Servier Highlights Growing Neuro-Oncology Portfolio with New Data Across Pediatric and Adult Glioma at SNO 2026

• 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
• 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 31^st 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:

• 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:

• 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.
• 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:

• 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. 
• 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. A full list of Servier abstracts and presentation details for SNO 2026 can be found here.

Media Contact 
Darby Malkin: [email protected]

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:

• Astrocytoma, IDH-mutant (CNS WHO grades 2-4)
  
  
• Oligodendroglioma, IDH-mutant and1p/19q-codeleted (CNS WHO grades 2-3)
  
  
• 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.

VORANIGO IMPORTANT SAFETY INFORMATION

What is VORANIGO?

VORANIGO (40 mg tablets) is a prescription medicine used to treat adults and children 12 years of age and older with certain types of brain tumors called astrocytoma or oligodendroglioma with an isocitrate dehydrogenase-1 (IDH1) or isocitrate dehydrogenase-2 (IDH2) mutation, following surgery. Your healthcare provider will perform a test to make sure that VORANIGO is right for you. It is not known if VORANIGO is safe and effective in children under 12 years of age.

What are the possible side effects of VORANIGO?

VORANIGO may cause serious side effects, including:

• Liver problems. Changes in liver function blood tests may happen during treatment with VORANIGO and can be serious. Your healthcare provider will do blood tests to check your liver function before and during treatment with VORANIGO. Tell your healthcare provider right away if you develop any of the following signs and symptoms of liver problems:
  
  
• yellowing of your skin or the white part of your eyes (jaundice)
  
  
• dark tea-colored urine
  
  
• loss of appetite
  
  
• pain on the upper right side of your stomach area
  
  
• feeling very tired or weak

The most common side effects of VORANIGO include:

• increased liver enzyme levels in the blood
  
  
• lack of energy, tiredness
  
  
• headache
  
  
• COVID-19
  
  
• muscle aches or stiffness
  
  
• diarrhea
  
  
• nausea
  
  
• seizure

Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with VORANIGO if you have certain side effects.

VORANIGO may affect fertility in females and males, which may affect the ability to have children. Talk to your healthcare provider if this is a concern for you.
These are not all of the possible side effects of VORANIGO.

Before taking VORANIGO, tell your healthcare provider about all of your medical conditions, including if you:

• have liver problems
  
  
• have kidney problems or are on dialysis
  
  
• smoke tobacco
  
  
• are pregnant or plan to become pregnant. VORANIGO can harm your unborn baby

Females who are able to become pregnant:

• Your healthcare provider will do a pregnancy test before you start treatment with VORANIGO
  
  
• You should use effective nonhormonal birth control during treatment with VORANIGO and for 3 months after the last dose. VORANIGO may affect how hormonal contraceptives (birth control) work and cause them to not work well. Talk to your healthcare provider about birth control methods that may be right for you during treatment with VORANIGO
  
  
• Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with VORANIGO

Males with female partners who are able to become pregnant:

• You should use effective birth control during treatment with VORANIGO and for 3 months after the last dose
  
  
• Tell your healthcare provider right away if your partner becomes pregnant or thinks she may be pregnant during your treatment with VORANIGO

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if VORANIGO passes into breast milk. Do not breastfeed during treatment with VORANIGO and for 2 months after the last dose.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. VORANIGO may affect the way other medicines work, and other medicines may affect how VORANIGO works.

Please click here for full prescribing information.

OJEMDA INDICATION and IMPORTANT SAFETY INFORMATION

WHAT IS OJEMDA^® (tovorafenib)? 

OJEMDA is a prescription medicine used to treat a type of brain tumor (cancer) called pediatric low-grade glioma (pLGG) in people 6 months of age and older whose tumor has come back after previous treatment or did not respond to previous treatment, and that has a certain type of abnormal BRAF gene. A healthcare provider will perform a test to confirm that OJEMDA is right for the patient.

OJEMDA was approved based on how many patients' tumors responded to treatment and how long those responses lasted. Continued approval may depend on confirmation of clinical benefit in a confirmatory study. It is not known if OJEMDA is safe and effective in children younger than 6 months of age.

IMPORTANT SAFETY INFORMATION

OJEMDA may cause serious side effects, including:

• Bleeding problems (hemorrhage). Bleeding is common during treatment with OJEMDA and can also be serious. Patients should contact their healthcare provider or get medical help right away if they have any signs of bleeding, such as headache, dizziness or weakness, coughing up or vomiting blood (or vomit that looks like coffee grounds), or red or black stools that look like tar.
• Skin reactions, including sensitivity to sunlight (photosensitivity). OJEMDA can cause skin reactions that may become severe. Patients should tell their healthcare provider about new or worsening skin reactions, such as rash, acne, bumps, blisters, or peeling, redness, or irritation. Patients should limit time in sunlight and use sun protection, such as sunscreen, sunglasses, and protective clothing, during treatment.
• Liver problems. OJEMDA can cause liver problems. A healthcare provider will do blood tests to check the liver before and during treatment. Patients should tell their healthcare provider right away about yellowing of the skin or the whites of the eyes, dark or brown (tea-colored) urine, nausea or vomiting, loss of appetite, feeling tired, bruising, bleeding, or pain in the upper right stomach area.
• Slowed growth in children. OJEMDA can slow growth in children. A child's growth will be checked routinely during treatment with OJEMDA.
• Harm to an unborn baby. OJEMDA can harm an unborn baby. A healthcare provider will check whether a patient is pregnant before starting OJEMDA. Females who are able to become pregnant should use effective nonhormonal birth control during treatment and for 28 days after the last dose, because OJEMDA can cause some hormonal birth control to not work as well. Males with female partners who are able to become pregnant should use effective birth control during treatment and for 2 weeks after the last dose. Patients should tell their healthcare provider right away if they become pregnant or think they might be pregnant during treatment.

Before receiving OJEMDA, patients should tell their healthcare provider:

• about all of their medical conditions, including if they have bleeding, skin, or liver problems; or are pregnant, plan to become pregnant, or are breastfeeding.
• about all the medicines they take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and any hormonal birth control. OJEMDA may affect how other medicines work, and other medicines may affect how OJEMDA works.

Patients should not breastfeed during treatment with OJEMDA and for 2 weeks after the last dose.

OJEMDA may cause fertility problems in males and females, which may affect the ability to have children.

The most common side effects of OJEMDA include rash, hair color changes, feeling tired, viral infection, vomiting, headache, bleeding, fever, dry skin, constipation, nausea, acne, and upper respiratory tract infection.

The most common severe abnormal blood test results include decreased phosphate, decreased red and white blood cells, increased creatine phosphokinase, increased liver function tests, decreased albumin, decreased potassium, and decreased sodium.

These are not all of the possible side effects of OJEMDA. Talk to a healthcare provider for medical advice about side effects.

Patients are encouraged to report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch, or to Day One Biopharmaceuticals at 1-877-204-2820.

Please see Patient Information and Instructions for Use. 

Disclosures
This release contains general information about the Servier Group and its entities (hereinafter "Servier and its Affiliates") and is intended for informational purposes only. The information is thought to be reliable; however, Servier and its Affiliates make no representation as to the accuracy or completeness of the information contained herein or otherwise provided and accept no responsibility or liability, in contract, in tort, in negligence, or otherwise, should the information be found to be inaccurate or incomplete in any respect.

Servier and its Affiliates are not acting as an advisor to the recipient of this information, and the ultimate decision to proceed with any transaction rests solely with the recipient of this information. Therefore, prior to entering into any proposed transaction, the recipient of this information should determine, without reliance upon Servier or its Affiliates, the economic risks and merits, as well as the legal, tax, and accounting characterizations and consequences, of the transaction and that it is able to assume these risks.

This statement also contains forward-looking statements that are subject to varying levels of uncertainty and risk. Investigational new drugs and indications are subject to further scientific and medical review and regulatory approval. They are not approved for use by the FDA.

Any reliance placed on this document is done entirely at the risk of the person placing such reliance. The information contained in this document is neither an offer to sell nor the solicitation of an offer to enter into a transaction.

The content of this document is a summary only, is not complete, and does not include all material information about Servier and its Affiliates, including potential conflicts of interest.

To the maximum extent permitted by applicable laws and regulations, Servier and its Affiliates disclaim all representations, warranties, conditions and guarantees, whether express, implied, statutory or of other kind, nor does it accept any duty to any person, in connection with this document. Without prejudice to the generality of the foregoing, Servier and its Affiliates do not warrant or represent that the information or opinions contained in this document is accurate or complete.

To the maximum extent permitted by applicable laws and regulations, Servier and its Affiliates shall not be liable for any loss, damage or expense whatsoever, whether direct or indirect, howsoever arising, whether in contract, tort (including negligence), strict liability or otherwise, for direct, indirect, incidental, consequential, punitive or special damages arising out of or in connection with this document, including (without limitation) any course of action taken on the basis of the same. The estimates, strategies, and views expressed in this document are based upon past or current data and information and are subject to change without notice.

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.

SOURCE Servier Pharmaceuticals