Servier Presents Updated Four-Year Results from Phase 2 FIREFLY-1 Study of OJEMDA® (tovorafenib) in Pediatric Low-Grade Glioma (pLGG) at SNO 2026

详细摘要

Updated longer-term analysis, including up to four years of follow-up data in patients with relapsed or refractory BRAF-altered pediatric low-grade glioma treated with…

BOSTON, Nov. 14, 2026 /PRNewswire/ -- Servier today announced updated four-year results from the Phase 2 FIREFLY-1 study of OJEMDA® (tovorafenib) in patients aged six months to 25 years with relapsed or refractory BRAF-altered pediatric low-grade glioma (pLGG). The data are being presented as an oral presentation at the 31st Society for Neuro-Oncology (SNO) Annual Meeting on November 14 at 3:45 p.m. EST in Philadelphia.

The four-year FIREFLY-1 analysis includes exploratory outcomes across the treatment and post-treatment observation periods, with a median study duration of 52.5 months in the registrational arm as of the June 5, 2026, data cutoff. Patients received OJEMDA orally once weekly in 28-day cycles for 26 cycles, after which they could continue treatment or enter the optional post-treatment observation period. The analysis assessed exploratory endpoints of time to next treatment and treatment-free interval to further characterize outcomes following treatment discontinuation.

"With four years of follow-up from FIREFLY-1, we are building a more complete picture of OJEMDA's long-term outcomes, which will help physicians and families make critical treatment decisions," said Elly Barry, MD, Vice President of Clinical Development, Servier Pharmaceuticals. "We are proud to share these results, which, combined with the consistent safety profile, reinforce OJEMDA's role as a meaningful treatment option. We remain committed to evaluating the effects of OJEMDA over time and continuing to support children, adolescents and young adults with pLGG."

Updated 4-year results from the phase 2 FIREFLY-1 study: Deep responses and prolonged time off therapy with tovorafenib in relapsed/refractory pediatric low-grade glioma – Saturday, November 14, 3:45 – 3:52 p.m. EST

Key findings from the exploratory analysis to be presented by Daniel Landi, MD, Duke University and Duke Cancer Institute, an investigator on the FIREFLY-1 trial, include:

"For children and families living with…

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