IDEAYA reports Q2 2026 results, darovasertib trial hits primary endpoint
OptimUM-02 met its progression-free survival goal in metastatic uveal melanoma as IDEAYA files an NDA under FDA's real-time review program, backed by $1.24 billion in cash.
IDEAYA Biosciences said its registrational OptimUM-02 trial, presented at ASCO in a late-breaking oral session, enrolled 313 first-line HLA*A2:01-negative metastatic uveal melanoma patients as of a January 23, 2026 cutoff, randomized 2:1 to darovasertib plus crizotinib versus an investigator's choice arm reflecting real-world treatment1. The trial's primary endpoint was median progression-free survival as assessed by blinded independent central review1, and patients on the darovasertib combination showed a statistically significant improvement in median PFS of 6.9 months versus 3.1 months in the control arm, with a hazard ratio of 0.42 and a p-value below 0.00011. Overall survival data remained immature at the cutoff, though the company noted an early trend favoring the combination, with a formal interim OS analysis expected in mid-2027.1
IDEAYA said its NDA filing is underway under the FDA's real-time oncology review program, with completion expected in the second half of 20261. Separately, following a Type C meeting with the FDA, IDEAYA and partner Servier initiated a global Phase 3 trial called OptimUM-11, testing the combination in about 450 adjuvant-setting patients randomized 1:1 to 12 months of treatment or observation, with relapse-free survival as the primary endpoint1.
On other pipeline fronts, the company announced a clinical collaboration with Roche to test IDE892 alongside Roche's pan-RAS drug RG6505 in MTAP-deleted, RAS-mutant pancreatic cancer, targeting a Phase 1 trial start in the second half of 20261. IDEAYA also said it is planning to share initial clinical data from its own global Phase 1/2 study of IDE849 in small-cell lung cancer and neuroendocrine carcinoma later this year1, while partner Hengrui will present updated Phase 1 data on the same drug at ESMO.
Financially, IDEAYA held approximately $1.24 billion in cash, cash equivalents and marketable securities as of June 30, 2026, and said its cash runway guidance into 2030 remains unchanged1.
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