Shanghai-based biotech Allist Pharmaceuticals Co., Ltd and its US partner ArriVent Biopharma Inc. have jointly released interim data from a Phase Ib trial at the 2023 World Conference on Lung Cancer (WCLC) meeting. The trial assessed the efficacy of furmonertinib as a treatment for non-small cell lung cancer (NSCLC), specifically in patients with EGFR exon 20 insertion mutations.
FAVOUR Study Design and Interim Results
The China-based FAVOUR study (NCT04858958) is a randomized, open-label, multi-center trial focused on patients with locally advanced or metastatic NSCLC. The interim data demonstrated promising efficacy for furmonertinib, an irreversible, selective, third-generation EGFR tyrosine-kinase inhibitor discovered in-house by Allist and co-developed with ArriVent outside of Greater China under a 2021 deal. The overall response rate (ORR) in treatment-naïve patients was 78.6%, with a median duration of response (DOR) of 15.2 months. For previously treated patients, the 240 mg and 160 mg doses showed confirmed ORRs of 46.2% and 38.5%, respectively.
Initiation of Global Phase III Study
Encouraged by the positive interim data, Allist and ArriVent have initiated a global Phase III study in first-line patients with locally advanced or metastatic NSCLC with EGFR Exon20ins mutations (FURVENT/FURMO-004; NCT05607550). This study aims to further evaluate the efficacy and safety of furmonertinib in a broader patient population and could potentially lead to a new treatment option for NSCLC patients with EGFR Exon20ins mutations.-Fineline Info & Tech