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Fresh data from the OptimUM trials, presented at ESMO 2026, show that darovasertib — alone or paired with crizotinib — is showing real promise across multiple stages of uveal melanoma. Response rates reached 36.4% in treatment-naive patients, and neoadjuvant use helped over half of patients requiring eye removal preserve their eye. These findings could reshape how this rare, hard-to-treat cancer is managed.
Data from three OptimUM trials presented at ESMO 2026 are building a compelling case for darovasertib as a foundational therapy in uveal melanoma — a rare eye cancer with very limited treatment options. In the phase 2 OptimUM-01 trial, darovasertib plus crizotinib achieved a confirmed objective response rate (ORR) of 22.1% overall and 36.4% in treatment-naive patients, with a disease control rate of 80.2% and 90.9%, respectively. Median overall survival reached 27.1 months in treatment-naive patients — a notable benchmark for this difficult-to-treat cancer.
In the OptimUM-09 neoadjuvant study, darovasertib monotherapy before local treatment showed striking results: 85.7% of patients had tumor shrinkage, and among those needing enucleation (eye removal), 56.9% were ultimately able to preserve their eye. Patients with at least 20% tumor reduction had a 93.9% eye preservation rate.
Key Takeaways:
Why it matters: Uveal melanoma has historically had no approved systemic therapies in the primary disease setting. These results suggest darovasertib could not only extend survival in metastatic disease but also preserve quality of life — including vision — for patients with primary tumors.
