Servier, an independent international pharmaceutical group governed by a foundation, and IDEAYA Biosciences, Inc., a precision medicine oncology company, have announced an exclusive license agreement to bring darovasertib, a promising treatment for a rare eye cancer, to patients worldwide.

Under the agreement, Servier will obtain the regulatory and commercial rights for darovasertib in all territories outside the United States. IDEAYA will retain its rights for darovasertib in the United States. Darovasertib, a potent and selective protein kinase C (PKC) inhibitor, is being developed to broadly address primary and metastatic uveal melanoma (UM).

“At Servier, our mission is to deliver transformative therapies to patients with significant needs. Our collaboration with IDEAYA is a significant step to make darovasertib the potential first-in-class treatment available to uveal melanoma patients worldwide,” said Arnaud Lallouette, Executive Vice-President Global Medical and Patient Affairs at Servier.

He further added, “Today, there are limited treatment options, and there is an urgent need to improve patient outcomes. We look forward to leveraging our global oncology network and expertise in developing oncology-targeted therapies to make this groundbreaking treatment accessible to patients across the globe.”

Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences, said, “Darovasertib addresses a significant unmet need, and we are thrilled to partner with Servier to globally develop it as a potential standard-of-care for uveal melanoma patients worldwide. This partnership enables IDEAYA and Servier to accelerate the global development of darovasertib across three Phase 3 registrational trials, aiming to improve patient outcomes in the neoadjuvant, adjuvant and metastatic settings.”

Daniel Simon, Chief Business Officer, IDEAYA Biosciences, added, “We believe Servier's global footprint and proven track record in bringing novel therapies to patients in Europe and other key territories outside of the US will ensure that this potentially life-changing treatment reaches as many patients as possible.”

Darovasertib is currently being evaluated in multiple global clinical trials. These include a Phase 2/3 randomised trial evaluating darovasertib in combination with crizotinib in first-line patients with HLA-A2-negative metastatic uveal melanoma (UM), for which the median progression-free survival readout is anticipated from year-end 2025 to Q1 2026, and a Phase 3 randomised trial evaluating neoadjuvant darovasertib as a monotherapy in primary UM, independent of HLA status. IDEAYA and Servier will target to launch a global Phase 3 randomised clinical trial in 2026 to evaluate adjuvant darovasertib in primary UM, also in both HLA-A2-negative and -positive patients.

Uveal melanoma (UM) is a rare and aggressive form of eye cancer that originates in the uveal tract, which includes the iris, ciliary body, and choroid. Despite its rarity, it poses significant risks due to its potential to metastasise to other parts of the body, particularly the liver. Current treatment options include radiation therapy, surgical removal of the tumour, or removal of the eye (enucleation) in severe cases.

Darovasertib has received US FDA (Food and Drug Administration) Breakthrough Therapy Designation as neoadjuvant therapy in enucleation-recommended primary UM and Fast Track designation for darovasertib in combination with crizotinib in adult patients with metastatic UM. Darovasertib has also been designated as an Orphan Drug by the US FDA in UM, including in metastatic UM.

Under the terms of the agreement, IDEAYA will receive an upfront payment of USD 210 million and be eligible for up to USD 100 million in regulatory approval-based milestone payments and up to USD 220 million in commercial milestone payments, as well as double-digit royalties on net sales in all territories outside of the United States. Servier will be responsible for the regulatory and commercial activities for darovasertib in all territories outside the United States. IDEAYA and Servier will collaborate on the development of darovasertib and share the associated costs.