Dacarbazine Plus Selumetinib: Phase III Results in Metastatic Uveal Melanoma
Posted: Friday, May 11, 2018
The addition of the MEK1/2 inhibitor selumetinib to dacarbazine in a double-blind, randomized phase III trial did not significantly improve progression-free survival in patients with metastatic uveal melanoma, according to research led by Richard D. Carvajal, MD, of Columbia University Medical Center, New York. The study, published in the Journal of Clinical Oncology, noted that researchers had previously found, in a randomized phase II trial, that selumetinib had single-agent activity in patients with this cancer.
In the SUMIT study by Dr. Carvajal and colleagues, 129 patients with uveal melanoma from 29 sites in 11 nations who had no previous systemic treatment took part. They were randomly assigned to receive selumetinib (75 mg twice daily) plus dacarbazine (1,000 mg/m2 intravenously on day 1 of every 21-day cycle; n = 97) or placebo plus dacarbazine (n = 32).
The median time to a progression-free survival (the primary endpoint) in the selumetinib group was 2.8 months versus 1.8 months in the placebo group (P = .32). A secondary endpoint, objective response, was observed in 3% and 0% of selumetinib- and placebo-treated patients, respectively.
Although the safety profile of selumetinib was deemed tolerable, no additional analysis of overall survival, the other projected secondary endpoint, is planned. However, the combination of selumetinib plus paclitaxel in this patient population is being investigated in an ongoing trial.