First-line furmonertinib can prolong progression-free survival (PFS), when compared with gefitinib, in patients with EGFR-mutated, advanced non-small cell lung cancer (NSCLC), according to results from the phase 3 FURLONG trial. 

“These results suggest that furmonertinib is a potential new option as first-line treatment in EGFR-mutated NSCLC patients,” said Yuan-Kai Shi, MD, of the Chinese Academy of Medical Sciences & Peking Union Medical College in Beijing.

Dr Shi presented the results from FURLONG at the 2022 European Lung Cancer Congress (ELCC). 


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The phase 3 trial (ClinicalTrials.gov Identifier: NCT03787992) was conducted in 55 hospitals across China. The trial enrolled 358 patients with treatment-naïve, EGFR-mutated (exon 19 deletion or L858R mutation), locally advanced or metastatic NSCLC.

The patients were randomly assigned 1:1 to receive furmonertinib at 80 mg per day (n=178) or gefitinib at 250 mg per day (n=180) as first-line therapy. 

There were no significant differences in the objective response rate (P =.21), disease control rate (P =.36), or depth of response (P =.09) between the treatment arms. 

However, the median duration of response was significantly longer with furmonertinib than with gefitinib — 19.7 months and 10.5 months, respectively (hazard ratio [HR], 0.39; 95% CI, 0.29-0.52; P <.0001).  

Likewise, the median PFS was significantly longer with furmonertinib than with gefitinib — 20.8 months and 11.1 months, respectively (HR, 0.44; 95% CI, 0.34-0.58; P <.0001). The PFS benefit was consistent across all subgroups, including patients with central nervous system metastases (HR, 0.50; 95% CI, 0.32-0.80; P =.0028). 

The overall survival data were not mature at the time of analysis. The median overall survival was not reached in either arm (HR, 0.94; 95% CI, 0.65-1.36; P =.7446).

Despite a longer duration of exposure, furmonertinib had an overall favorable safety profile compared with gefitinib. The median duration of exposure was 18.3 months in the furmonertinib arm and 11.2 months in the gefitinib arm. 

Grade 3 or higher treatment-related adverse events (TRAEs) occurred in 11% of patients treated with furmonertinib and 18% of those who received gefitinib. The most common TRAEs with furmonertinib were diarrhea, rash, and liver abnormalities. All of these events were more frequent in the gefitinib arm.

Disclosures: This research was supported by Shanghai Allist Pharmaceutical Technology and the China National Major Project for New Drug Innovation. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

Reference

Shi Y, Chen G, Wang X, et al. Furmonertinib versus gefitinib in treatment-naïve EGFR mutated non-small cell lung cancer: A randomized, double-blind, multi-center, phase III study (FURLONG). Presented at ELCC 2022; March 30 – April 2, 2022. Abstract 10.