secwatch.observer — SEC 8-K summary
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Issuer:     BlossomHill Therapeutics, Inc. (BLSM)
CIK:        0001839970
Form:       8-K
Filed at:   2026-09-15T11:30:06+00:00
Accession:  0001193125-26-391328
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

BlossomHill reports 45% ORR for BH-30643 in EGFR C797S-positive NSCLC from SOLARA trial
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- ORR 45% (18/40) and DCR 88% (35/40) in EGFR C797S-positive NSCLC patients with prior EGFR inhibitor resistance, ± T790M.
- 63% (25/40) remained on treatment at median follow-up 6.9 months; 98% had prior osimertinib, 35% concurrent T790M.
- Safety (n=174, 40/50/60 mg BID): treatment-related dose reductions 9%, discontinuations 3%; common AE bilirubin elevation.
- Plans global Phase 2 targeting EGFR C797S-positive NSCLC in Q1 2027; FDA Fast Track designation previously granted.
- Activity seen across pretreated population: median 2 prior lines; 53% prior chemo/ADC; 53% history of brain metastases.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1839970/000119312526391328/0001193125-26-391328-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1839970/000119312526391328/d168153d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-391328

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