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Additional Study With Avastin in Metastatic Colorectal Cancer Shows Significant Increase in Progression-free Survival
BERLIN, GERMANY -- November 27, 2003 -- Roche and Genentech 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.
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SOURCE: Roche
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