Regeneron Pharmaceuticals, Inc. announced that the Phase 3 VENICE clinical trial evaluating the investigational agent Zaltrap (aflibercept) in the first-line treatment of men with castrate resistant prostate cancer will continue to completion as planned. They have not been asked to make any modifications due to efficacy or to safety concerns. This decision is based on the recommendation of an Independent Data Monitoring Committee (IDMC) following a planned interim analysis.
According to George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer of Regeneron and President of Regeneron Research Laboratories, . “We look forward to the final results of this trial next year in the hope of providing a new therapy for patients with metastatic prostate cancer.”
About the VENICE Study
The main objective of the multinational VENICE study (Aflibercept in Combination with Docetaxel in castrate resistant prostate cancer) is to evaluate the efficacy and safety of Zaltrap as a first-line treatment in combination with docetaxel and prednisone in 1,200 men with with castrate resistant prostate cancer. The primary endpoint is improvement in overall survival. Secondary endpoints include Prostate Specific Antigen (PSA) measurement, pain measurement, progression-free survival and safety. The trial is fully enrolled with 1,224 randomized patients, and final results are anticipated in 2012.
Zaltrap (aflibercept), also known as VEGF Trap, is an investigational broad-spectrum angiogenesis inhibitor with a unique mechanism of action. This fully-human fusion protein binds all forms of Vascular Endothelial Growth Factor-A (VEGF-A), as well as VEGF-B and placental growth factor (PIGF), additional angiogenic growth factors that appear to play a role in tumor angiogenesis and inflammation. It has been shown to bind VEGF-A, VEGF-B and PlGF with higher affinity than their native receptors.
Sanofi Oncology and Regeneron are collaborating on an oncology development program, combining the investigational agent Zaltrap (aflibercept) with common chemotherapy regimens in the treatment of patients with advanced cancers. In addition to VENICE, the program includes one Phase 3 trial and one Phase 2 trial:
• Velour study (Phase 3): second-line treatment in combination with the Folfiri regimen (irinotecan-5-fluorouracil-leucovorin) in subjects with metastatic colorectal cancer (mCRC) previously treated with an oxaliplatin-based regimen. Positive results demonstrating significantly improved survival with Zaltrap were presented June 25 during the ESMO World Congress on Gastrointestinal Cancer; the associated abstract (#0-0024) was published in the June 2011 supplement to Annals of Oncology.
• AFFIRM study (Phase 2): first-line treatment in mCRC in combination with folinic acid (leucovorin), 5-fluorouracil, and oxaliplatin (FOLFOX). Results are anticipated in the second half of 2011.
Zaltrap, is a potential new treatment for castrate resistant prostate cancer that is on the horizon.
Joel T Nowak, M.A., M.S.W.