Servier's Pivotal Phase 3 INDIGO Trial Investigating vorasidenib in IDH-Mutant Low-Grade Glioma Meets Primary Endpoint of Progression-Free Survival (PFS) and Key Secondary Endpoint of Time to Next Intervention (TTNI)

• Clinically meaningful achievement of primary and secondary endpoints is first major advance in treatment of low-grade glioma in more than 20 years
  
  
• Endpoints met in a prespecified interim analysis
  
  
• vorasidenib granted fast track designation by U.S. Food & Drug Administration (FDA)

PARIS and BOSTON, March 14, 2023 /PRNewswire/ -- Servier, a global pharmaceutical group, announced today that the Phase 3 INDIGO clinical trial investigating vorasidenib in monotherapy for patients with residual or recurrent IDH mutant low-grade glioma met its primary endpoint of progression free survival (PFS) and the key secondary endpoint of time to next intervention (TTNI). The results of the prespecified interim analysis were both statistically significant and clinically meaningful.

"Therapeutic progress in the low-grade glioma space has been stagnant for decades. The results of the Phase 3 INDIGO trial, meeting both the primary endpoint of progression-free survival and the key secondary endpoint of time to next intervention, presents an opportunity to shift the treatment paradigm for patients with IDH mutant low-grade glioma by potentially delivering the first targeted therapy," said Susan Pandya, M.D., Vice President Clinical Development and Head of Cancer Metabolism Global Development Oncology & Immuno-Oncology, Servier. "We are grateful to the patients, caregivers, investigators and study teams who made this remarkable achievement possible through their participation in the INDIGO clinical trial."

The interim analysis, which was prespecified in the design of the INDIGO trial, demonstrated a statistically significant and clinically meaningful improvement in both progression-free survival and time to next intervention in patients randomized to vorasidenib monotherapy compared to patients randomized to placebo. Patients enrolled in the INDIGO study had residual or recurrent grade 2 oligodendroglioma or astrocytoma with an IDH1 or IDH2 mutation and had undergone surgery as their only treatment for glioma prior to study enrollment. The safety profile of vorasidenib in monotherapy was consistent with previously published data.

"This potential therapeutic breakthrough is yet another concrete proof-point of the success of our oncology strategy, which aims to focus our science on difficult and hard-to-treat cancers such as those where an IDH mutation is present," said Patrick Therasse, M.D. PhD, Vice-President and  Head, Late Stage and Life Cycle Management Oncology & Immuno-oncology Therapeutic Area, Servier. "The results from the Phase 3 INDIGO trial offer patients with IDH mutant low-grade glioma potential hope for a new treatment option for the first time in more than 20 years."

The Phase 3 INDIGO trial results will be presented at an upcoming medical meeting.

Due to the accelerated enrollment and interim efficacy analysis outcome, the INDIGO clinical trial is well ahead of schedule. Servier is working to determine filing timelines and adapt the vorasidenib supply capacity.

About the INDIGO Phase 3 Trial
INDIGO is a phase 3, multicenter, randomized, double-blind, placebo-controlled study comparing the efficacy of vorasidenib to placebo in participants with residual or recurrent grade 2 glioma with an IDH1 or IDH2 mutation who have undergone surgery as their only treatment. (NCT04164901).

About Glioma¹
Gliomas are tumors that arise from glial or precursor cells within the central nervous system (CNS). The 2021 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, 1p19q-codeleted (CNS WHO grades 2-3)
• Glioblastoma IDH-wildtype (CNS WHO grade 4)

1 Neuro Oncology. The 2021 WHO Classification of Tumors of the Central Nervous System: a summary. https://academic.oup.com/neuro-oncology/article/23/8/1231/6311214 Last accessed-3.13.23

Media Contacts:
Group:
Eric Fohlen-Weill
presse@servier.com 

USA:
Nathan Mellor
nathan.mellor@servier.com 

About Servier
Founded to serve health, Servier is a global pharmaceutical group governed by a Foundation that aspires to have a meaningful social impact, both for patients and for a sustainable world. With its unique governance model, it can fully serve its vocation with a long-term vision: being committed to therapeutic progress to serve patient needs. The 21,400 employees of the Group are committed to this shared vocation, a source of inspiration every day.

As a world leader in cardiology, Servier's ambition is to become a renowned, focused and innovative player in oncology by targeting difficult and hard-to-treat cancers. That is why the Group allocates over 50% of its R&D budget to Oncology.

Neuroscience and immuno-inflammatory diseases are the future growth drivers. In these areas, Servier is focused on a limited number of diseases in which accurate patient profiling makes it possible to offer a targeted therapeutic response through precision medicine.

To promote access to quality care for all at a lower cost, the Group also offers a range of quality generic drugs covering most pathologies, relying on strong brands in France, Eastern Europe, Brazil and Nigeria.

In all these areas, the Group includes the patient voice at each stage of the life cycle of a medicine.

Headquartered in France, Servier relies on a strong geographical footprint in over 150 countries and achieved a revenue of €4.9 billion in 2022.

More information on the new Group website: servier.com

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About Servier in the U.S.
As a leader in oncology, Servier is committed to finding solutions that will address today's challenges. The company's oncology portfolio includes innovative medicines designed to bring more life-saving treatments to a greater number of patients, across the entire spectrum of disease and in a variety of tumor types. Servier has significantly accelerated its investment in difficult and hard-to-treat cancers with more than 50% of its research and development dedicated to delivering significant advances in areas that may truly move the needle for our patients.

Servier believes co-creation is fundamental to driving innovation and is actively building alliances, acquisitions, licensing deals and partnerships that bring solutions and accelerate access to therapies. With the company's commercial expertise, global reach, scientific expertise and commitment to clinical excellence, Servier in the U.S. is dedicated to bringing the promise of tomorrow to the patients that we serve.

For more information: www.servier.us. 

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