BlossomHill Therapeutics Presents Promising Findings in Phase 1/2 SOLARA Trial for BH-30643 in NSCLC Patients

BlossomHill Therapeutics, a clinical-stage biopharmaceutical company, has presented preliminary findings from the dose escalation portion of its ongoing Phase 1/2 SOLARA trial of BH-30643 in patients with locally advanced or metastatic EGFR-mutant non-small cell lung cancer (NSCLC). BH-30643 is a first-in-class, macrocyclic, non-covalent, mutant selective OMNI-EGFR inhibitor designed to target a broad spectrum of EGFR mutations, including those driving resistance to current therapies. The company reported that high plasma exposures were observed in patients, well exceeding target EC90, and highlighting several case examples showing tumor reductions in heavily pretreated EGFR-mutant NSCLC patients.

Key Takeaways:

• The Phase 1/2 SOLARA trial has enrolled 39 patients with previously treated EGFR-mutant NSCLC across dose cohorts ranging from 20 mg to 160 mg total daily dose of BH-30643.
• High plasma exposures were observed in patients, well exceeding target EC90, and comparing favorably with the exposures seen with contemporary EGFR inhibitors.
• Several case examples showed tumor reductions in heavily pretreated EGFR-mutant NSCLC patients, including those with complex and difficult-to-treat mutations such as C797S + exon 19 deletion, C797S + T790M + exon 19 deletion, G724A + exon 19 deletion, T790M + exon 20 insertion, and exon 20 insertion with brain metastases.
• BH-30643 stands out with its fundamentally novel macrocyclic architecture, designed to potently, selectively, and non-covalently target a broad range of EGFR mutations, including those driving resistance to current therapies.
• The poster presentation highlights the potential of BH-30643 to become an important advancement in the treatment of EGFR-mutant NSCLC, overcoming the resistance limitations of contemporary EGFR inhibitors.
• Enrollment of both targeted therapy-naive and pretreated patients is ongoing into expansion cohorts to further characterize the clinical profile of BH-30643.

Statistics:

• 39 patients with previously treated EGFR-mutant NSCLC were enrolled into the Phase 1 dose escalation portion of the SOLARA trial across dose cohorts ranging from 20 mg to 160 mg total daily dose of BH-30643.
• High plasma exposures were observed in patients, with exposures well exceeding target EC90.
• The tumor reduction observed in heavily pretreated EGFR-mutant NSCLC patients demonstrates the potential of BH-30643 to overcome resistance limitations of contemporary EGFR inhibitors.

Sources:

• GlobeNewswire, "BlossomHill Therapeutics Presents Preliminary Findings from the Ongoing Phase 1/2 SOLARA Trial of BH-30643 in Patients with Locally Advanced or Metastatic EGFR-Mutant Non-Small Cell Lung Cancer (NSCLC)", October 24, 2025.
• BlossomHill Therapeutics, "About the Phase 1/2 SOLARA Trial".
• BlossomHill Therapeutics, "About BH-30643".