newsfilter
← Latest News
GlobeNewswire·

BlossomHill Therapeutics Announces Outcome from the End-of-Phase 1 Meeting with the FDA and Pivotal Phase 2 Trial Design for OMNI-EGFR™ Inhibitor, BH-30643, in EGFR C797S-Positive NSCLC

BLSM
  • BlossomHill Therapeutics aligned with the FDA on a recommended Phase 2 dose of 50 mg twice daily for its investigational drug BH-30643.
  • The company will advance BH-30643 into SOLARA-2, a registrational intent Phase 2 trial for patients with EGFR C797S-positive NSCLC.
  • The first patient in the SOLARA-2 trial is anticipated to be dosed in the first quarter of 2027.
  • SOLARA-2 is a global, open-label, single-arm study designed to enroll approximately 150 patients, divided into two sub-cohorts of 75 chemotherapy-naive patients and 75 chemotherapy-pretreated patients.
  • All patients in SOLARA-2 will receive BH-30643 at the 50 mg twice daily dose following treatment with a third-generation EGFR TKI.
  • The primary endpoint for SOLARA-2 is objective response rate (ORR) assessed by blinded independent central review, with additional endpoints including duration of response, progression-free survival, overall survival, intracranial ORR, and safety.
  • Preliminary data from the SOLARA Phase 1 trial were presented in 2026 at ASCO and WCLC, with further updates expected in 2027.
  • BH-30643 is an OMNI-EGFR inhibitor that has received FDA Fast Track designation for the treatment of EGFR C797S-positive NSCLC.
  • The trial aims to generate data to support an accelerated approval application for a population with currently no approved oral targeted therapies.