IDEAYA presents positive darovasertib trial data for uveal melanoma at ESMO 2026
IDEAYA Biosciences and partner Servier disclosed results from three darovasertib studies at the ESMO Congress. In the phase‑2 OptimUM‑01 expansion, treatment‑naïve metastatic patients achieved a median progression‑free survival of 7.4 months and a median overall survival of 27.1 months. OptimUM‑02 showed a median PFS of 6.9 months versus 3.1 months for investigator’s choice therapy in first‑line HLA‑A*02:01‑negative disease. OptimUM‑09 reported a 57% eye‑preservation rate and a 66% reduction in planned radiation dose in primary uveal melanoma patients.
Why it matters
The data suggest darovasertib could become a new standard for metastatic and primary uveal melanoma, potentially expanding the market for IDEAYA’s oncology pipeline. The company plans to file a new drug application in the second half of 2026, which could trigger regulatory review and commercial launch if approved.
Key facts
- 1OptimUM‑01 enrolled 101 HLA‑A*02:01‑positive metastatic uveal melanoma patients with a median follow‑up of 10.4 months. prnewswire.com
- 2Treatment‑naïve patients in OptimUM‑01 had a median progression‑free survival of 7.4 months and a median overall survival of 27.1 months. investing.com
- 3OptimUM‑02 first‑line HLA‑A*02:01‑negative patients experienced a median PFS of 6.9 months versus 3.1 months for investigator’s choice therapy. investing.com
- 4OptimUM‑09 enrolled 116 primary uveal melanoma patients; 57% eye‑preservation was observed in the enucleation cohort and 66% had reduced radiation dose in the plaque brachytherapy cohort. investing.com
- 5IDEAYA expects to complete submission of a new drug application for darovasertib plus crizotinib in the second half of 2026. investing.com
Summary written by AlphAI AI Desk from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.