Media Release
Basel, 11 May 2004
Phase
III Xeloda colon cancer study (X-Act) meets primary endpoint
Complete data to be
presented at ASCO, 2004
Roche announced today the successful conclusion
of a large international phase III study comparing Xeloda with standard intravenous 5-FU/LV in the adjuvant
treatment of early stage colon cancer. Oral Xeloda was proven to be at least equivalent to intravenous
5-FU/LV, meeting the primary end-point of the trial.
Professor
Jim Cassidy (University of Glasgow, UK) has submitted the data of this phase III trial for presentation
at the upcoming annual meeting of the American Society of Clinical Oncology (ASCO) in New Orleans in
June.
William M. Burns, Head of Roche’s Pharmaceuticals Division said,
“We believe that the new Xeloda data will be important to patients treated for early stage colon cancer,
and Roche will submit the study results to global regulatory authorities. Adjuvant therapy is a significant
new opportunity for Xeloda, which will further strengthen the Roche oncology portfolio.”
In
2000, colorectal cancer was the third most commonly reported cancer with 945,000 new cases worldwide.
It is estimated that over 50% of people diagnosed with colorectal cancer will die of the disease, and
it is one of the most common cancers in developed countries
1
.Roche in Oncology
Within the last five years the Roche Group has become the world’s leading provider of anti-cancer treatments, supportive care products and diagnostics. Its oncology business includes an unprecedented four marketed products with survival benefit: Herceptin, MabThera, Xeloda and Avastin which has been launched in the US recently, treat a range of malignancies such as breast cancer, non-Hodgkin’s lymphoma and colorectal cancer. Other key products include NeoRecormon (anaemia in various cancer settings), Bondronat (prevention of skeletal events in breast cancer and bone metastases patients, hypercalcemia of malignancy), Kytril (chemotherapy and radiotherapy-induced nausea and vomiting) and Roferon-A (leukaemia, Kaposi's sarcoma, malignant melanoma, renal cell carcinoma). Roche’s cancer medicines generated sales of more than 6 billion Swiss francs in 2003.
In a recent phase III study Tarceva met its primary endpoint of improving overall survival in patients with non-small cell lung cancer.
Roche is developing new tests, which will have a significant impact on disease management for cancer patients in the future. With a broad portfolio of tumour markers for prostate, colorectal, liver, ovarian, breast, stomach, pancreas and lung cancer, as well as a range of molecular oncology tests, we will continue to be the leaders in providing cancer focused treatments and diagnostics.
Roche Oncology has four research sites (two in the US, Germany and Japan) and four Headquarter Development sites (two in the US, UK and Switzerland).
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche is number one in the global diagnostics market, the leading supplier of pharmaceuticals for cancer and a leader in virology and transplantation. As a supplier of products and services for the prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche employs roughly 62,000 people in 150 countries. The Group has alliances and research and development agreements with numerous partners, including majority ownership interests in Genentech and Chugai.
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Reference
1
World Health Organisation. Globocan 2000: Cancer Incidence, Mortality and Prevalence Worldwide. 2000