AGO-OVAR 16: A phase III study to evaluate the efficacy and safety of pazopanib (PZ) monotherapy versus placebo in women who have not progressed after first line chemotherapy for epithelial ovarian, fallopian tube, or primary peritoneal cancer—Overall survival (OS) results.

5518Background: AGO-OVAR 16 study investigated PZ, an oral multi-kinase inhibitor of VEGFR-1, -2, -3, PDGFR-α and -β and c-Kit. This study was designed to test efficacy, safety and tolerability of PZ maintenance after first-line chemotherapy in newly diagnosed advanced ovarian cancer (AOC). The results of final analysis of OS following last patient last visit (LPLV) after prespecified futility criteria were met during 3rd OS interim analysis (IA) are reported. Methods: Inclusion criteria: Patients with histologically confirmed AOC; prior treatment of surgical debulking and at least five cycles of platinum-taxane chemotherapy with no evidence of progression; and no bulky disease or disease requiring imminent therapy. Nine hundred and forty patients were randomized in a 1:1 ratio to receive either 800 mg PZ once daily or placebo for up to 24 months unless disease progression, toxicity, withdrawal of consent, or death. The Primary endpoint (investigator assessed progression-free survival (PFS) was met (J Cli...