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Comprehensive first-in-human phase I/II study of FHND-9041 in patients with EGFR-mutated advanced non-small cell lung
Liang Zeng1, Fan Tong2, Xingxiang Xu3
1Department of Medical Oncology, Lung Cancer and Gastrointestinal Unit, Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha 410013, China.
Introduction:
FHND-9041 is a novel third-generation EGFR tyrosine kinase inhibitor (EGFR-TKI). This first-in-human study is a single-arm, multi-center, open-label, non-randomized phase Ⅰ/II trial that aims to evaluate the tolerability, safety, pharmacokinetics, and anti-tumor activity of FHND-9041 in patients with EGFR-mutated non-small cell lung cancer (NSCLC).
Methods:
The phase I study enrolled 87 patients with previously-treated EGFR T790M-positive NSCLC. The dose escalation study was conducted at doses of 40, 80, 120, and 180 mg/day, with an expansion of 36 and 39 patients in the 80 mg and 120 mg dose groups, respectively, to evaluate safety and pharmacokinetics. With 80 mg QD as the recommended phase II dose, the phase II study assessed the efficacy and safety of FHND-9041 as first-line treatment in 37 treatment-naive patients.
Results:
No dose-limiting toxicity was observed, and the maximum tolerated dose was not identified within the 40 - 180 mg dose range. Pharmacokinetic data indicated dose-proportional exposure up to 120 mg, with a plateau at 120 mg. The phase II study revealed an objective response rate of 62.2 % (23/37 evaluable patients) with a median progression-free survival of 15.5 months (95 % CI, 12.9 - 18.1). The most common adverse events were decreased white blood cell count (22.6 %) and diarrhea (21.8 %). Treatment-related grade 3/4 adverse events included decreased white blood cell count (11.3 %) and liver impairment (4.8 %).
Conclusions:
FHND-9041 exhibits favorable safety and efficacy profile, supporting its further clinical development for EGFR-mutated advanced NSCLC.
Insights
FHND-9041, a new EGFR inhibitor, shows promising efficacy and safety in advanced non-small cell lung cancer (NSCLC) patients. This study supports its further development for EGFR-mutated NSCLC.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- FHND-9041 is a novel third-generation EGFR tyrosine kinase inhibitor (EGFR-TKI).
- This study evaluates FHND-9041 in patients with EGFR-mutated non-small cell lung cancer (NSCLC).
Purpose of the Study:
- To assess the tolerability, safety, pharmacokinetics, and anti-tumor activity of FHND-9041.
- To determine the recommended Phase II dose for FHND-9041.
Main Methods:
- A single-arm, multi-center, open-label, non-randomized Phase I/II trial.
- Phase I involved 87 patients with previously-treated EGFR T790M-positive NSCLC across various dose levels.
- Phase II assessed first-line treatment in 37 treatment-naive patients at the recommended 80 mg QD dose.
Main Results:
- No dose-limiting toxicity was observed; maximum tolerated dose was not identified.
- Pharmacokinetics showed dose-proportional exposure up to 120 mg.
- Phase II demonstrated an objective response rate of 62.2% and median progression-free survival of 15.5 months.
Conclusions:
- FHND-9041 exhibits a favorable safety and efficacy profile.
- The drug supports further clinical development for EGFR-mutated advanced NSCLC.
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