Selumetinib: Phase II data

Researchers at the Memorial Sloan Kettering Cancer Center reported data from an open-label, North American Phase II trial in 98 patients with metastatic uveal melanoma showing that twice-daily 75 mg oral selumetinib met the primary endpoint of improving median PFS vs. temozolomide (15.9 vs. 7 weeks, p=0.0005). Additionally, 4- and 6-month PFS rates for selumetinib were 43.1% and 22.9%, respectively, vs. 8.5% and 5.7% for temozolomide. Selumetinib missed the secondary endpoint of improving median OS vs. temozolomide (10.8 vs. 9.4 weeks, p=0.4). Additionally, 50% of patients receiving selumetinib experienced tumor regression compared to 0% for placebo. Patients whose tumors progressed on temozolomide could cross over to receive selumetinib. The trial was sponsored by the National Cancer Institute (NCI). Data were presented at the American Society of Clinical Oncology meeting in Chicago. The researchers plan to conduct a confirmatory trial in about 100 patients, but did not disclose details. AstraZeneca could not be reached for comment. ...