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Cancer Resources > Cancer News > Cancer News from Reuters > Reuters Cancer News > 2003 > May
Anti-angiogenetic drug plus chemo prolongs colorectal cancer survival
Last Updated: 2003-05-20 9:49:23 -0400 (Reuters Health)
NEW YORK (Reuters Health) - The combination of Genentech's anti-angiogenic antibody bevacizumab and chemotherapy against metastatic colorectal cancer extended life by more than had been expected in a phase III trial, the company said on Monday.
Detailed results from the study were not immediately available. The company said they would be submitted to the annual meeting of the American Society of Clinical Oncology at the end of the month.
"The magnitude of the benefit observed far exceeded what the study was designed to demonstrate," the company said. "The trial also met the secondary endpoints of progression-free survival, response rate and duration of response."
"Showing a survival benefit is very rare," said Meirav Chovav, an analyst at investment bank UBS Warburg. "This is going to transform the treatment of solid tumors, and it's obviously going to transform Genentech."
The drug, which Genentech will market as Avastin, is designed to inhibit vascular endothelial growth factor (VEGF).
"The data from this important phase III trial, which show that treatment with Avastin and chemotherapy resulted in improved survival, highlights a potentially new way to treat patients with metastatic colorectal cancer," said Dr. Susan D. Hellmann, Genentech's executive vice president, Development and Product Operations, and chief medical officer.
"This study also provides the first phase III clinical validation of the long-pursued 'anti-angiogenic' hypothesis," she said.
In the study, 800 previously untreated patients with metastatic colorectal cancer were randomized to receive either Avastin plus the Saltz chemotherapy regimen (5-FU/Leucovorin/CPT-11) or the Saltz regimen plus placebo.
A third arm of the study treated 100 patients with Avastin plus 5-FU/Leucovorin chemotherapy. This arm was dropped, as pre-specified, once the safety of the Saltz regimen was established.
The company said adding the new drug to chemotherapy was well tolerated.
Bleeding, thrombosis, asymptomatic proteinuria and hypertension were identified in phase II studies as possible safety events, but only grade 3 hypertension was clearly increased in this phase III study. However, gastrointestinal perforation, although uncommon, may be increased by the addition of bevacizumab to chemotherapy.
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