Based on the results from this study, the U.S. Food and Drug Administration (FDA) approved AvastinTM in February 2004, to be used in combination with intravenous 5-Fluorouracil-based chemotherapy as first-line treatment for patients with metastatic cancer of the colon or rectum. AvastinTM is the first FDA-approved cancer therapy designed to inhibit angiogenesis. Colorectal cancer is 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.2
"The New England Journal of Medicine publication of the Avastin pivotal study is significant because it is the first published trial of its kind," said Herbert I. Hurwitz, M.D., the study's lead author and assistant professor, Division of Medical Oncology, Duke University Medical Center. "The results are impressive because the survival improvement was observed in a broad group of patients enrolled in the trial."
Patients who received AvastinTM combined with chemotherapy survived for 20.3 months on average, almost five months more than the group of patients treated with chemotherapy alone, who survived for an average of 15.6 months. This research is significant as it is the largest improvement in survival time reported in a Phase III clinical study for colorectal cancer that can be attributed to the addition of a single targeted therapy to conventional chemotherapy. Progression free survival was 10.6 months in the Avastin plus chemotherapy arm, compared to 6.2 months in the chemotherapy alone arm. In the subgroup of patients who received second-line treatment with oxaliplatin, the median duration of overall survival was 25.1 months in the group given IFL plus AvastinTM and 22.2 months in the group given IFL plus placebo. Response rate and duration of response were also improved with AvastinTM.
AvastinTM is the first treatment that inhibits angiogenesis – the growth of a network of blood vessels that supply nutrients and oxygen to cancerous tissues. AvastinTM targets a naturally occurring protein called VEGF (Vascular Endothelial Growth Factor), a key mediator of angiogenesis, thus interfering with the blood supply that is essential for the growth of the tumour and its spread throughout the body (metastasis). It also promotes the effective delivery of chemotherapy within the tumour.
As this mechanism may be relevant in a number of malignant tumours, manufacturers Roche and Genentech are presently investigating the potential benefit of Avastin's use in a number of other forms of cancer, including non-small cell lung cancer, pancreatic, breast and renal (kidney) cell carcinoma. Large clinical trials are also underway in patients with colorectal cancer that has not spread (adjuvant therapy).
"Publication of these results is testament to the significance of AvastinTM as a scientific and medical advance in the treatment of cancer," said Dr. Stefan Manth, Head of Roche Oncology. "Following FDA approval earlier this year, we are working closely with the European regulatory authorities to bring Avastin, the first treatment of its kind, to patients as quickly as possible."
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.
Based on a positive phase III study Tarceva, the first and only EGFR-targeted drug, showed improved 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 65,000 people in 150 countries. The Group has alliances and R&D agreements with numerous partners, including majority ownership interests in Genentech and Chugai.
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Notes to Editors:
IFL is a standard chemotherapy combination treatment.
The combination of Avastin and chemotherapy was well tolerated, with only grade 3 hypertension (> 180mmHg / > 110mmHg, which was manageable using standard oral medication) clearly more frequent in the Avastin-containing arm of the trial.
References:
1. Hurwitz H, Fehrenbacher L, Novotny W, et al. Addition of bevacizumab (rhuMab-VEGF) to bolus IFL in the first-line treatment of patients with metastatic colorectal cancer: results of a randomized Phase III trial. New England Journal of Medicine 2004;350(23)
2. World Health Organisation. Globocan 2000: Cancer Incidence, Mortality and Prevalence Worldwide. 2000
Journal
New England Journal of Medicine