Date: 2012-04-05
Type of information: Results
phase: 3
Announcement: results
Company: Sanofi (France) Regeneron Pharmaceuticals (USA)
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: metastatic androgen-independent prostate cancer
Therapeutic area: Cancer Oncology
Country:
Trial
details: The main objective of the multinational VENICE study (VEGF Trap Administered with Docetaxel in metastatic androgen-independent prostate cancer) was to evaluate the efficacy and safety of the investigational agent ZALTRAP® (aflibercept) concentrate for intravenous infusion as a first-line treatment in combination with docetaxel and prednisone.
The trial randomized 1,224 patients with metastatic androgen-independent prostate cancer to receive either docetaxel, prednisone and ZALTRAP or docetaxel, prednisone and placebo.
The primary endpoint was improvement in overall survival. Secondary endpoints included Prostate Specific Antigen (PSA) measurement, pain measurement, progression-free survival, and safety.
Latest
news: Sanofi and Regeneron Pharmaceuticals have announced the results from the Phase III VENICE trial evaluating the addition of the investigational agent ZALTRAP to a regimen of docetaxel and prednisone for the first-line treatment of metastatic androgen-independent prostate cancer.
The study did not meet the pre-specified criterion of improvement in overall survival (OS). The safety profile was generally consistent with previous studies of ZALTRAP in combination with docetaxel. The companies are conducting a detailed analysis of the VENICE data, and full results will be presented at an upcoming medical meeting.
