BlossomHill Therapeutics to Showcase Promising Phase 1 Results of BH-30643 for Advanced EGFR-Mutant NSCLC at ASCO 2026
BlossomHill Therapeutics to Present Preliminary Results From Phase 1 Dose Escalation/Backfill Cohorts in Phase 1/2 SOLARA Trial of OMNI-EGFR Inhibitor, BH-30643, in Advanced EGFR-mutant NSCLC at the 2026 ASCO Annual Meeting
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BlossomHill Therapeutics will present preliminary results from the Phase 1/2 SOLARA trial of BH-30643, a novel OMNI-EGFR inhibitor, at the 2026 ASCO Annual Meeting. The drug showed promising clinical activity in patients with advanced EGFR-mutant non-small cell lung cancer (NSCLC), particularly those with challenging mutations like C797S/T790M.
- 01The Phase 1 trial involved 82 patients, with a median of 3 prior lines of therapy and 66% having a history of brain metastases.
- 02BH-30643 demonstrated a favorable tolerability profile, with 27% of patients experiencing Grade ≥2 EGFR-wildtype treatment-related adverse events.
- 03Confirmed response rates for patients with C797S mutations were reported at 50% without prior chemotherapy and 39% with prior chemotherapy.
- 04High plasma exposures of BH-30643 exceeded target EC90 levels at candidate doses.
- 05The presentation will occur on June 2, 2026, during a rapid oral session at the ASCO Annual Meeting.
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BlossomHill Therapeutics, based in San Diego, California, is set to present preliminary data from its Phase 1/2 SOLARA clinical trial of BH-30643 at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting on June 2, 2026. BH-30643 is a novel, non-covalent, macrocyclic OMNI-EGFR inhibitor targeting a range of EGFR mutations, including those associated with resistance, such as C797S and T790M. The trial enrolled 82 patients with advanced EGFR-mutant non-small cell lung cancer (NSCLC), many of whom had undergone multiple prior therapies, with 66% having a history of brain metastases. The data indicated promising clinical activity, particularly in patients with difficult-to-treat mutations. Specifically, the overall response rates for patients with C797S mutations were 50% for those without prior chemotherapy and 39% for those who had received chemotherapy. BH-30643 exhibited a favorable safety profile, with 27% of patients experiencing Grade ≥2 treatment-related adverse events. The ongoing Phase 1 dose expansion aims to establish the recommended Phase 2 dose, focusing on patients with C797S-positive resistance mutations. This innovative therapy could potentially fill a significant gap in treatment options for patients with advanced EGFR-mutant NSCLC.
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The promising results of BH-30643 could lead to new treatment options for patients with advanced EGFR-mutant NSCLC, particularly those with limited current therapies.
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