On September 1, 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 that updated data from the ongoing Phase 1/2 SOLARA trial describing anti-tumor activity of BH-30643 in patients with secondary epidermal growth factor receptor (EGFR) resistance mutations such as EGFR C797S will be shared as a mini-oral presentation on September 15, 2026 at the 2026 World Conference on Lung Cancer in Seoul, South Korea.
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"C797S is a widely recognized mechanism of resistance in EGFR-mutant lung cancer after progression on a third-generation EGFR inhibitor, such as osimertinib, yet there are currently no approved oral targeted therapies for these patients," said Geoff Oxnard, M.D., Chief Medical Officer of BlossomHill Therapeutics. "The anti-tumor activity observed with BH-30643 to date, including across a range of C797S co-mutations and prior treatment histories, is encouraging and supports its potential to address this significant unmet need. We look forward to presenting updated data at WCLC, including longer follow-up that will further inform the emerging clinical profile of BH-30643."
Presentation details:
Title: Anti-Tumor Activity of BH-30643, a Novel Macrocyclic EGFR TKI, in Patients With Secondary EGFR Resistance Mutations
Presenter: Dr. Hidehito Horinouchi, National Cancer Center Hospital, Tokyo, Japan
Date and time: Tuesday, September 15, 11:00 AM KST / Monday, September 14, 10:00 PM EDT
Session: MO12. Closing The Gaps In Driver Altered NSCLC: Moving Beyond Current Boundaries
Location: Room 202, ASEM Ballroom, 2F
The presentation will be available on the company’s Posters & Presentations page following the session: View Source
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 activating 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 1/2, first-in-human clinical trial spanning more than 40 sites in 10 countries. Ongoing dose expansion cohorts are enrolling in both TKI-pretreated and TKI-naive settings, including a C797S resistance cohort. For additional information on SOLARA, including a list of study sites and how to enroll, please visit clinicaltrials.gov (NCT06706076).
About the SOLARA Trial
The Phase 1/2 SOLARA clinical trial (NCT06706076) is a global, open label, multicenter study assessing the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of BH-30643 in patients with epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC). Phase 1 will determine the recommended Phase 2 dose (RP2D) of BH-30643 as a monotherapy and in combination with chemotherapy. Phase 2 is designed to evaluate the antitumor efficacy and safety in specified cohorts determined by mutation subtypes and/or treatment history at the RP2D, as well as the population pharmacokinetics.
(Press release, BlossomHill Therapeutics, SEP 1, 2026, View Source [SID1234670520])