Investor Presentaiton
18
Darovasertib Monotherapy in (Neo)adjuvant Primary Uveal Melanoma
Clinical Experience: Observed 100% of Patients (9 of 9) with Ocular Tumor Reduction^
IDEAYA Phase 2 and IST ongoing to evaluate Darovasertib
Current Treatment Approach following diagnosis of UM
depends on tumor size and location:
Enucleation in Large Tumors (~ 20%)
Radiation in Small/Medium Tumors (~80%)
Plaque Brachytherapy
Clinical Experience in UM and MUM Patients
Neoadjuvant UM
Enucleation Cohort ** (n=6)
Treatment Duration (mo)
MUM
Intact Primary Ocular Tumors* (n=3)
Plaque
Placement
lodine-125 Plaque Surgery, UCLA
Poor Vision (≤20/200) occurs in about 70%-80% of patients
with UM (including enucleation)
Neoadjuvant / Adjuvant Systemic Therapy goals:
Avoid Nucleation → Save the Eye
Reduce Tumors and Radiation Dose → Protect Vision
Reduce Occurrence of Metastasis → Save Lives
Paradigm Shifting Opportunity to Broadly Impact UM,
with annual incidence of ~8,000 - 10,000 patients in US, EU
+ Neoadjuvant UM or MUM patients treated with Darovaserib + Crizotinib
Best Ocular Tumor Response (%)
1
1
0%
-10%
-20%
-30%
-40%
Treatment Duration (mo)
Γ
I
2
4
1
4
7
0.5
11
I
0%
-10%
-20%
+
-30%
I
-60%
Eye
Saved
-40%
-50%
-60%
I
-70%
I
+
-80%
|
Eye
-90%
Saved
-100%
-50%
-70%
-80%
-90%
I CASE STUDIES
+ Darovasertib + Crizotinib
+
Each Reported Case has shown a Reduction in Size of Ocular Eye Lesion **
Data by investigator assessment as of April 15, 2023, from (i) NADOM IST courtesy of Professor Anthony Joshua, MBBS, PhD, FRACP, St. Vincent's Hospital, with update as of June 22, 2023 for monotherapy NADOM IST patient who was
spared enucleation (ii) Compassionate Use Case; for NADOM IST, by initial protocol the first 3 neoadjuvant UM patients were required to stop treatment at ~1 month; IST protocol was subsequently amended to treat up to 6 months
^ Best Ocular Tumor Response based on maximal % reduction in measured Apical Height or Longest Basal Diameter (LBD)
* Ocular tumor shrinkage measured by investigator assessment by either MRI, ultrasound, CT-scan, or PET scan (0.5 month scan for MUM patient, SUV Max% tumor response)
IDEA A
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