Selumetinib: Phase II data

An open-label, U.S. Phase II trial in 69 patients with unresectable metastatic, recurrent or locally advanced STS who received <=2 prior chemotherapy regimens showed that there was no significant difference in median PFS, the primary endpoint, between twice-daily oral selumetinib as monotherapy and selumetinib plus temsirolimus (1.9 vs. 2.1 months). In a prespecified subgroup of patients with leiomyosarcoma (n=21), selumetinib plus temsirolimus significantly improved median PFS vs. selumetinib alone (3.7 vs. 1.8 months, p=0.01). In all patients, the 4-month PFS rate was 24% in both treatment arms. In the leiomyosarcoma subgroup, the 4-month PFS rate was 0% for selumetinib alone vs. 50% for selumetinib plus temsirolimus. The trial was sponsored by NIH’s NCI. Data were presented at the American Society of Clinical Oncology meeting in Chicago. ...