RELEASE: Servier's Pivotal Phase 3 INDIGO Trial Achieves Primary Endpoint of Progression-Free Survival (2)

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RELEASE: Servier's Pivotal Phase 3 INDIGO Trial Achieves Primary Endpoint of Progression-Free Survival (2)

(Information sent by the signatory company)

Servier's pivotal Phase 3 INDIGO trial, investigating vorasidenib in low-grade gliomas with IDH mutation, achieves primary endpoint of progression-free survival (PFS) and key secondary endpoint of time to next intervention (TTNI)

PARIS and BOSTON, March 14, 2023/PRNewswire/ -- Servier, a global pharmaceutical group, today announced the INDIGO Phase 3 clinical trial investigating vorasidenib monotherapy for patients with mutation-positive low-grade glioma Residual or recurrent IDH, met his 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 statistically significant and clinically relevant.

"Therapeutic progress in the field of low-grade glioma has been stalled for decades. Results from the phase 3 INDIGO trial, in which both the primary endpoint of progression-free survival and the key secondary endpoint of time to the next intervention, provide an opportunity to change the treatment paradigm for patients with IDH-mutated low-grade glioma by potentially delivering the first targeted therapy," said Susan Pandya, MD, Vice President of Clinical Development and Chief Development Officer Servier Global Center for Cancer Metabolism, Oncology and Immuno-Oncology. "We are very grateful to the patients, caregivers, researchers and study teams who have made this remarkable achievement possible through their participation in the INDIGO clinical trial."

The interim analysis, which was prespecified in the INDIGO trial design, demonstrated a statistically significant and clinically important improvement in both PFS and time to next intervention in patients randomized to vorasidenib monotherapy compared with 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 the only treatment for glioma prior to study enrollment. The safety profile of vorasidenib monotherapy was consistent with previously published data.

"This potential therapeutic advance is further concrete evidence of the success of our oncology strategy, which aims to focus our science on difficult and hard-to-treat cancers, such as those in which an IDH mutation is present," said Patrick Therasse, M.D. PhD, Vice President and Director of the Therapeutic Area of ​​Oncology and Immuno-oncology at Servier. "Results from the phase 3 INDIGO trial offer patients with IDH mutant low-grade glioma the potential hope of a new treatment option for the first time in more than 20 years."

Results from the phase 3 INDIGO trial will be presented at an upcoming medical meeting.

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

About the Phase 3 INDIGO 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 IDH1 mutation or IDH2 who have undergone surgery as the only treatment. (NCT04164901).

About Glioma1 Gliomas are tumors that arise from glial or precursor cells of the central nervous system (CNS). The 2021 WHO classification recognizes four general groups of gliomas, one of which is diffuse adult-type gliomas. These diffuse gliomas are the most common primary malignant brain tumors in adults. The pathogenesis and prognosis of these tumors are closely related to mutations (or lack thereof) in the metabolic enzyme isocitrate dehydrogenase (IDH), and molecular tests are required for proper diagnosis. As of 2021, adult-type diffuse gliomas are subdivided solely into three categories:

1 Neuro Oncology. The 2021 WHO Classification of Tumors of the Central Nervous System: a summary. último acceso-3.13.23

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

As the world leader in cardiology, Servier's ambition is to become a recognized, focused and innovative player in oncology, focusing on difficult and hard-to-treat cancers. For this reason, the Group allocates more than 50% of its RD budget to oncology.

Neuroscience and immunoinflammatory diseases are the future drivers of growth. In these areas, Servier focuses on a limited number of diseases where a precise patient profile makes it possible to deliver a targeted therapeutic response through precision medicine.

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

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

Headquartered in France, Servier has a strong geographic presence in more than 150 countries and achieved revenues of €4.9 billion in 2022.

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About Servier in the US As a leader in oncology, Servier is committed to finding solutions that address today's challenges. The company's portfolio of oncology products includes innovative medicines designed to deliver more life-saving treatments to more patients, across the spectrum of disease and across a variety of tumor types. Servier has significantly accelerated its investment in difficult and difficult-to-treat cancers, dedicating more than 50% of its research and development to making significant advances in areas that can really move the needle for our patients.

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

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