AstraZeneca today announced that 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. A full evaluation of the data is ongoing.
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 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.
Antoine Yver, Head of Oncology, Global Medicines Development at AstraZeneca said: "Selumetinib is supported by a strong development program with different scientific rationale in multiple tumor types as both monotherapy and in alternative combinations. The findings from SUMIT have no impact on the other studies and we look forward to presenting the data in due course."
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