On April 26, 2011, sanofi-aventis and Regeneron Pharmaceuticals announced positive results for the Phase III VELOUR trial, which compared ZALTRAP to a placebo during FOLFIRI chemotherapy.
Detailed results will be available at an upcoming medical conference.
The VELOUR trial enrolled 1,226 people with colorectal cancer that had spread and who had already had their cancer get worse on an initial treatment with oxaliplatin. Patients came from the United States and throughout the world.
They were randomly assigned to
- FOLFIRI (irinotecan, leucovorin, and infusional 5-FU) plus ZALTRAP
- FOLFIRI plus a placebo
The primary outcome was overall survival time.
Secondary outcomes included:
- Time before tumors grew or new tumors appeared (progression free survival).
- Percentage of patients whose tumors shrank while on treatment (response rate).
- Treatment side effects.
- Ability of treatment to provoke an immune system response (immunogenicity).
Aflibercept or VEGF trap is a specially developed protein that can block the development of new blood vessels as it circulates in the blood stream or in the spaces between blood vessels near tumors. It acts on two different vascular endothelial growth factors (VEGF) as well as placental growth factor (PIGF).
In announcing the results of VELOUR, Debasish Roychowdhury, M.D., Senior Vice President and Head of the Global Oncology Division at sanofi-aventis said,
We are pleased with the results of the ZALTRAP Phase III study in this group of patients.We are committed to bringing ZALTRAP to patients with advanced colorectal cancer and maximizing the therapeutic potential of this unique and exciting medicine.
George D. Yancopoulos, M.D., Ph.D., President of Regeneron Research Laboratories, added,
These findings are exciting given the limited second-line treatment options for patients with metastatic colorectal cancer. Based upon these positive findings, we and sanofi-aventis plan to submit regulatory applications for marketing approval to the U.S. Food and Drug Administration and the European Medicines Agency in the second half of the year.
The AFFIRM Phase II clinical trial is studying whether ZALTRAP can improve progression-free and overall survival time in combination with FOLFOX chemotherapy as an initial (first-line) treatment for metastatic colorectal cancer. It has completed enrolling patients, and results are expected later this year.
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VEGF-Trap image courtesy of sanofi-aventis.