Ideaya Biosciences reported two opposite movements in the same programme on November 3. It completed the submission of its first new drug application to the US Food and Drug Administration, seeking approval of darovasertib combined with crizotinib in metastatic uveal melanoma under the agency’s Real-Time Oncology Review programme. In the same update it stopped enrolment and closed the Phase 3 OptimUM-010 trial in primary uveal melanoma, citing ongoing site activation and enrolment challenges.
The closure is expected to save 100 million to 125 million dollars, which the company will reallocate to other programmes, including potential registrational trials for IDE849 and IDE892. Ideaya said it remains committed to patient access to neoadjuvant darovasertib and plans to submit published data from the Phase 2 OptimUM-09 trial to support inclusion in clinical practice guidelines.
That Phase 2 data, updated at the ESMO congress, covered about 119 patients with primary uveal melanoma. More than 85 percent of patients treated with single agent neoadjuvant darovasertib had tumour shrinkage, with a 57 percent eye preservation rate in the cohort that would otherwise have faced eye removal, and 74 to 79 percent of plaque brachytherapy patients achieving a reduced predicted radiation dose to critical eye structures.
The programme continues on a narrower front. Ideaya and Servier have started the global Phase 3 OptimUM-011 trial of the darovasertib combination in the adjuvant setting in primary uveal melanoma, designed to enrol about 450 patients randomised to 12 months of treatment or observation, with relapse free survival as the primary endpoint. The company holds an R and D day on November 16.