Late-breaking data from the pivotal Phase 3 INDIGO study strengthen clinical evidence of vorasidenib in IDH-mutant diffuse glioma
First data of vorasidenib in combination with pembrolizumab to profile the safety and tolerability results in a Phase 1 perioperative study
BOSTON, November 10, 2023 –Servier will showcase new data from its vorasidenib clinical development program in a plenary townhall at the 28th Annual Meeting of the Society for Neuro-Oncology (SNO), November 16-19, 2023, in Vancouver, Canada. These data underscore the company’s unwavering commitment to develop innovative therapies that address areas of high unmet need in oncology.
The data to be presented will include an analysis of the impact that vorasidenib has on the tumor growth rate (TGR) of IDH-mutant gliomas. TGR was a secondary endpoint in the pivotal Phase 3 INDIGO study evaluating vorasidenib, an investigational, oral, selective, highly brain-penetrant dual inhibitor of mutant isocitrate dehydrogenase 1 or 2 (IDH1/2) enzymes in patients with residual or recurrent IDH1/2 mutant low-grade glioma. The positive late-breaking topline results from the INDIGO study were previously presented during a plenary session at the 2023 Annual Meeting of the American Society of Clinical Oncology (ASCO), and simultaneously published in the New England Journal of Medicine.
“For more than 20 years, due to a lack of new treatment options, many patients with IDH-mutant gliomas have had to make the difficult choice of taking a ‘watch and wait’ approach to monitor the growth and symptoms of the disease as a means to delay experiencing the potentially toxic acute and long-term side effects associated with more aggressive regimens,” said Susan Pandya, M.D., Head of Cancer Metabolism Global Development Oncology & Immuno-Oncology, Servier. “We are excited to present these new data at SNO, which will further establish the potential clinical benefit of vorasidenib and provide new insights into how IDH-mutant gliomas behave biologically and clinically.”
Additional data to be presented in an oral session are the first safety results from a Phase 1 safety lead-in and perioperative study of vorasidenib in combination with pembrolizumab in patients with recurrent or progressive enhancing IDH1-mutant astrocytomas. Astrocytomas are one of the most common types of IDH-mutant glioma.
Servier abstracts being presented at SNO are listed below (all times in Pacific Standard Time) and are available online on the SNO website here.
“At Servier, we research where others can’t or won’t, taking on the challenge of developing transformative treatment options for patients with few-to-no options available,” said Patrick Therasse, M.D. PhD, Global Head of Late Stage and Life Cycle Management Oncology, Servier. “These analyses will further illustrate our ambitions to shift the treatment paradigm for IDH-mutant gliomas and offer these patients much-needed hope.”
Abstract #CTIM-14 (oral): Phase 1 safety lead-in and randomized open-label perioperative study of vorasidenib combined with pembrolizumab in recurrent or progressive enhancing IDH1-mutant astrocytomas: safety lead-in results
Abstract #LTBK-06 (late-breaker): Impact of vorasidenib treatment on mutant IDH1 or IDH2 diffuse glioma tumor growth rate: results from the randomized, double-blind, Phase 3 INDIGO study
Abstract #CTNI-51: A randomized, double-blind Phase 3 study of vorasidenib versus placebo in patients with IDH1 or IDH2 low-grade glioma (INDIGO): exploratory analysis of variant allele frequency and progression-free survival
Abstract #QOL-26: A randomized, double-blind, Phase 3 study of vorasidenib versus placebo in patients with mutant IDH1 or IDH2 diffuse glioma (INDIGO): analysis of health-related quality of life, neurocognition, and seizure activity
About Servier in Oncology
Servier is a global leader in oncology focused on delivering meaningful therapeutic progress for the patients it serves. Governed by a non-profit foundation, Servier approaches innovation with a long-term vision, free of influence from investors and outside pressure to chase short-term monetary targets.
As a leader in oncology, 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 of high unmet need throughout oncology with the potential to change the lives of the patients it serves. Within these areas, Servier is the leader in mutant IDH inhibition, with the first ever mutant IDH1 inhibitor approved in the U.S. and the European Union, and the company continues to drive the science behind targeted mutant IDH inhibition.
Servier’s commitment to therapeutic progress guides its collaboration strategy. While many companies across the industry are scaling back investments, Servier is actively building alliances, completing acquisitions, conducting licensing deals and entering new partnerships that can help to accelerate access to therapies for patients in need. With the company’s commercial expertise, global reach, scientific expertise and commitment to clinical excellence, Servier is dedicated to bringing the promise of tomorrow to the patients it serves.
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 Kabel, A. M. , Modais, K. , Salim, A. , Ahmad, R. , Ahmad, A. , & Alnumari, K. A. (2018). Astrocytoma: Insights into Risk Factors, Pathogenesis, Diagnosis and Management. Journal of Cancer Research and Treatment, 6(3), 70-73. http://pubs.sciepub.com/jcrt/6/3/2.