Positive interim Phase II data for darovasertib

Shares of California, USA-based precision medicines IDEAYA Biosciences (Nasdaq: IDYA) were down 6.3% at $32.5 mid-morning after it revealed what is described as “positive” developments for its darovasertib.

The company announced interim Phase II clinical trial data for darovasertib in neoadjuvant uveal melanoma (UM) and a successful Food and Drug Administration (FDA) Type C meeting on registrational trial design for regulatory approval in neoadjuvant UM.

"Darovasertib has demonstrated compelling preliminary clinical efficacy and a favorable AE profile in the neoadjuvant UM setting, with approximately 49% of patients demonstrating greater than 30% tumor shrinkage and importantly approximately 61% eye preservation rate for enucleation patients. The primary clinical endpoints supported by discussions with the FDA of eye preservation and time to vision loss are clinically meaningful for neoadjuvant UM patients, and darovasertib has the potential to provide a new standard of care in this setting," said Dr Carol Shields, chief of the Ocular Oncology Service at Wills Eye Hospital and Professor of Ophthalmology at Thomas Jefferson University.