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ARTICLE | Clinical News

Amgen reports Phase III PFS data for AMG 386

June 13, 2013 12:44 AM UTC

Amgen Inc. (NASDAQ:AMGN) said once-weekly trebananib ( AMG 386) plus paclitaxel met the primary endpoint of improving median progression-free survival (PFS) vs. placebo plus paclitaxel in the Phase III TRINOVA-1 trial to treat recurrent ovarian, primary peritoneal and fallopian tube cancer (7.2 vs. 5.4 months, p<0.001). Amgen said that a pre-planned interim analysis of the secondary overall survival (OS) endpoint showed a trend in favor of trebananib. Final OS data are expected to mature next year. The double-blind, international trial enrolled over 900 women with recurrent partially platinum-sensitive or platinum-resistant ovarian cancer, primary peritoneal cancer or fallopian tube cancer.

TRINOVA-1 is the first of three Phase III trials evaluating trebananib in ovarian cancer. Data from the Phase III TRINOVA-2 trial evaluating trebananib plus doxorubicin for recurrent epithelial ovarian, primary peritoneal or fallopian tube cancer are expected next year, while data from the Phase III TRINOVA-3 trial of trebananib plus paclitaxel and carboplatin as first-line treatment of epithelial ovarian, primary peritoneal or fallopian tube cancer are expected in 2016. Trebananib is a recombinant Fc-peptide fusion protein (peptibody) targeting angiopoietins. ...