other material
confidence high
sentiment positive
materiality 0.80
BlossomHill reports 45% ORR for BH-30643 in EGFR C797S-positive NSCLC from SOLARA trial
BlossomHill Therapeutics, Inc.
- 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.