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Updated results from the four-year follow-up analysis of the Phase 2 FIREFLY-1 study provide additional information on the duration of response to OJEMDA® (tovorafenib) in patients with relapsed or refractory BRAF-altered pediatric low-grade glioma
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Breadth of clinical and real-world data expands understanding of VORANIGO® (vorasidenib) in IDH-mutant glioma, including long-term outcomes and experiences across patient populations
BOSTON, Nov. 6, 2026 /PRNewswire/ -- Servier today announced that it will present nine abstracts, including five oral presentations, at the 31st Society for Neuro-Oncology (SNO) Annual Meeting, November 12-15 in Philadelphia. The data span Servier's growing glioma portfolio and include clinical and real-world data for VORANIGO® (vorasidenib) in IDH-mutant glioma, as well as recently released four-year data from the Phase 2 FIREFLY-1 study of OJEMDA® (tovorafenib) in relapsed or refractory BRAF-altered pediatric low-grade glioma (pLGG).
"By expanding the scope of clinical and real-world evidence supporting the safety and efficacy of VORANIGO and OJEMDA, we are deepening our understanding of these complex diseases and generating insights that will help us deliver meaningful treatment advances for people living with glioma," said Islam Hassan, M.D., MSc., Global Head of Development, Neuro-Oncology at Servier. "Our robust body of data at SNO underscores Servier's leadership in glioma and our commitment to advancing targeted therapies for adults and children living with significant unmet needs."
Evaluating long-term outcomes in pLGG
An oral presentation will highlight OJEMDA data in pLGG:
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Updated results from the four-year follow-up analysis of the Phase 2 FIREFLY-1 study will be presented, including data on post-treatment observation and retreatment with OJEMDA following disease progression in patients with relapsed or refractory BRAF-altered pLGG.
Building on the clinical evidence in IDH-mutant glioma
Two oral presentations will feature analyses from the Phase 3 INDIGO trial:
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Extended follow-up (median overall duration of 41.6 months) data from patients with Grade 2 IDH-mutant glioma randomized to receive VORANIGO, including subgroup analyses of histological subtype, will be presented. The results demonstrate sustained, long-term clinical benefits of VORANIGO in Grade 2 IDH-mutant glioma regardless of prognostic factors.
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A separate analysis suggests long-term treatment with VORANIGO generally led to a sustained decrease in seizure activity and delayed worsening of quality of life in patients with IDH-mutant glioma.
Exploring potential beyond the INDIGO population
Two oral presentations will highlight retrospective observational analyses of real-world utilization of VORANIGO in Grade 2 and Grade 3 IDH-mutant glioma:
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Analyses of time to next intervention (TTNI) among 499 patients with Grade 2 IDH-mutant glioma demonstrated short-term real-world effectiveness of VORANIGO. The highest rate was observed among frontline VORANIGO users.
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An analysis of a cohort of 80 Grade 3 mIDH glioma patients showed emerging evidence of the effectiveness of VORANIGO in these patients.
These data collectively reflect Servier's continued investment in advancing glioma research.
About Servier in Oncology
Servier is a global leader in oncology, governed by a non-profit foundation. Servier approaches innovation with a long-term vision, free of influence from fiduciary responsibilities.
Servier invests close to 20% of revenue from brand-name medicines in R&D each year. Servier aspires to advance more targeted therapies by identifying mutations and understanding how these mutations impact cancer and its progression. Servier believes we can serve more people by helping the right patients find the right treatment, at the right time.
Servier takes a One Innovation Engine approach to R&D and is actively seeking alliances, partnerships and acquisitions at various stages of the portfolio.
For more information about working with Servier to bring the promise of tomorrow to the patients it serves, visit Servier.com and Servier.us.
About Glioma1
Gliomas are tumors that arise from glial or precursor cells within the central nervous system (CNS). The 2021 World Health Organization (WHO) classification recognizes four general groups of gliomas, one of which is adult-type diffuse gliomas. These diffuse gliomas are the most common primary malignant brain tumors in adults. The pathogenesis and prognosis of these tumors are tightly linked to mutations (or lack thereof) in the metabolic enzyme isocitrate dehydrogenase (IDH), and molecular testing is required for proper diagnosis. As of 2021, adult-type diffuse gliomas are sub-divided into only three categories:
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Astrocytoma, IDH-mutant (CNS WHO grades 2-4)
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Oligodendroglioma, IDH-mutant and1p/19q-codeleted (CNS WHO grades 2-3)
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Glioblastoma, IDH-wildtype (CNS WHO grade 4)
About Pediatric Low-Grade Glioma
Pediatric low-grade gliomas (pLGG) are the most common brain tumor with an estimated US incidence of 1,100 and Europe incidence of 700 children per year who are eligible for front-line systemic therapy.2, 3 BRAF is the gene most commonly altered in pLGG, which includes two primary types of BRAF alterations – a BRAF gene fusion and BRAF point mutation. These BRAF alterations account for >50% of pLGG cases worldwide and prior to the introduction of OJEMDA, there were no approved treatments for people with pLGG driven by BRAF fusions.2, 4
Pediatric low-grade gliomas can be chronic and relentless, with patients suffering profound side effects from both the tumor and the treatment, which may include chemotherapy and radiation. These side effects can impact their life over the long term, and may include motor deficiencies, vision loss, hormone deficiency and alterations in growth and development. Most children with pLGG will survive their cancer, but for the majority of those in whom a complete surgical resection is not possible, these tumors tend to recur frequently throughout childhood, necessitating multiple treatments. The cumulative toxicity of numerous therapies, along with the damage caused by multiple episodes of tumor progression, take a significant toll on the children and their families.
References
1. Louis DN, Perry A, Wesseling P, Brat DJ, Cree IA, Figarella-Branger D, Hawkins C, Ng HK, Pfister SM, Reifenberger G, Soffietti R, von Deimling A, Ellison DW. The 2021 WHO Classification of Tumors of the Central Nervous System: a summary. Neuro Oncol. 2021 Aug 2;23(8):1231-1251. doi: 10.1093/neuonc/noab106. PMID: 34185076; PMCID: PMC8328013.
2. Ryall S, et al. Acta Neuropathol Commun. 2020;8(1):30.
3. Estimates of annual incidence and prevalence for addressable patient population in E.U. 4 + U.K. are based on Ipsen calculations from publicly available data (Eurostat, <25yo population; Global Burden of Disease 2019; Desandes et al. Incidence and survival of children with central nervous system primitive tumors in the French National Registry of Childhood Solid Tumors. Neuro Oncol. 2014 Jul;16(7):975-83. doi: 10.1093/neuonc/not309; Qaddoumi et al. Outcome and prognostic features in pediatric gliomas: a review of 6212 cases from the Surveillance, Epidemiology, and End Results database. Cancer. 2009 Dec 15;115(24):5761-70. doi: 10.1002/cncr.24663)
4. Traunwieser T, et al. Neurooncol Adv. 2020;2(1):vdaa094.