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Investor Update

Basel, 23 September 2009

Adding Xeloda® to standard chemotherapy before surgery helps to eradicate tumours in patients with early breast cancer

New Phase III study highlights clinical benefit of adding Xeloda to epirubicin and docetaxel in neoadjuvant setting

Results from the ABCSG 24 trial presented today at the joint 15th ECCO and 34th ESMO 2009 congress, Berlin, Germany showed that the addition of  Xeloda (capecitabine) to anthracycline- and taxane-containing regimens prior to surgery (neoadjuvant therapy) led to complete eradication of the tumour in 24% of women with HER2-positive or HER2-negative early breast cancer. The increased efficacy seen obtained by adding Xeloda was measured by an increase in the pathological complete response (pCR) rate from 16% to 24% (hazard ratio of 0.58, p=0.02). This is an important finding since the proportion of women whose tumour completely disappears when treated with standard chemotherapy1 for HER2-positive or HER2-negative early breast cancer is typically less than 20% (range 6–18%).1

“These new data show that adding capecitabine to epirubicin and docetaxel neoadjuvant regimens when treating women with early breast cancer, results in increased efficacy compared to epirubicin and docetaxel alone. This new data could lead to improvements in treatment for women with early stages of the disease as the increased efficacy may result in prolonged overall survival,” said Professor Günther Steger, Division of Oncology, Department of Internal Medicine I, Medical University of Vienna, General Hospital Vienna, Vienna, Austria.

The ABCSG 24 trial, conducted by the Austrian Breast and Colorectal Cancer Study Group, included 536 patients with biopsy-proven operable breast cancer who were scheduled to receive neoadjuvant treatment. It was designed to assess the impact of six cycles of epirubicin, docetaxel and Xeloda (EDC) compared with six cycles of epirubicin and docetaxel (ED). In addition to demonstrating an increase in pCR rates, the results also support the recently published data from a large adjuvant phase III trial (FinXX)1,2 Several other studies of neoadjuvant combination regimens that included Xeloda have also shown positive efficacy results.3,4,5,6,7,8,9 The therapeutic success in these studies was measured as complete pathological response (complete disappearance of tumour cells in the breast and in the lymph nodes), which is a strong predictor for long-term survival.1,10

“Xeloda has already proven its efficacy and tolerability in the treatment of advanced breast cancer. These important results from the ABCSG collaborative group highlight the potential role of Xeloda in the treatment of early breast cancer,” said William M. Burns, CEO Pharmaceuticals Division of Roche.  

Three other studies of Xeloda in adjuvant breast cancer treatment presented at the joint 15th ECCO and 34th ESMO congress include:

  • Reimer, T. Adjuvant ICE Study: A prospective, multi-centre, controlled, open-label, randomized phase III trial of ibandronate (I) with or without capecitabine (X) in elderly patients (pts) with early breast cancer (GBG 32)
  • Lluch, A. Adjuvant CIBOMA/2004-01: a randomised phase III trial assessing adjuvant capecitabine (X) maintenance therapy after standard chemotherapy for triple-negative early breast cancer (EBC)
  • Loibl, S. Pegfilgrastim on day 2 vs. day 4 within the prospective, multi-centered GAIN study: A phase III trial to compare ETC vs. EC-TX and ibandronate vs. observation in patients with node-positive primary breast cancer (GBG 33)

Xeloda is an innovative oral chemotherapy drug that is a powerful and effective treatment option which has been shown to significantly lengthen survival in women with advanced breast cancer11,12 and has been approved for the treatment of metastatic breast cancer for over 10 years.  In addition, as Xeloda is taken as a tablet, patients can take it in the comfort of their own home, while offering them the freedom to carry on with their lives as normally as possible.

Breast cancer is the second most common cancer in the world and the most common cancer among women.13 There are 1.1 million new cases of female breast cancer each year worldwide. 13 Despite recent advances, there is still an unmet need in the treatment and management of early breast cancer with relapse occurring in approximately 30–50% of patients, depending on individual risk factors, even after chemotherapy. 14

About the ABCSG study

The primary aim of the ABCSG-24 study was to evaluate the influence of six cycles of epirubicin, docetaxel and capecitabine (EDC) compared with six cycles of epirubicin and docetaxel (ED) in terms of the achievable rate of pathological complete responses (pCR) at the time of surgery in women with early breast cancer.

Between November 2004 and November 2008, 536 patients with biopsy-proven operable breast cancer who were scheduled to receive neoadjuvant treatment were recruited to the study.

Results to date show:

  • 24.0% pCR for the Xeloda containing treatment arm vs 16.0% pCR without Xeloda  (hazard ratio of 0.58; p=0.02)
  • Side effects of ED are increased with the addition of Xeloda, but side effects of the EDC regimen are well managed  (94% of patients completing all six cycles of EDC compared with 96% completing six cycles for ED alone)

About Xeloda (capecitabine)

Xeloda (capecitabine), is a highly effective targeted oral chemotherapy offering patients a survival advantage when taken on its own or in combination with other anticancer drugs.  Xeloda uniquely activates the cancer-killing agent 5-FU (5-fluorouracil) directly inside the cancer cells so avoiding damage to healthy cells.  Xeloda tablets can be taken by patients in their own home, reducing the number of hospital visits.

Licensed and marketed by Roche in more than 100 countries worldwide, Xeloda has over 11 years proven clinical experience providing an effective and flexible treatment option to over 1.8 million people with cancer. Xeloda is currently approved in:

Metastatic Colorectal Cancer

  • Monotherapy first-line (US & EU) – 2001
  • In combination with any chemotherapy in all lines of treatment with or without Avastin (EU/RoW) - 2008

Metastatic Breast Cancer

  • Monotherapy first-line in patients with tumours resistant to other chemotherapy drugs such as paclitaxel and anthracyclines – (US) 1998 and (EU) 2002
  • In combination with docetaxel in patients whose disease has progressed following iv chemotherapy with anthracyclines – (US) 2001 and (EU) 2002
  • In patients with inoperable or recurrent breast cancer – (Japan) 2003

Adjuvant Colon Cancer

  • Monotherapy (US & EU) – 2005
  • Monotherapy (Japan) - 2007

Advanced Gastric Cancer

  • First-line treatment (South Korea) - 2002
  • In combination with platinum-based chemotherapy first-line (EU) – 2007

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 to provide 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: www.roche.com.

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

1) Kaufmann M, von Minckwitz G, Smith R, et al: International expert panel on the use of primary (preoperative) systemic treatment of operable breast cancer: Review and recommendations. J Clin Oncol 2003;21:2600-2608
2) Significant improvement in recurrence-free survival (RFS) when capecitabine (X) is integrated into docetaxel (T) 5-FU + epirubicin + cyclophosphamide (CEF) adjuvant therapy for high-risk early breast cancer (BC): interim analysis of the FinXX-trial. Presented at the San Antonio Breast Cancer Symposium, December 2008 (abstract # 82)
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