Investor Presentaiton
Darovasertib Clinical & Commercial Strategy in Uveal Melanoma Indication
High Unmet Need and Multiple First-Line Opportunities across the Patient Journey
Indication is the Diagnostic: +95% of UM patients harbor GNAQ/GNA11 or upstream activating
mutation of PKC-signaling, enabling Broad Applicability of Darovasertib in this Indication
HLA-A2-Negative
(~60-65% of UM / MUM)**
No FDA Approved Therapies*
Neoadjuvant UM
Daro
Phase 2
Enucleation
Define
Accelerated
Approval
Daro
Phase 2
Radiation
Define
Accelerated
Approval
Path
Path
No FDA Approved Therapies*
Uveal Melanoma Patient Journey
Adjuvant UM
First-Line MUM
Pretreated MUM
Daro
Phase 2
Define Accelerated
Approval Path
Therapies*
No FDA Approved
Daro + Crizo
Registrational Trial
Accelerated Approval
Daro + Crizo
Target NCCN / Compendia Listing
HLA-A2-Positive
(~35-40% of UM / MUM)**
Target Treatment Duration
Target Clinical Endpoints
Annual Incidence US/EU**
Total Prevalence US/EU**
>6 months
Eye & Vision Preservation
>6 months
Relapse Free Survival
mPFS + ~3 months
ORR, mPFS, MOS
mPFS + ~3 months
ORR, MPFS, MOS
~8-10k
~100k
~8-10k
~100k
~4-5k
~14k
FDA Orphan Drug Designation in Uveal Melanoma+
21
*No FDA approved systemic therapies in multiple UM and MUM indications across the patient journey
**IDEAYA data: HLA-A2-positive and HLA-A2-negative prevalence in MUM based on IDEAYA clinical trial data; US/EU MUM annual incidence and total prevalence based on market research analysis
Orphan Drugs benefit from certain tax credits and may be excluded from certain mandatory price negotiation provisions of the 2022 Inflation Reduction Act
IDEAVA
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