Date: 2011-07-07
Type of information: Initiation of preclinical development
phase: 3
Announcement: results of a planned interim analysis
Company: Regeneron Pharmaceutical (USA) Sanofi (France)
Product: Zaltrap® (aflibercept)
Action
mechanism: fusion protein/VEGF receptor. Aflibercept is a recombinant fusion protein, consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 and formulated as an iso-osmotic solution for intravitreal administration. Eylea® acts as a soluble decoy receptor that binds VEGF-A and placental growth factor (PlGF) and thereby can inhibit the binding and activation of these cognate VEGF receptors.
Disease: hormone-refractory metastatic prostate cancer
Therapeutic area: Cancer - Oncology
Country: International study
Trial
details: The main objective of the multinational VENICE study (Aflibercept in Combination with Docetaxel in Metastatic Androgen Independent 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 patients with hormone-refractory metastatic 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.
Latest
news: Regeneron Pharmaceuticals has announced that the Phase 3 VENICE clinical trial evaluating the investigational agent Zaltrap® (aflibercept) in the first-line treatment of patients with androgen-independent (hormone-refractory) metastatic prostate cancer will continue to completion as planned, with no 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. Regeneron and Sanofi are collaborating in the development of Zaltrap® in oncology. Both Regeneron and Sanofi management and staff remain blinded to the interim study results.
