BlossomHill plans pivotal Phase 2 trial of BH-30643 in lung cancer for Q1 2027
BLSM•BlossomHill Therapeutics plans to start the SOLARA-2 Phase 2 trial of BH-30643 in EGFR C797S-positive lung cancer in Q1 2027, with an FDA-aligned dose of 50 mg twice daily. The trial aims to enroll about 150 patients previously treated with third-generation EGFR inhibitors.
1. Trial plans
BlossomHill Therapeutics plans to begin the pivotal Phase 2 SOLARA-2 trial in the first quarter of 2027. The study will test BH-30643 in approximately 150 patients with EGFR C797S-positive lung cancer who were previously treated with third-generation EGFR inhibitors, split equally between chemotherapy-naive and chemotherapy-pretreated groups. The FDA aligned on a 50 mg twice-daily dose, which could support an accelerated approval application.
2. Results and updates
Preliminary SOLARA results presented at ASCO and WCLC in 2026 showed antitumor activity, including in patients with brain metastases. The company plans to present further results at medical meetings in 2027, including response durability updates and initial data on chemotherapy combinations.
