Anupam Rama

Ben Burnett

Charles Zhu

Joel Beatty

Maury Raycroft

Tim Chiang

Zegbeh Jallah

- IDEAYA Biosciences, Inc. announced positive median overall survival (OS) data from its Phase 1/2 OptimUM-01 trial for the **darovasertib and crizotinib combination** in first-line metastatic uveal melanoma (mUM), reporting a **median OS of 21.1 months** and a **median progression-free survival (PFS) of 7.0 months** in 44 patients, significantly exceeding the historical median OS of approximately 12 months.  **[1676725_0001193125-25-243558_d42028d8k.htm:1]** 
- The company also presented positive Phase 2 data from its OptimUM-09 trial for **neoadjuvant darovasertib** in primary uveal melanoma (UM), demonstrating **83% ocular tumor shrinkage** across 94 evaluable patients and a **57.1% eye preservation rate** in patients initially recommended for enucleation.  **[1676725_0001193125-25-243558_d42028d8k.htm:3]** 
- Darovasertib has received **U.S. Food and Drug Administration Breakthrough Therapy Designation** in the neoadjuvant setting of primary uveal melanoma for enucleation-eligible patients.  **[1676725_0001193125-25-243558_d42028d8k.htm:3]** 
- IDEAYA Biosciences is targeting to report topline median PFS data from its registration-enabling Phase 2/3 trial (OptimUM-02) for the darovasertib and crizotinib combination in metastatic UM by **year-end 2025 to Q1 2026** to support a potential U.S. accelerated approval filing.  **[1676725_0001193125-25-243558_d42028d8k.htm:1]** **[1676725_0001193125-25-243558_d42028d8k.htm:3]**

IDEAYA Biosciences Reports Positive Clinical Data for Darovasertib in Uveal Melanoma

- IDEAYA Biosciences presented positive Phase 2 data from its OptimUM-09 trial for **neoadjuvant darovasertib** in primary uveal melanoma (UM) at ESMO 2025.  **[1676725_20251020SF01416:0]** 
- The trial demonstrated **83%** (78/94) ocular tumor shrinkage, with **54%** (51/94) of patients achieving ≥20% tumor shrinkage.  **[1676725_20251020SF01416:0]** 
- A **57%** (24/42) eye preservation rate was observed in enucleation-recommended patients, increasing to **95%** (19/20) for those with ≥20% tumor shrinkage.  **[1676725_20251020SF01416:0]** **[1676725_20251020SF01416:1]** 
- Darovasertib has received **U.S. FDA Breakthrough Therapy Designation** in the neoadjuvant setting of primary UM for enucleation eligible patients.  **[1676725_20251020SF01416:0]** 
- The company is conducting a Phase 3 trial (OptimUM-10) for darovasertib in neoadjuvant primary UM and expects topline data from its Phase 2/3 trial (OptimUM-02) for metastatic UM by **end of 2025 to Q1'26**.  **[1676725_20251020SF01416:1]**

IDEAYA Biosciences Announces Positive Phase 2 Data for Darovasertib in Primary Uveal Melanoma

- IDEAYA Biosciences announced positive median overall survival (OS) results from its Phase 1/2 OptimUM-01 clinical trial for **darovasertib in combination with crizotinib** as a first-line treatment for metastatic uveal melanoma (mUM).  **[1676725_20251020SF01431:0]** 
- The combination demonstrated a median OS of **21.1 months**, which compares favorably to the reported historical median OS of approximately 12 months for this condition.  **[1676725_20251020SF01431:0]** 
- Additional efficacy data included a median progression-free survival (PFS) of **7.0 months**, a confirmed overall response rate (ORR) of **34%**, and a disease control rate (DCR) of **90%**.  **[1676725_20251020SF01431:0]** 
- The combination exhibited **manageable tolerability**, and the company anticipates reporting median PFS data from the ongoing Phase 2/3 OptimUM-02 trial by **year-end 2025 to Q1 2026** to support a potential U.S. accelerated approval filing.  **[1676725_20251020SF01431:0]**

IDEAYA Biosciences Reports Positive Overall Survival Data for Darovasertib Combination in Metastatic Uveal Melanoma

- IDEAYA Biosciences announced a partnership with **CRISPR Therapeutics (CRSP)** for the ex-U.S. commercialization of **Darovasertib**, providing capital and enabling focus on the U.S. launch.  **[1676725_tx_379121_0]** **[1676725_tx_379121_1]** **[1676725_tx_379121_8]** 
- The company is preparing for its 10-year anniversary R&D day on **September 8**, where it will provide **three clinical data updates**, including new vision loss data for Darovasertib in the neoadjuvant setting.  **[1676725_tx_379121_0]** **[1676725_tx_379121_5]** **[1676725_tx_379121_6]** 
- IDEAYA will present data for its **DLL3 ADC** program from over **70 patients** at the World Conference on Lung Cancer this weekend, with a target confirmed response rate of **60%** across all lines and a PFS of **six months plus**.  **[1676725_tx_379121_1]** **[1676725_tx_379121_2]** **[1676725_tx_379121_3]** 
- The timeline for the pivotal PFS interim data readout for **Darovasertib** in the metastatic setting has been adjusted to **year-end 2025 or Q1 2026** due to event tracking.  **[1676725_tx_379121_6]** **[1676725_tx_379121_7]** 
- IDEAYA has a **long cash runway into 2030** and plans to have **nine programs in the clinic by year-end**, with Darovasertib, MAT2A, and DLL3 as top priorities.  **[1676725_tx_379121_0]** **[1676725_tx_379121_8]** **[1676725_tx_379121_9]**

IDEAYA Biosciences (IDYA)