Date: 2011-04-26
Type of information: Initiation of preclinical development
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: second-line treatment of metastatic colorectal cancer
Therapeutic area: Cancer Oncology
Country:
Trial
details: The VELOUR study was a multinational, randomized, double-blind trial comparing FOLFIRI in combination with either Zaltrap® or placebo in the treatment of patients with mCRC after failure of an oxaliplatin-based regimen. The study enrolled 1,226 patients with mCRC who previously had been treated with an oxaliplatin-based regimen. The primary endpoint was animprovement in overall survival. The study had 90 percent power to detect a 20 percent reduction in the hazard rate for overall survival using a two-sided log-rank test. Secondary endpoints included progression-free survival, response to treatment, and safety.
Latest
news: Sanofi and Regeneron Pharmaceuticals have announced that the Phase III VELOUR trial evaluating Zaltrap® (aflibercept), also known as VEGF Trap, in combination with the FOLFIRI chemotherapy regimen [folinic acid (leucovorin), 5-fluorouracil, and irinotecan] versus a regimen of FOLFIRI plus placebo met its primary endpoint of improving overall survival in the second-line treatment of metastatic colorectal cancer (mCRC).
The most frequent adverse events reported with Zaltrap® in combination with FOLFIRI were diarrhea, asthenia/fatigue, stomatitis and ulceration, nausea, infection, hypertension, gastrointestinal and abdominal pains, vomiting, decreased appetite, decreased weight, epistaxis, alopecia, and dysphonia.
Full results will be presented at an upcoming medical meeting.
The two partners plan to submit regulatory applications for marketing approval to the FDA and the EMA in the second half of the year.
