On Nvoember 9, 2026 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, reported the outcome of its End-of-Phase 1 meeting with the U.S. Food and Drug Administration (FDA) regarding BH-30643 for the treatment of patients with advanced or metastatic epidermal growth factor receptor (EGFR) C797S-positive non-small cell lung cancer (NSCLC). 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.

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BlossomHill plans to advance BH-30643 into SOLARA-2, the Phase 2 portion of the SOLARA trial, following alignment with FDA on a recommended Phase 2 dose of 50 mg twice daily. SOLARA-2 is the global, open-label, single-arm Phase 2 portion of the SOLARA trial, intended to generate data that could potentially support an accelerated approval application in patients with EGFR C797S-positive NSCLC, a population for which there are currently no approved oral targeted therapies. SOLARA-2 is designed to evaluate both chemotherapy-naive and chemotherapy-pretreated patients following treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI). The trial will leverage the current global footprint of the SOLARA trial, with the first patient anticipated to be dosed in the first quarter of 2027. BH-30643 previously received FDA Fast Track designation for EGFR C797S-positive NSCLC.

"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."

Preliminary data from SOLARA were presented in 2026 at both the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and World Conference on Lung Cancer (WCLC). The company expects to share additional updates from SOLARA at medical meetings in 2027, including updates on C797S durability and TKI-naive durability, as well as initial data from the chemotherapy-combination cohort.

SOLARA-2 Trial
SOLARA-2 is the pivotal single-arm Phase 2 portion of the SOLARA trial, designed with registrational intent to evaluate BH-30643 in approximately 150 patients with locally advanced or metastatic EGFR C797S-positive NSCLC who have previously received a third-generation EGFR TKI. The open-label study will include two sub-cohorts of approximately 75 patients each: chemotherapy-naive patients and chemotherapy-pretreated patients. All patients will receive BH-30643 at the recommended Phase 2 dose of 50 mg twice daily. The primary endpoint will be objective response rate (ORR), as assessed by blinded independent central review (BICR), with additional endpoints including duration of response (DOR), progression-free survival (PFS), overall survival (OS), intracranial ORR and safety. For additional information on SOLARA, including a list of study sites and how to enroll, please visit clinicaltrials.gov (NCT06706076).

About BH-30643
BH-30643 is an investigational, novel, orally bioavailable, non-covalent, macrocyclic, brain active, mutant-selective, OMNI-EGFR inhibitor for the treatment of EGFR-mutant NSCLC. BH-30643 was designed to overcome the limitations of currently approved EGFR inhibitors, which were discovered over a decade ago without the current, modern understanding of the structure and protein dynamics of mutant EGFRs. In preclinical studies, BH-30643 demonstrated potent inhibitory activity across diverse EGFR mutation categories — classical mutations, on-target resistance mutations such as C797S with or without T790M, atypical mutations and exon 20 insertions — while maintaining marked selectivity over wild-type EGFR. BH-30643 has received Fast Track designation and is being evaluated in SOLARA, a global Phase 1, first-in-human clinical trial with ongoing dose expansion cohorts enrolling in both TKI-pretreated and TKI-naive settings, including a C797S resistance cohort. SOLARA-2, a global Phase 2 pivotal study in C797S-Positive NSCLC is scheduled to dose the first patient in the first quarter of 2027. For additional information on SOLARA, including a list of study sites and how to enroll, please visit clinicaltrials.gov (NCT06706076).

(Press release, BlossomHill Therapeutics, NOV 9, 2026, View Source [SID1234674521])