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Darovasertib

Phase 3

Uveal Melanoma | Small molecule | Oncology |IDEAYA Biosciences, Inc.|Last Updated: May 6, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment680
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07015190Neoadjuvant Darovasertib in Primary Uveal MelanomaPHASE3 RECRUITING 520 — — Jan 25, 2026Mar 1, 2031May 6, 202694 United States, Australia +19
NCT05907954(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular MelanomaPHASE2 ACTIVE NOT_RECRUITING 160 — — Jul 3, 2023Apr 30, 2030Mar 16, 202618 United States, Australia +5
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Study Endpoints
Primary Endpoints
Cohort 1: To demonstrate that the proportion of subjects with vision loss is lower for subjects in the Treatment Arm vs the Control Arm
Approximately 3 years

Loss of Best Corrected Visual Acuity (BCVA) of ≥ 15 letters using Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA

Cohort 2: To demonstrate the ability to salvage the eye and prevent enucleation in the Treatment Arm
Approximately 2 years

Eye preservation rate

Incidence of Adverse Events (AEs) and significant laboratory abnormalities
from first dose to 28 days after last dose of therapy, approximately 18 months

Treatment emergent adverse events will be summarized by all AEs, all Grade 3-4-5 AEs, all treatment related AEs, all AEs leading to study drug modifications or discontinuations, all SAEs. Lab results will be summarized by change from baseline values, frequency of newly occurring on-treatment Grade 3 or 4 events; worst on-treatment value compared to baseline.

Cohort 1 (enucleation): Number of patients converted from requiring enucleation to radiation
from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 12 months

Rate of eye salvage as determined by the ocular oncologist based on tumor response to neoadjuvant therapy

Cohort 2 (plaque brachytherapy): Estimated change in modeled radiation dose
from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 12 months

Change in modeled radiation dose at critical eye structures before and after neoadjuvant therapy

Cohort 3 (patients with small UM tumors): Number of patients with clinical benefit per protocol-defined UM response criteria
from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 12 months

Proportion of patients with clinical benefit rate (CBR) defined as complete response (CR) + partial response (PR) + stable disease (SD) for ≥ 12 weeks per UM response criteria

Secondary Endpoints
Evaluate tumor response to neoadjuvant IDE196
from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 12 months
Assessment of visual acuity loss
from time of primary local therapy to one year after surgery, approximately 12 months
Rate of local disease recurrence
from date of primary local therapy to end of follow-up, approximately 36 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment ArmEXPERIMENTALDarovasetib followed by definitive primary local therapy (i.e., PB, proton beam radiation, or enucleation)
Control ArmACTIVE_COMPARATORImmediate Primary Local therapy
darovasertibEXPERIMENTALIDE196 (darovasertib) oral open label
Interventions
NameTypeDescription
DarovasertibDRUGDosed orally, twice daily (28-day/ cycle
Primary Local TherapyPROCEDUREPlaque Brachytherapy or Enucleation
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites94

Inclusion Criteria: * Primary non-metastatic uveal melanoma * Able and willing to provide written, informed consent before initiation of any study-related procedures, and in the opinion of the Investigator, to comply with all study requirements * ECOG 0 or 1 * Adequate organ function Exclusion Cri...

Countries:United StatesAustraliaAustriaBelgiumCanadaCzechiaDenmarkEstoniaFranceGermanyGreeceIsraelItalyNetherlandsNew ZealandPolandSlovakiaSloveniaSpainSwitzerlandUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07015190primaryCompletionDate: changed
LOWMay 26, 2026NCT05907954primaryCompletionDate: changed
LOWMay 24, 2026NCT07015190studyFirstPostDate: changed
LOWMay 24, 2026NCT05907954studyFirstPostDate: changed