---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-251399"
form_type: "8-K"
ticker: "IDYA"
cik: "0001676725"
company_name: "IDEAYA Biosciences, Inc."
filed_at: "2026-06-01T20:05:32+00:00"
generated_at: "2026-06-01T20:14:38.995131+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# IDEAYA's darovasertib combo meets primary endpoint in Phase 2/3 OptimUM-02 trial for metastatic uveal melanoma

## Summary
- Darovasertib + crizotinib achieved median PFS 6.9 months vs 3.1 months for investigator's choice (HR=0.42, p<0.0001) by BICR, reducing risk of progression by 58%.
- Objective response rate 37.1% (combo) vs 5.8% (control) by BICR; disease control rate 73.3% vs 31.1%.
- Grade 3/4 TRAEs 40.6% vs 37.0%; treatment-related discontinuations low (darovasertib 2.5%, crizotinib 10.0% vs ICT 19.0%).
- FDA agreed to review darovasertib NDA under Real-Time Oncology Review; submission expected in H2 2026.
- Overall survival data immature but early trend favoring combo; future analysis will support full approval.

## SEC filing metadata
- accession: 0001193125-26-251399
- form_type: 8-K
- ticker: IDYA
- cik: 0001676725
- company_name: IDEAYA Biosciences, Inc.
- filed_at: 2026-06-01T20:05:32+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1676725/000119312526251399/0001193125-26-251399-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1676725/000119312526251399/d138848d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-251399
- JSON: https://secwatch.observer/filing/0001193125-26-251399.json
- Plain text: https://secwatch.observer/filing/0001193125-26-251399.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.