen, Switzerland. Thursday 17th March 2007.
    (11) Piccart M. et al. A Phase III Study for HER2-Overexpressing Early
         Breast Cancer: ALTTO Study. Poster presentation, 10th International
         Conference on Primary Therapy of Early Breast Cancer in St Gallen,
         Switzerland. Thursday 17th March 2007.
    (12) Baselga J. et al. A Phase III Translational Study for HER2-
         Overexpressing Early Breast Cancer: Neo-ALTTO Study. Poster
         presentation, 10th International Conference on Primary Therapy of
         Early Breast Cancer in St Gallen, Switzerland. Thursday 17th March
         2007.
    (13) Kaufman B, Trudeau M, Awada A, et al. Lapatinib monotherapy in
         patients with Her2-overexpressing relapsed or refractory
         inflammatory breast cancer: final results and survival of the
         expanded HER2+ cohort in EGF103009, a phase II study. The Lancet
         Oncology. Published online April 27, 2009. DOI:10.1016/S1470-2045
         (09)70087-7.
    (14) Lin NU, Dieras V, Paul D, et al. Multicenter phase II study of
         lapatinib in patients with brain metastases from HER2-positive
         breast cancer. Clin Cancer Res 2009;15(4):1452-1459.
    (15) El-Hariry, I., Harrington K. et al. A phase I, open label study
         (EGF100262) of lapatinib plus chemoradiation in patients with
         locally advanced squamous cell carcinoma of the head and neck
         (SCCHN). Oral presentation, 1st International Meeting on Innovative
         Approaches in Head & Neck Oncology, Barcelona, Spain. 22nd - 24th
         February 2007.
    (16) Ravaud A, Gardner, R. Hawkins H et al. Efficacy of lapatinib in
         patients with high tumor EGFR expression: Results of a phase III
         trial in advanced renal cell carcinoma (RCC). Journal of Clinical
         Oncology, 2006 ASCO Annual Meeting Proceedings Part I. Vol 24,
         No. 18S (June 20 Supplement) 2006: 4502
    (17) Product Monograph of Tykerb(TM) (lapatinib ditosylate) tablets,
         GlaxoSmithKline Inc., May 2009.
    





For further information:

For further information: Jilda Lazer, Environics Communications Inc.,
(416) 969-2737, jlazer@environicspr.com; Corporate Communications,
GlaxoSmithKline Inc., (905) 819-3363

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