On March 31, 2022 Allist Pharmaceuticals Co., Ltd., reported that the European Lung Cancer Congress (ELCC) published an abstract detailing results from the FURLONG study, a Phase 3 pivotal trial of Ivesa (Furmonertinib) in a first-line setting of patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-small cell lung cancer (NSCLC) (Press release, ArriVent Biopharma, MAR 31, 2022, https://arrivent.com/ivesa-demonstrates-progression-free-survival-of-over-20-months-in-first-line-setting-for-egfr-mutated-advanced-nsclc/ [SID1234611280]). The FURLONG study demonstrated that first-line treatment with Ivesa resulted in a median progression-free survival (PFS) of 20.8 months and reduced the risk of disease progression or death by 56% compared to Gefitinib.
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The FURLONG study was sponsored by Shanghai Allist Pharmaceuticals Co., Ltd. (hereinafter referred to as "Allist", Stock Code: 688578), and led by Professor Yuankai Shi from Cancer Hospital Chinese Academy of Medical Sciences.
Key Results
FURLONG is a national multi-center, randomized, double-blind, placebo-controlled, Phase 3 study designed to assess the efficacy and safety of Ivesa (Furmonertinib) versus Iressa (Gefitinib) in treatment-naïve patients with locally advanced or metastatic EGFRm NSCLC.
The final results show that the median PFS is significantly prolonged with Ivesa compared to Gefitinib group by 9.7 months (PFS, 20.8 months vs 11.1 months, hazard ratio [HR] 0.44 [95% confidence interval 0.34-0.58], p<0.0001), and the risk of disease progression or death was reduced by 56%. Despite the longer exposure, the incidence of grade ≥ 3 adverse reactions of Ivesa group is still lower than that of the Gefitinib group (11% vs 18%).
The release of breakthrough results of FURLONG study further concluded that first-line Ivesa provided a significant improvement versus the comparator first-generation EGFR-TKI in patients with EGFR-mutated advanced NSCLC. Ivesa is the only third-generation EGFR TKI that showed the primary endpoint PFS value beyond 20 months and the risk of disease progression or death reduced by 56% in a pivotal stage study versus a first-generation EGFR-TKI.
The detail of FURLONG study results will be released in the form of Proffered Paper session at ELCC on March 31, 2022.
Comments from Professor Yuankai Shi, Principal Investigator of FURLONG study, from National Cancer Center/Cancer Hospital Chinese Academy of Medical Sciences:
"Lung cancer is one of the malignant tumors with highest incidence rate and mortality rate in China. The EGFR mutation is the most common driven gene mutation in lung cancer. There is still an unmet clinical demand for the first-line treatment of NSCLC patients harboring EGFR sensitive mutations. The results of the FURLONG study are so exciting that Furmonertinib showed median PFS of 20.8 months as the first line treatment with favorable safety profile, providing an additional and better option for the first-line treatment for patients with locally advanced or metastatic NSCLC harboring EGFR sensitive mutations."