Date: 2011-06-06
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: metastatic colorectal cancer
Therapeutic area: Cancer - Oncology
Country: International study
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. The study randomized 1,226 patients with mCRC who previously had been treated with an oxaliplatin-based regimen. Approximately 30 percent of patients in the trial received prior bevacizumab therapy. The primary endpoint was an improvement in overall survival. Secondary endpoints included progression-free survival, response to treatment, and safety.
Latest
news: Sanofi and Regeneron Pharmaceuticals have announced that data showing that the investigational agent Zaltrap® (aflibercept), also known as VEGF Trap, significantly improved survival in previously treated metastatic colorectal cancer patients will be presented at the ESMO World Congress on Gastrointestinal Cancer on June 25, 2011. The abstract (#0-0024) was published in the June 2011 supplement to Annals of Oncology.
Patients with metastatic colorectal cancer (mCRC) previously treated with oxaliplatin were randomized to receive Zaltrap® or placebo in combination with the FOLFIRI regimen (irinotecan-5-fluorouracil-leucovorin). The addition of Zaltrap® to the FOLFIRI regimen significantly improved both overall survival (HR=0.817; p=0.0032) and progression-free survival (HR=0.758; p=0.00007). A similar effect was seen with Zaltrap® therapy whether or not patients had received prior bevacizumab therapy.
Grade 3 or 4 adverse events (AEs) that occurred with a more than 2 percent greater incidence in the Zaltrap® arm than in the placebo arm included diarrhea, asthenia/fatigue, stomatitis/ulceration, infections, hypertension, GI/abdominal pains, neutropenia, neutropenic complications and proteinuria. Deaths on study treatment due to AEs occurred in 2.6 percent of patients in the Zaltrap® arm and in 1.0 percent of patients in the placebo arm.
