Date: 2011-03-10
Type of information: Results
phase: 3
Announcement: results
Company: Sanofi-Aventis (France) Regeneron Pharmaceuticals (USA)
Product: aflibercept (VEGF Trap)
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: non-small cell lung cancer (NSCLC)
Therapeutic area: Cancer - Oncology
Country:
Trial
details: The VITAL study was a multinational, randomized, double-blind trial comparing aflibercept versus placebo in combination with docetaxel patients with locally advanced or metastatic non-squamous NSCLC who have failed one platinum-based therapy. The study enrolled 913 patients who were randomized to receive intravenous (IV) docetaxel 75 mg/m2 plus either IV placebo or IV aflibercept 6 mg/kg every three weeks until disease progression, unacceptable toxicity, patient's refusal or further treatment. The primary objective of the study was to demonstrate improvement in overall survival with the combination of aflibercept and docetaxel compared with placebo and docetaxel.
Latest
news: Sanofi-aventis and Regeneron Pharmaceuticals announced results from the Phase III VITAL trial evaluating the investigational agent aflibercept (VEGF Trap) for the second-line treatment of non-small cell lung cancer (NSCLC). The data showed that adding aflibercept to the chemotherapy drug docetaxel did not meet the pre-specified criteria for the primary endpoint of improvement in overall survival compared with a regimen of docetaxel plus placebo (HR=1.01, CI: 0.868 to 1.174). The addition of aflibercept to docetaxel demonstrated activity as measured by key secondary endpoints of the study: progression free survival (PFS) (HR=0.82, CI: 0.716 to 0.937) and an overall objective response rate (ORR) of 23.3 percent in the aflibercept arm compared to 8.9 percent in the placebo arm. The companies will conduct a detailed analysis of the efficacy and safety results of the VITAL study. Full results will be presented at an upcoming medical meeting.
Two other Phase III trials of aflibercept in metastatic colorectal cancer and hormone-refractory metastatic prostate cancer are underway to determine the clinical potential of aflibercept for patients with these advanced cancers. These studies are :
- VELOUR: Second-line treatment for metastatic colorectal cancer in combination with 5-fluorouracil, leucovorin and irinotecan (FOLFIRI). Final results are anticipated during the first half of 2011.
- VENICE: First-line treatment for hormone-refractory metastatic prostate cancer in combination with docetaxel and prednisone (Phase III). An interim analysis is expected to be conducted by an Independent Data Monitoring Committee in mid 2011; final results are anticipated in 2012.
Another phase II study is currently running, AFFIRM: First-line treatment in metastatic colorectal cancer in combination with 5-fluorouracil, leucovorin and oxaliplatin (FOLFOX) (Phase II). Final results are expected during the second half of 2011.
