Luvometinib Shows Durable Response and Favorable Safety in Pediatric Low-Grade Glioma
According to updated results from a phase 2 study, luvometinib (FCN-159) demonstrated encouraging efficacy with manageable safety among pediatric patients with recurrent or progressive low-grade glioma harboring BRAF or NF1 alterations.
These findings were presented by Wenbin Li, MD, PhD, Beijing Tiantan Hospital, Beijing, China, at the 2025 European Society for Medical Oncology (ESMO) Congress in Berlin, Germany.
In this study, 38 patients were enrolled to receive 5 mg/m2 of continuous once daily luvometinib, adjusted by body surface area. The primary end point was objective response rate (ORR). Key secondary end points included duration of response, progression-free survival (PFS), overall survival (OS), time to response, and safety.
At a median follow-up of 19.8 months, the confirmed ORR was 54.1%. Median duration of response, PFS, and OS were not yet reached. Median time to response was 3.6 months. The confirmed ORR was 82.7% in patients with BRAF V600E mutations, 43.5% in those with KIAA1549–BRAF fusions, and 66.7% in patients with NF1 mutations.
Treatment-related adverse events occurred in 92.1% of patients, the majority of which were grade 1 or 2. Grade 3 treatment-related adverse events occurred in 6 patients and no grade ≥4 adverse events were reported. One serious liver function-related adverse event was reported. Treatment-related adverse events led to 18 dose interruptions. No treatment-related dose reductions, treatment discontinuations, or deaths were reported.
“The updated data showed that FCN-159 exhibited promising efficacy for pLGG with a manageable safety profile and no new safety signal observed,” concluded Dr Li. “A phase 3 randomized controlled trial to evaluate FCN-159 in pLGG is recruiting.”
Source:
Li W, Kang Z, Mao Y, et al. Update on the phase II study: to explore the efficacy and safety of luvometinib (FCN-159) in recurrent or progressive pediatric low-grade glioma with MAPK pathway-activated. Presented at the 2025 ESMO Congress. October 17-21, 2025; Berlin, Germany. Abstract 661MO
