Dr Le on the Efficacy of Firmonertinib for the Treatment of EGFR PACC–Mutated NSCLC

"[These results are] quite impressive, even for [an] EGFR TKI. We’re very encouraged have these data to help [patients with EGFR PACC–mutated NSCLC].”

Xiuning Le, MD, PhD, an associate professor in the Department of Thoracic/Head and Neck Medical Oncology in the Division of Internal Medicine at The University of Texas MD Anderson Cancer Center, discussed efficacy data with the central nervous system (CNS)–penetrant EGFR inhibitor firmonertinib (Ivesa; formerly furmonertinib) for the treatment of patients with EGFR PACC–mutated non–small cell lung cancer (NSCLC).

During the International Association for the Study of Lung Cancer 2025 World Conference on Lung Cancer, investigators presented updated data from the phase 1b FURTHER trial (FURMO-002; NCT05364073), which evaluated firmonertinib in patients with EGFR PACC–mutated NSCLC. At a median follow-up of 16.5 months (95% CI, 14.6-16.6), patients treated in the first-line PACC cohort at a dose of 240 mg once daily (n = 22) experienced a best objective response rate (ORR) of 81.8% (95% CI, 59.7%-94.8%) and a confirmed ORR (cORR) of 68.2% (95% CI, 45.1%-86.1%), Le said. Additionally, the median duration of response (DOR) was 14.6 months, the disease control rate (DCR) was 100% (95% CI, 84.6%-100%), and the median progression-free survival (PFS) was 16.0 months (95% CI, 11.0-not reached [NR]), she noted.

For patients who received firmonertinib at a daily dose of 160 mg (n = 23), the best ORR was 52.2% (95% CI, 30.6%-73.2%), and the cORR was 43.5% (95% CI, 23.2%-65.5%), Le added. The CR, PR, SD, and PD rates in this cohort were 4.3%, 39.1%, 47.8%, and 8.7%, respectively. The DCR was 91.3% (95% CI, 72.0%-98.9%), and the median PFS was 11.1 months (95% CI, 6.6-NR). The median DOR had not yet been reached at the time of data cutoff, she said.

Le emphasized that firmonertinib produced meaningful and durable antitumor activity across both dose levels, though higher response rates and more prolonged disease control were observed at the 240-mg dose. She concluded that the CNS-penetrant profile of firmonertinib supports its use in patients with brain metastases.