KEY TAKEAWAYS
- FURLONG (NCT03787992), a phase 3 study, assessed the efficacy of furmonertinib and gefitinib in untreated patients with EGFR-sensitizing mutation.
- The study aimed to compare the CNS efficacy of furmonertinib and gefitinib in EGFR-sensitizing mutation-positive NSCLC.
- The researchers used a randomized, double-blind trial in which 358 patients (1:1 ratio) were made to take furmonertinib or gefitinib.
- The study improved progression-free survival, objective response rate, and depth of response with furmonertinib.
The pan-EGFR tyrosine kinase inhibitor furmonertinib (AST2818) has antitumor activity in the central nervous system (CNS). Researchers present data from the FURLONG research comparing the CNS efficacy of furmonertinib and gefitinib in previously untreated patients with EGFR-sensitizing mutation-positive NSCLC.
The FURLONG study involved 55 hospitals across the People’s Republic of China and was a randomized, double-blind, phase 3 trial. To a ratio of 1:1, patients were randomly assigned to receive either 80 mg of furmonertinib once daily or 250 mg of gefitinib once daily. All of the patients had a brain scan during the preliminary evaluation. This predetermined CNS subgroup study included only patients with stable CNS metastases at baseline and no symptoms.
The FURLONG research enrolled a total of 358 participants. The median CNS progression-free survival in the furmonertinib group was 20.8 months (95% CI: 15.2-25.3), and in the gefitinib group, it was 9.8 months (95% CI: 7.2-18.0) (hazard ratio = 0.40 [95% CI: 0.23-0.71], p = 0.0011). The CNS objective response rate was 65% (95% CI: 48-80) with gefitinib and 91% (95% CI: 72-99) with furmonertinib (OR = 6.82 [95% CI: 1.23-37.67], p = 0.0277) in the 60 patients (17%) with measurable CNS lesions. CNS depth of response was significantly higher in the furmonertinib group (62%, 95% CI: 51-72) than in the gefitinib group (39%, 95% CI: 30-47), with a least-squares mean difference of 23% (95% CI: 10-37, p = 0.0011).
Patients with EGFR-mutated NSCLC and CNS metastases had better progression-free survival, objective response rate, and depth of response with furmonertinib as first-line therapy compared to gefitinib.
Source: https://pubmed.ncbi.nlm.nih.gov/35932953/
Clinical trial: https://clinicaltrials.gov/ct2/show/NCT03787992
Shi, Y., Chen, G., Wang, X., Liu, Y., Wu, L., Hao, Y., Liu, C., Zhu, S., Zhang, X., Li, Y., Liu, J., Cao, L., Cheng, Y., Zhao, H., Zhang, S., Zang, A., Cui, J., Feng, J., Yang, N., Liu, F., … Gu, C. (2022). Central Nervous System Efficacy of Furmonertinib (AST2818) Versus Gefitinib as First-Line Treatment for EGFR-Mutated NSCLC: Results From the FURLONG Study. Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, S1556-0864(22)01496-4. Advance online publication. https://doi.org/10.1016/j.jtho.2022.07.1143