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On November 1, 2021, Shanghai Allist Pharmaceuticals Co., Ltd. ("Allist", stock code: 688578) announced that the Phase III, national multicenter, randomized, controlled, double-blind clinical study (FURLONG) of Furmonertinib, a self-developed third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR-sensitive mutations, met its primary study endpoint of progression-free survival (PFS). Compared with the control group receiving the first-generation EGFR-TKI Gefitinib (Iressa?), the Furmonertinib treatment group showed statistically and clinically significant PFS benefits. The specific data results of the study will be officially announced at future international academic conferences.
Professor Yuankai Shi FURLONG PI National Cancer /Cancer Hospital Chinese Academy of Medical Sciences express:There are unmet for the first-line treatment of NSCLC patients with EGFR gene-sensitive mutations.The results of the FURLONG study are worth looking forward to.With the release of spacific data in the future,people will have a more detailed understanding of FURLONG .These findings show a good efficacy and safety of Furmonertinib,providing a new first-line treatment option for patents with locally advanced or metastaic NSCLC whose tumours harbour a EGGFR gene-sensitive mutation.
Jinhao Du Allist Chairman express:Furmonertinib is an independent innovative product resulting from 10 years'great efforts of Allist.The positive result of FURLONG marks an important milestone in the history of Allist's innovative drug research and development.With"In China For Global"as its development stategy,Allist is,driven by scientific and institutional innovations both at home and abroad,further advanced and perrioperative patients,including those with EGFR-sensitive,rare,or duug-resistant mutations.
Sandy Mu Allist CEO express:We are proud of the coonvincing clinical research date of Furmonertinib and its excellent performance in the clinical practice. The FURLONG study has achieved exciting reesults and will bring new historic breakthroughs.We will actively communicate the FURLONG research rsults with NMPA,and strive to accelerate the approval of Furmonertinib for the treatment of first-line indication,so as to better benefit patients with EGFR mutant advanced ling cancer.
FURLONG is a phase III, randomized, double-blind, positive-controlled, multi-center clinical study, which aims to compare the efficacy and safety of Furmonertinib mesylate (AST2818) with Gefitinib (Iressa?) in the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer whose tumours harbours EGFR-sensitive mutations.
The study was conducted at 55 sites in China and enrolled 358 patients with EGFR-mutated advanced NSCLC who were randomized to receive Furmonertinib 80 mg/d or Gefitinib 250 mg/d as the first-line treatment until disease progression or withdrawal due to other reasons.
The primary endpoint of the study was progression-free survival (PFS), and the secondary endpoints included objective response rate (ORR), overall survival (OS), and safety.