BlossomHill Therapeutics has dosed the first subject in the expansion cohorts of the SOLARA Phase I/II trial to evaluate BH-30643 in individuals with advanced epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC).
The first-in-human, open label and global trial is intended to assess the tolerability, efficacy and safety of the therapy in NSCLC patients who exhibit EGFR or HER2 mutations.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
BH-30643 is a new macrocyclic, non-covalent inhibitor that targets mutant forms of the EGFR.
It has demonstrated sub-nanomolar potency against both classical and atypical EGFR mutations.
BlossomHill Therapeutics president and CEO Jean Cui said: “The increasing diversity of EGFR mutations has led to a growing number of therapeutic agents targeting various, narrowly defined subsets of EGFR mutation-positive lung cancer.
“When designing BH-30643, we pursued a different and broader ambition – a highly potent drug capable of inhibiting a wide spectrum of EGFR mutations, while sparing inhibition of wildtype EGFR and HER2, expected to provide a significant survival benefit and a better tolerated therapy for more patients.”
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataThe expansion cohorts aim to evaluate BH-30643’s single-agent objective response rate (ORR) in a diverse patient population, including those who have not previously undergone EGFR-targeted therapy.
BlossomHill’s decision to proceed with patient dosing in these cohorts follows successful dose escalation results.
The results indicated a favourable tolerability and pharmacokinetic profiles of BH-30643, alongside preliminary evidence of anti-tumour activity in patients previously treated for EGFR-mutant NSCLC.
BlossomHill Therapeutics chief medical officer Dr Geoff Oxnard said: “Enrolment of the SOLARA expansion cohorts will be a critical step toward achieving that goal, allowing us to characterise drug activity across a diversity of targeted therapy pretreated and targeted therapy naive patient populations.”
