Ideaya upsizes neoadjuvant darovasertib plans

Last September Ideaya Biosciences revealed phase 3 plans for its lead project darovasertib in neoadjuvant uveal melanoma, and now the group has disclosed that the study, due to start this half, will seek to enrol 520 patients rather than its previous estimate of 400. As expected, the trial will involve two cohorts: patients undergoing enucleation (removal of the eyeball) or brachytherapy (localised radiotherapy). The primary endpoints will be eye preservation in the enucleation group, and the proportion of patients with vision loss in the brachytherapy arm. Ideaya has also now clarified that vision loss will be defined as 15 or more letters lost on the early treatment diabetic retinopathy study (ETDRS) scale. Darovasertib, a PKC inhibitor, will be dosed at 300mg twice daily. The company said it might be able to submit the enucleation cohort data to regulators earlier than the brachytherapy arm, but didn’t give any estimate of timelines. Darovasertib is already in a potentially registrational phase 2/3 trial, Dar-UM-2, in first-line metastatic HLA-A2-negative uveal melanoma; median progression-free survival data are expected this year. Ideaya plans to first seek approval in this genetic niche, before expanding into HLA-A2-positive patients.

Pivotal trials of Ideaya’s darovasertib

Note: BCVA=best-corrected visual acuity; ETDRS=early treatment diabetic retinopathy study. Source: OncologyPipeline, company statements & clinicaltrials.gov.