A randomized phase 2 study of etaracizumab, a monoclonal antibody against integrin αvβ3, ± dacarbazine in patients with stage IV metastatic melanoma

摘要: BACKGROUND: The alpha v beta 3 (αvβ3) integrin is involved in intracellular signaling regulating cell proliferation, migration, and differentiation important for tumor-induced angiogenesis. METHODS: This phase 2, randomized, open-label, 2-arm study was designed to capture safety data evaluate the antitumor efficacy of etaracizumab (Abegrin), an IgG1 humanized monoclonal antibody against αvβ3 integrin, patients with previously untreated metastatic melanoma. The objective whether ± dacarbazine had sufficient clinical activity warrant further a trial. RESULTS: One hundred twelve were randomized receive alone (N = 57) or + 55). Safety acceptable infusion-related, gastrointestinal, metabolic reactions being most common adverse events (AEs). majority AEs grade 1 2 severity both arms; not considered serious, except cardiovascular (myocardial infarction, atrial fibrillation) thromboembolic events, which occurred 5 patients, respectively. None etaracizumab-alone arm 12.7% achieved response. median duration response 4.2 months. Stable disease rate, time progression (TTP), progression-free survival (PFS) appeared be similar between treatment arms. 45.6% 40.0% arm. Median TTP PFS 1.8 months 2.5 2.6 arm, overall 12.6 9.4 arm. CONCLUSIONS: The results arms this unlikely result clinically meaningful improvement over alone. Cancer 2010. © 2010 American Society.