secwatch.observer — SEC 8-K summary
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Issuer:     IDEAYA Biosciences, Inc. (IDYA)
CIK:        0001676725
Form:       8-K
Filed at:   2024-07-08T23:59:59+00:00
Accession:  0001193125-24-175867
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

IDEAYA reports 39% ORR in IDE397 Phase 2 monotherapy for MTAP-deletion cancers
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- Overall response rate 39% (1 CR, 6 PRs by RECIST 1.1) in 18 evaluable MTAP-deletion urothelial cancer and NSCLC patients.
- Disease control rate 94%; tumor shrinkage observed in 14/18 evaluable patients; 5 of 7 responses still ongoing.
- 81% ctDNA molecular response rate (13/16 reportable patients with ≥50% ctDNA reduction).
- Favorable safety: 5.6% Grade 3+ drug-related AE (1 asthenia); no drug-related discontinuations.
- No FDA-approved therapies for MTAP-deletion solid tumors; IDE397 30 mg QD tablet enables long-term dosing.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1676725/000119312524175867/0001193125-24-175867-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1676725/000119312524175867/d587447d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-175867

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer