Servier's Clinical and Real-World Data at 2025 SNO Congress Showcase Leadership in IDH-Mutant Glioma

• Presentations include seven company-sponsored abstracts and two investigator-initiated studies
• Oral presentation to highlight new analysis comparing volumetric and bidirectional assessments in patients with IDH-mutant Grade 2 glioma
• Safety data from a Phase 1b study evaluating the combination of VORANIGO and standard of care chemotherapy in high grade IDH-mutant gliomas will be featured in a rapid-fire oral presentation

BOSTON, Nov. 10, 2025 /PRNewswire/ -- Servier today announced that it will present new and updated data from its neuro-oncology program at the 30th Annual Meeting of the Society for Neuro-Oncology (SNO) on November 19 – 23 in Honolulu, Hawaii. Presentations will demonstrate progress across Servier's neuro-oncology portfolio, highlighting clinical and real-world evidence in isocitrate dehydrogenase (IDH) mutant glioma.

Notably, Servier will present an analysis from the Phase 3 INDIGO trial comparing volumetric (3D) and traditional bidirectional (2D) assessment in patients with Grade 2 IDH-mutant glioma receiving VORANIGO or placebo in an oral presentation on November 22. The findings show that 3D assessments may provide a more clinically meaningful determination of progression in Grade 2 glioma trials, potentially impacting future trial design and endpoint selection.

In addition, Servier will also share results from the Phase 1b part of an ongoing Phase 1b/2 study evaluating VORANIGO in combination with temozolomide in patients with newly diagnosed Grade 4 IDH mutant astrocytoma on November 22. These data represent the first published data evaluating the safety of combining an IDH inhibitor with current standard of care chemotherapy in higher grade IDH mutant gliomas.

"As a pioneer in targeted therapies for brain tumors, Servier – working with the neuro-oncology community – is using our unmatched clinical trial datasets to better understand how these medicines affect tumor growth," said Islam Hassan, Global Head of Development-Neuro-Oncology & Senior Director, LS/LCM at Servier. "The critical insights presented at SNO will enable efficient clinical trial designs across all IDH-mutant glioma grades, including in combination with temozolomide in higher grade settings, to help us deliver potential new treatment options faster to patients who are eagerly awaiting them, all while upholding the highest level of evidence."

A full list of abstracts 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 is the leader in IDH-mutant targeted therapies and devotes more than 65% of its research and development budget to Oncology. 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.us.

About Glioma ¹
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 and1p19q-codeleted (CNS WHO grades 2-3)
• Glioblastoma, IDH-wildtype (CNS WHO grade 4)

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.

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.

SOURCE Servier Pharmaceuticals