Investor Update
Basel, 26 November 2003
Additional
study with Avastin in metastatic colorectal cancer demonstrates a significant increase in progression-free
survival
Avastin plus chemotherapy also shows trend toward improvement in median
survival - US FDA review and plans for filing Avastin in the EU are on track
Roche and Genentech (NYSE:DNA) today announced that a Phase II study of Avastin (bevacizumab) plus chemotherapy in patients with metastatic colorectal cancer showed a 67 percent prolongation in progression-free survival, which was highly statistically significant. The study also showed a 29 percent improvement in survival in patients who received Avastin plus chemotherapy compared to those receiving chemotherapy alone, but did not achieve statistical significance.
“We’re encouraged that a survival trend was observed and that patients also experienced a statistically significant improvement in progression-free survival, which is very important for patients with metastatic cancer, and consistent with the results of our Phase III trial,” said William M Burns, Head of Roche Pharmaceuticals. “We will continue to work closely with the European regulatory authorities with regards to our plans to file for approval of Avastin in the coming months.”
Results of the pivotal study of Avastin in advanced colorectal cancer were announced earlier this year and demonstrated that Avastin plus another form of chemotherapy, the IFL regime, (5-FU/Leucovorin/CPT-11) improved median survival by approximately five months, compared to patients treated with IFL regime alone (20.3 months vs. 15.6 months). These data will provide the basis for filing for approval of Avastin in the European Union.
About
the study
The Phase II, controlled, multi-centre study enrolled 209 patients.
Unlike the pivotal Phase III study, this study enrolled patients who were not optimal candidates to
receive first-line CPT-11 chemotherapy. Historically, patients ineligible for CPT-11 have a poorer prognosis
and are sicker than patients who are eligible for CPT-11 therapy.
This trial confirms the good safety profile of Avastin that makes it an ideal candidate for combination with fluoropyrimidines – even for advanced colorectal cancer patients unfit to receive more toxic chemotherapeutic regimens.
Roche in Oncology
Within the last five
years Roche has become the world’s leading provider of anti-cancer treatments, supportive care products
and diagnostics. Its oncology business includes an unprecedented three marketed products with survival
benefit; Herceptin, MabThera and Xeloda, treating a range of malignancies - breast cancer, non-Hodgkin’s
lymphoma and colorectal cancer. Other key products include NeoRecormon (anaemia in various cancer settings),
Bondronat (hypercalcemia of malignancy), Roferon-A (leukaemia, Kaposi's sarcoma, malignant melanoma,
renal cell carcinoma) and Kytril (chemotherapy and radiotherapy-induced nausea and vomiting). A total
of 4.5 billion Swiss francs in oncology product sales were recorded for the first nine months of 2003.
Roche’s products in development also promise survival benefit with Avastin. In a recent study Avastin increased survival duration by 30% when combined with first-line chemotherapy for patients with advanced colorectal 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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