Updated efficacy and safety data from a long-term analysis of the Phase 3 INDIGO trial of VORANIGO® (vorasidenib) will be presented in a rapid oral presentation
Results from an ongoing Phase 1 trial evaluating investigational compound Emi-Le in adenoid cystic carcinoma will be shared in an oral presentation
BOSTON, May 21, 2026 /PRNewswire/ -- Servier today announced that it will present new and updated data at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting May 29 - June 2 in Chicago. Presentations will span across a range of rare cancers, including IDH-mutated glioma and adenoid cystic carcinoma (ACC).
"Servier's upcoming presentations at ASCO—which include updated long-term data in IDH-mutant glioma as well as emerging data from our newer oncology programs—underscore our dedication to delivering transformative medicines to patients with high unmet needs," said Becky Martin, PhD, Chief of Medical, Servier Pharmaceuticals. "Together, these programs demonstrate the continued evolution of Servier's oncology portfolio and our growing presence in rare oncology."
Notably, Servier will present updated efficacy and safety data from a long-term analysis of the Phase 3 INDIGO trial of VORANIGO® (vorasidenib) in a rapid oral presentation on May 31 at 4:36 p.m. CDT. Key findings from more than three years of follow-up data further support the robust progression-free survival (PFS) and time to next treatment intervention (TTNI) results observed with VORANIGO in previous analyses and confirm the durable and sustained treatment benefit of VORANIGO in Grade 2 IDH-mutant glioma.
Additional data from an exploratory analysis of the INDIGO trial demonstrating long-term treatment with VORANIGO generally led to a sustained decrease in seizure frequency and severity and preservation of quality of life will be presented as well.
Day One Biopharmaceuticals, now part of Servier Group, will also share results from an ongoing Phase 1 trial evaluating investigational compound Emi-Le (emiltatug ledadotin) in an oral presentation on June 1 at 8:24 a.m. CDT. The data reveal that Emi-Le demonstrates favorable tolerability and promising antitumor activity in patients with aggressive ACC who have no available treatment options and a poor prognosis. Further clinical development is ongoing.
In addition, a placebo-controlled trial of vorasidenib in IDH-mutated newly diagnosed Grade 3 astrocytoma led by the Alliance for Clinical Trials in Oncology will be featured in a trial in progress presentation.
A full list of ASCO abstracts can be found here. Please visit the Servier booth (#12079) and the Day One booth (#36155) onsite to learn more.
Servier will also present research updates at the European Hematology Association (EHA) 2026 Congress June 11-14 in Stockholm.
Media contact
Darby Malkin: [email protected]
About Servier
Servier is an independent international pharmaceutical group governed by a foundation. With its governance model, the Group is committed to therapeutic progress to serve patients and integrates the patient voice at every stage of the medicine life cycle.
As a leading global player in cardiology and venous diseases, Servier aims to become a leading innovator in oncology and neurology. The Group intends to offer targeted therapeutic solutions, particularly in rare cancers and neurological diseases, and invests nearly 20% of its brand-name sales in R&D.
Headquartered in France, Servier relies on its more than 20,000 employees and a solid geographic presence with medicines distributed in more than 130 countries. In the 2024/25 financial year, the Group achieved revenues of €6.9 billion.
More information on the Group website: servier.com
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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 Emi-Le
Emi-Le is a B7-H4-directed Dolasynthen ADC with a precise, target-optimized drug-to-antibody ratio (DAR 6) and a proprietary auristatin-F HPA payload with controlled bystander effect. This candidate is under evaluation in an ongoing Phase 1 clinical trial (previously with Mersana Therapeutics). The U.S. Food and Drug Administration has granted Fast Track designations to Emi-Le for the treatment of 1) adult patients with advanced or metastatic triple-negative breast cancer, and 2) advanced or metastatic HER2 low / HER2 negative breast cancer post-topo-1 ADC (including TNBC and certain HR+ breast cancers). It has also received Breakthrough Designation from the FDA for the treatment of patients with locally advanced, recurrent or metastatic adenoid cystic carcinoma with solid histology or high-grade transformation. For more information about the trial, visit clinicaltrials.gov (NCT05377996).
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.
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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.
SOURCE Servier Pharmaceuticals
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