The phase 3 SUMIT study of Selumetinib in combination with Dacarbazine for the treatment of patients with metastatic uveal melanoma did not meet its primary endpoint of progression free survival.
This combination therapy showed an adverse event profile generally consistent with current knowledge of the safety profiles of Dacarbazine and Selumetinib.
Selumetinib is a MEK inhibitor in late-stage development, with a primary phase 3 program in second-line KRAS-mutant advanced non-small cell lung cancer in combination with Docetaxel.
Selumetinib inhibits the MEK enzyme in the RAS/RAF/MEK/ERK pathway in cancer cells to prevent the tumor from growing.
Selumetinib is also being investigated in a phase 3 study in differentiated thyroid cancer and in a phase 2 registration study in patients with neurofibromatosis type 1.
The Selumetinib in Uveal Melanoma Investigator Trial ( SUMIT ) is a randomized, double-blind, placebo controlled trial being carried out in 45 Centers, across 11 countries.
Uveal melanoma is an orphan disease in which cancer cells grow in the tissues of the eye. It is the most common primary intraocular malignancy in adults and comprises 5% of all melanomas.
There are currently no effective treatments for advanced uveal melanoma; Selumetinib was granted Orphan Drug Designation by the FDA ( Food and Drug Administration ) in recognition of the need for new, safe and effective therapies for the disease. ( Xagena )
Source: Array BioPharma, 2015