IDEAYA Biosciences, Inc. (IDYA) Monday announced positive interim data from a Phase 2 study evaluating darovasertib as neoadjuvant treatment for uveal melanoma (UM).
Neoadjuvant therapy is given to a patient before the main treatment, to increase the chances of success of main treatment.
In the study, treatment with darovasertib has shrunk tumor by more than 30 percent in about 49 percent of patients. Further, an eye preservation rate of 61 percent was observed for enucleation patients.
The company also said it had a successful Type C meeting with the FDA which supports initiation of a potential registrational study. IDEAYA plans to commence a Phase 3 study in neoadjuvant UM patients following finalization of the clinical protocol with the FDA.
"The successful FDA Type C meeting provides darovasertib a potential registrational path in neoadjuvant UM, using primary clinical endpoints of eye preservation and time to vision loss, with no detriment to Event-Free-Survival (EFS) in the treatment arms as a secondary endpoint. Based on the highly promising preliminary clinical efficacy and manageable safety profile observed with darovasertib and the high unmet medical need of neoadjuvant UM, we are excited to advance darovasertib rapidly to a registrational trial in this indication," said Darrin Beaupre, Chief Medical Officer, IDEAYA Biosciences.
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