OptimUM-10: neoadjuvant darovasertib in uveal melanoma

In this video, Dr Manon Mossakowski speaks with Dr Meredith McKean to discuss OptimUM-10, an ongoing phase III trial evaluating neoadjuvant darovasertib in patients with primary non-metastatic uveal melanoma at high risk of metastatic progression.¹

Darovasertib is an oral protein kinase C inhibitor, targeting a pathway activated downstream of GNAQ/GNA11 alterations, which are present in most uveal melanomas. Earlier neoadjuvant data from the phase II OptimUM-09 suggested that darovasertib may reduce tumour size, potentially allowing eye preservation in patients otherwise planned for enucleation and radiation dose reduction in patients treated with plaque brachytherapy.

OptimUM-10 includes two cohorts: patients with medium-sized tumours planned for plaque brachytherapy and patients with large tumours planned for enucleation. In each cohort, patients are randomised to primary local therapy or up to six cycles of neoadjuvant darovasertib before local therapy.

The primary endpoints are vision preservation in the plaque brachytherapy cohort and eye preservation in the enucleation cohort. Secondary endpoints include response rate, event-free survival and safety.