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

“We are pleased with the outcome of our End-of-Phase 1 meeting with FDA and are confident in our development strategy for BH-30643 in EGFR C797S-positive NSCLC. Our planned Phase 2 trial, designed with registrational intent, builds on the encouraging clinical activity observed in SOLARA, where BH-30643 has demonstrated promising anti-tumor activity in NSCLC patients with EGFR C797S-positive resistance, including those with and without concurrent T790M mutation and brain metastasis, and those who have received multiple prior therapies,” said J. Jean Cui, Ph.D., Founder and Chief Executive Officer of BlossomHill Therapeutics. “The selection of 50 mg twice daily as our recommended Phase 2 dose, together with the clinical experience we have observed to date, provides strong support for advancing the program. By evaluating BH-30643 in both chemotherapy-naive and chemotherapy-pretreated patients, we aim to further characterize its potential to address this important resistance mechanism and generate the evidence needed to support a potential accelerated approval.”