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BlossomHill Therapeutics Presents Updated Data from Ongoing Phase 1/2 SOLARA Trial Demonstrating Encouraging Anti-Tumor Activity of OMNI-EGFR™ Inhibitor BH-30643 in EGFR C797S-Positive NSCLC at IASLC 2026 World Conference on Lung Cancer

BLSM
  • BlossomHill Therapeutics reported updated Phase 1/2 SOLARA trial data for BH-30643 in patients with EGFR C797S-positive NSCLC resistance at the IASLC 2026 World Conference.
  • The drug demonstrated a 45% objective response rate (18 of 40 patients) and an 88% disease control rate in patients with prior EGFR inhibitor resistance, with or without concurrent T790M.
  • 63% of patients remained on treatment as of the August 10, 2026 follow-up, with a median follow-up duration of 6.9 months.
  • BH-30643 showed a favorable safety profile, with only 9% of patients requiring dose reductions and 3% discontinuing treatment due to adverse events.
  • The most common treatment-related adverse event was asymptomatic bilirubin elevation, consistent with UGT1A1 inhibition.
  • The patient population was heavily pretreated, with 98% receiving prior osimertinib, 53% receiving prior chemotherapy or antibody-drug conjugates, and 35% having concurrent T790M mutations.
  • The FDA granted Fast Track designation to BH-30643 for the treatment of advanced or metastatic EGFR C797S-positive NSCLC.
  • BlossomHill Therapeutics plans to initiate a global Phase 2 study for BH-30643 targeting EGFR C797S-positive NSCLC in Q1 2027.
  • BH-30643 is an investigational, non-covalent, macrocyclic, brain-active inhibitor designed to overcome on-target EGFR resistance mechanisms.