45% objective response rate and 88% disease control rate observed in patients with EGFR C797S-positive resistance to prior EGFR inhibitors, with or without concurrent T790M, a difficult-to-treat population with no approved targeted therapies
BH-30643 demonstrated a favorable safety profile with low rates of dose reduction or discontinuation due to treatment-related adverse events
Presentation follows receipt of FDA Fast Track designation for BH-30643 for the treatment of advanced or metastatic EGFR C797S-positive NSCLC
SAN DIEGO, Sept. 15, 2026 (GLOBE NEWSWIRE) -- BlossomHill Therapeutics, Inc. (NASDAQ:BLSM), a clinical-stage biopharmaceutical company applying an intentional, chemistry-based approach to design and develop innovative small molecule medicines for the treatment of cancer, today announced updated 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 highlighted in a mini-oral presentation 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, novel, orally bioavailable, non-covalent, macrocyclic, brain active, mutant-selective, OMNI-EGFR™ inhibitor designed to overcome the limitations of currently approved EGFR inhibitors for the treatment of EGFR-mutant NSCLC. In patients with EGFR C797S-positive resistance to prior EGFR inhibitor treatment, with or without concurrent T790M, BH-30643 demonstrated a 45% objective response rate (ORR; 18/40) and an 88% disease control rate (DCR; 35/40). At the time of efficacy follow-up, 63% (25/40) of patients remained on treatment with a median follow-up of 6.9 months. BH-30643 also demonstrated a favorable safety profile with low rates of dose reduction or discontinuation due to treatment-related adverse events.