BlossomHill Presents Phase 1/2 Data for BH-30643 in NSCLC

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BlossomHill Therapeutics Presents Updated Phase 1/2 Data for BH-30643 in EGFR-Mutant NSCLC

SAN DIEGO, September 15, 2026 -- BlossomHill Therapeutics, Inc. (Nasdaq: BLSM), a clinical-stage biopharmaceutical company, announced updated clinical data from the ongoing Phase 1/2 SOLARA trial of BH-30643 in non-small cell lung cancer (NSCLC) patients with secondary epidermal growth factor receptor (EGFR) resistance mutations, such as EGFR C797S. The data were presented at the International Association for the Study of Lung Cancer (IASLC) 2026 World Conference on Lung Cancer in Seoul, South Korea.

BH-30643 is an investigational, orally bioavailable, non-covalent, macrocyclic, brain active, mutant-selective OMNI-EGFR inhibitor. In patients with EGFR C797S-positive resistance to prior EGFR inhibitors, with or without concurrent T790M, the treatment demonstrated significant anti-tumor activity and a favorable safety profile.

Key Highlights

  • In 40 patients with EGFR C797S-positive resistance, BH-30643 demonstrated an objective response rate of 45% and a disease control rate of 88%.
  • At the time of efficacy follow-up, 63% of patients remained on treatment with a median follow-up of 6.9 months.
  • Patients had received a median of two prior lines of therapy, including prior osimertinib, chemotherapy, antibody-drug conjugates, and a history of brain metastases.
  • Treatment-related dose reductions and discontinuations were low at 9% and 3%, respectively, among patients treated at expansion doses.

About BlossomHill Therapeutics, Inc.

We are a clinical-stage biopharmaceutical company applying our intentional, chemistry-based approach to develop innovative small molecule medicines that address significant unmet medical needs in cancer treatment. With each of our programs, we combine a deep understanding of disease and protein dynamics with our structure-based rational drug design expertise to identify the specific structural liabilities that limit existing therapies or approaches, and then design novel chemical scaffolds to directly address these limitations. Our scientific founder and the team we have assembled have a proven track record of developing innovative small molecule medicines that overcome the limitations of existing therapies, including multiple approved therapies that have delivered transformational patient outcomes.

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