BlossomHill reports 45% ORR, 88% DCR for BH-30643 in C797S-positive NSCLC; Phase 2 planned

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BlossomHill Therapeutics reported interim Phase 1/2 SOLARA trial results for BH-30643 in EGFR C797S-positive NSCLC, showing a 45% objective response rate and 88% disease control rate. The drug demonstrated durability with 63% of patients remaining on treatment at median 6.9 months follow-up and a favorable safety profile. Following FDA Fast Track designation, the company plans to initiate a global Phase 2 study in Q1 2027.

BlossomHill reported a 45% objective response rate and 88% disease control rate for BH-30643 in EGFR C797S-positive NSCLC.

Key Highlights:

  • Phase 1/2 SOLARA update shows 45% ORR (18/40) and 88% DCR (35/40) in C797S-positive patients.
  • 63% (25/40) of patients remained on treatment at median 6.9 months follow-up, suggesting durability.
  • Favorable safety: among 174 patients at expansion doses, treatment-related dose reductions 9% and discontinuations 3%.
  • Activity observed in a heavily pretreated, heterogeneous cohort: 98% prior osimertinib; 35% had concurrent T790M.
  • Company received FDA Fast Track for BH-30643 and plans a global Phase 2 in C797S-positive NSCLC in Q1 2027.

Original SEC Filing: BlossomHill Therapeutics, Inc. [ BLSM ] - 8-K - Sep. 15, 2026

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