Important Progress in Treatment of Early and Late Stage Breast Cancer With
Herceptin, Avastin and T-DM1

    
    -   Roche to Present new Results That Could Offer a Better Future to
        Women With Early and Very Advanced Breast Cancer, at the CTRC-AACR
        San Antonio Breast Cancer Symposium
    

BASEL, Switzerland, Dec. 9 /CNW/ - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that new 5 year follow-up data from two pivotal studies with Herceptin(R) (trastuzumab) in early breast cancer; key results from a study of Avastin(R) (bevacizumab) in the second-line treatment of advanced breast cancer and strong data on the use of trastuzumab-DM1 (T-DM1), the first antibody-drug conjugate in development for very advanced HER2-positive breast cancer, will all be presented during the CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) from 9 to 13 December 2009.

"Breast cancer is the most common cancer among women worldwide with more than one million new cases diagnosed every year and nearly 400,000 deaths, so it is vital that we continue to provide more treatment options," said William M. Burns, CEO of Roche Pharma. "The much anticipated data on Herceptin, Avastin and the investigational drug T-DM1 will be welcomed by physicians treating women with early and very advanced stages of breast cancer as it will offer them more choices for fighting this devastating disease."

Two Herceptin studies in early breast cancer, five year follow up data (N9831, BCIRG 006)

    
    -   5-years of follow-up data will be presented from these pivotal phase
        III studies that have already shown efficacy in patients when adding
        12 months of Herceptin to standard therapy.

    -   Both studies were seeking to answer questions the medical community
        has been contemplating regarding the best way of giving their
        patients Herceptin treatment.
    

Avastin RIBBON-2 study, second-line treatment data

    
    -   Avastin is well established as a first-line treatment for women with
        advanced breast cancer. RIBBON-2 will report on the benefits of
        Avastin in combination with commonly used chemotherapies in the
        second-line setting where currently the only option is subsequent
        chemotherapy.
    

T-DM1 4374 study in very advanced breast cancer

New data from a phase II study (TDM4374) in a very advanced patient population who have exhausted other treatment options will be presented. This follows on from another phase II study (TDM4258) that was presented at ASCO 2009 which showed encouraging results in women with advanced HER2-positive breast cancer.

In addition, further data from the phase II study BO17929 will be presented, demonstrating that the combination of pertuzumab and trastuzumab shows efficacy in patients with HER2-positive advanced breast cancer whose disease had progressed during prior treatment with Herceptin plus chemotherapy.(i) The data, which suggest that combining pertuzumab and trastuzumab may offer an effective new treatment option to patients with HER2-positive advanced breast cancer, have been accepted as a poster presentation on Saturday 12 Dec, 17:30 - 19:30, Poster Session 5, Exhibit Halls A-B.

Details of key studies being presented:

    
    Herceptin N9831 study

    The study is part of the official SABCS press programme on Saturday
    12 Dec., 08:00 hrs.

    Dr E. Perez,    Results of chemotherapy alone, with          Oral
    et al           sequential or concurrent addition of         presentation
                    trastuzumab in the NCCTG N9831               Saturday 12
                    HER2-positive adjuvant breast cancer         Dec, 15:00,
                    trial.                                       General
                                                                 Session 6,
                                                                 Exhibit Hall
                                                                 D.

    Herceptin BCIRG 006 study

    Dr. D. Slamon,  Phase III randomized trial comparing         Oral
    et al           doxorubicin and cyclophosphamide followed    presentation
                    by docetaxel (AC à T) with doxorubicin and   Saturday 12
                    cyclophosphamide followed by docetaxel and   Dec, 09:45,
                    trastuzumab (AC à TH) with docetaxel,        General
                    carboplatin and trastuzumab (TCH) in         Session 5,
                    Her2neu positive early breast cancer         Exhibit Hall
                    patients: BCIRG 006 study.                   D.

    Avastin RIBBON-2 study

    The study is part of the official SABCS press programme on Friday
    11 Dec., 12:30 hrs.

    Dr. A.          RIBBON-2: A randomized, double-blind,        Oral
    Brufsky, et al  placebo-controlled, phase III trial          presentation
                    evaluating the efficacy and safety of        Friday 11
                    bevacizumab in combination with              Dec, 15:00,
                    chemotherapy for second-line treatment of    General
                    HER2-negative metastatic breast cancer.      Session 4,
                                                                 Exhibit Hall
                                                                 D.

    T-DM1 4374 study

    Dr. I. Krop,    A phase II study of trastuzumab-DM1          Poster
    et al           (T-DM1), a novel HER2 antibody-drug          presentation
                    conjugate, in patients previously treated    Saturday 12
                    with lapatinib, trastuzumab, and             Dec, 07:00 -
                    chemotherapy.                                09:00.
                                                                 Poster
                                                                 Discussion
                                                                 7, Ballroom
                                                                 B.
    

The above mentioned studies and data represent the latest results of clinical research for each treatment and are not necessarily part of the indicated licence in each country. For detailed label information, visit the website of your health authority or the EMEA website http://www.emea.europa.eu/

In HER2-positive breast cancer, increased quantities of the HER2 protein are present on the surface of the tumour cells. This is known as 'HER2-positivity'. High levels of HER2 are present in a particularly aggressive form of the disease which responds poorly to chemotherapy. Research shows that HER2-positivity affects approximately 20-30 percent of women with breast cancer.(ii)

The 2009 CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) takes place from 9 to 13 December 2009. Full details can be found at http://www.sabcs.org/.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche's personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients.

In 2008, Roche had over 80,000 employees worldwide and invested almost 9 billion Swiss francs in R&D.

The Group posted sales of 45.6 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: http://www.roche.com.

All trademarks used or mentioned in this release are protected by law.

Additional information

    
    -   Roche SABCS materials:
        http://www.roche.com/media/events/med-sabcs2009.htm

    -   More about Roche's work in oncology:
        http://www.roche.com/media_backgrounder/media_oncology.htm

    -   Oncology backgrounders:
        http://www.roche.com/media_backgrounder/media_oncology.htm

    -   Roche.com section on PHC:
        http://www.roche.com/research_and_development/phc_in_r_d.htm

    -   http://www.thenewsmarket.com

    -   Video clips and backgrounder on products:
        http://www.roche.com/med-cor-2009-05-15.htm


    References
    ----------
    (i)  Baselga J. et al., Abstract 1004. American Society of Clinical
         Oncology Annual Meeting 2007.

    (ii) Harries M, Smith I. The development and clinical use of trastuzumab
         (Herceptin). Endocr Relat Cancer 9: 75-85, 2002.
    

SOURCE Roche

For further information: For further information: Roche Group Media Relations: Phone: +41-61-688-8888, e-mail: basel.mediaoffice@roche.com, Daniel Piller (Head), Alexander Klauser, Martina Rupp, Claudia Schmitt, Nina Schwab-Hautzinger

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