IDEAYA Biosciences and Servier Announce Data From Three Clinical Trials at ESMO 2026 Supporting the Potential of Darovasertib to Become a Foundational New Therapy for Patients Across the Treatment Journey of Uveal Melanoma
Key Highlights
- ➤OptimUM-01 treatment-naïve patients posted 7.4-month median PFS and 27.1-month median OS
- ➤OptimUM-02 combination delivered 6.9-month median PFS versus 3.1 months for investigator’s choice
- ➤OptimUM-09 showed 57% eye preservation in the enucleation cohort
- ➤OptimUM-09 reduced planned radiation dose for 66% of plaque brachytherapy patients
- ➤IDEAYA expects second-half 2026 NDA submission for darovasertib plus crizotinib
Expert Statements
Yujiro S. Hata, Chief Executive Officer of IDEAYA Biosciences
“These three clinical updates at ESMO continue to support our belief in the potential for darovasertib to address important unmet needs across the uveal melanoma treatment journey”
Yujiro S. Hata, Chief Executive Officer of IDEAYA Biosciences
“In the metastatic setting we believe the data from OptimUM-01 and OptimUM-02 offer strong and consistent evidence for the potential of darovasertib to address the needs of a broad patient population, irrespective of HLA-allele status.”
Yujiro S. Hata, Chief Executive Officer of IDEAYA Biosciences
“In primary disease, longer follow up data from OptimUM-09 continues to highlight the potential of neoadjuvant darovasertib to shrink tumors before primary local treatment to help more patients preserve their eyes and avoid the risk of long-term vision loss.”
Yujiro S. Hata, Chief Executive Officer of IDEAYA Biosciences
“Together, these data advance our vision of establishing darovasertib as a foundational therapy for uveal melanoma.”
Meredith McKean, M.D., MPH, Director of Melanoma and Skin Cancer Research at Sarah Cannon Research Institute
“I am highly encouraged by the OptimUM-01 and OptimUM-02 data being presented at ESMO 2026, which highlights the continued progress being made for patients with metastatic uveal melanoma.”
Meredith McKean, M.D., MPH, Director of Melanoma and Skin Cancer Research at Sarah Cannon Research Institute
“The randomized OptimUM-02 results demonstrate the potential for darovasertib plus crizotinib to establish a new first line standard for patients with HLA-A*02:01-negative disease, while the OptimUM-01 findings reinforce its potential to become a new standard of care for the broader population of patients irrespective of HLA-A*02:01 status and line of therapy.”
Meredith McKean, M.D., MPH, Director of Melanoma and Skin Cancer Research at Sarah Cannon Research Institute
“Together, these data represent a meaningful advancement toward addressing the diverse and significant needs of the metastatic uveal melanoma patient community.”
Marcus O. Butler, M.D., Associate Professor, Princess Margaret Cancer Center
“For patients with primary uveal melanoma, shrinking the tumor before local treatment with neoadjuvant darovasertib could fundamentally change their quality of life by increasing their odds of eye preservation and protecting their long-term quality of vision.”
Marcus O. Butler, M.D., Associate Professor, Princess Margaret Cancer Center
“The additional follow-up data from OptimUM-09 presented at ESMO represents a meaningful potential advance for patients in the primary disease setting, where there are no approved systemic treatment options.”
IDEAYA Biosciences and Servier Announce Data From Three Clinical Trials at ESMO 2026 Supporting the Potential of Darovasertib to Become a Foundational New Therapy for Patients Across the Treatment Journey of Uveal Melanoma PR Newswire
* OptimUM-01 and OptimUM-02 data supports the broad potential of darovasertib plus crizotinib to drive meaningful clinical benefits for patients with metastatic uveal melanoma, irrespective of HLA-A*02:01 allele status or line of therapy * OptimUM-01 data demonstrates encouraging clinical activity from darovasertib combined with crizotinib in both treatment-naïve (7.4 month PFS, 27.1 month mOS, n=13) and heavily pretreated HLA-A*02:01-positive metastatic uveal melanoma, including in 2L patients following tebentafusp * Treatment-naïve patients in OptimUM-01 and OptimUM-02 demonstrate comparable ORR, PFS and DOR in HLA-A*02:01-positive and -negative patients and consistent improvements in ORR and PFS versus investigator's choice of therapy across a range of clinically relevant subgroups * OptimUM-09 continues to demonstrate robust tumor shrinkage in >80% of primary uveal melanoma patients treated with neoadjuvant darovasertib, resulting in a 57% eye preservation rate and 66% of patients achieving a reduced projected dose of radiation to critical eye structures in the enucleation and plaque brachytherapy cohorts, respectively SOUTH SAN FRANCISCO, Calif., Oct. 19, 2026 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, today announced updated clinical data from three ongoing studies evaluating darovasertib in metastatic and primary uveal melanoma (UM) that will be presented at the European Society for Medical Oncology (ESMO) Congress 2026, taking place on October 23–27 in Madrid, Spain. The updates will include Phase 2 expansion data from OptimUM-01 in HLA-A*02:01-positive patients with metastatic uveal melanoma (mUM), subgroup analyses from the registrational Phase 2/3 OptimUM-02 trial in first line (1L) HLA-A*02:01-negative mUM and follow-up data from the Phase 2 OptimUM-09 trial evaluating neoadjuvant darovasertib in patients with primary UM.
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