Servier Launches Phase III Clinical Trial in China for Vorasidenib, a First-in-Class IDH1/2 Dual Inhibitor, for the Treatment of Grade 2 Glioma
Servier
International Pharmaceutical Manufacturers
Source: Insight Database
Recently, the Chinese Drug Clinical Trial Registration and Information Disclosure Platform showed that Servier registered a Phase III clinical trial in China, aiming to evaluate Vorasidenib (S095032/AG881) TreatmentAsian subjects with residual or recurrent grade 2 glioma carrying IDH1 or IDH2 mutationsThe efficacy and safety. Earlier this year, the US FDA and the EU EMA have accepted the marketing authorization application for the drug. According to the Insight database,This is also the world's first IDH1/2 dual-target inhibitor to be submitted for marketing.。
InterceptImage source:Drug Clinical Trial Registration and Information Disclosure Platform
Glioma is a type of tumor that originates from glial cells and represents the most common primary intracranial tumor. In China, the annual incidence rate of glioma is 5–8 per 100,000 people, with a five-year mortality rate second only to pancreatic cancer and lung cancer among systemic tumors. Currently, the main treatment for glioma involves surgical resection combined with comprehensive therapies such as radiotherapy and chemotherapy. The clinical treatment goal is to prolong patients' progression-free survival and overall survival as much as possible while improving their quality of life.
Vorasidenib was acquired by Servier in 2020 through the acquisition of Agios.An orally administered, selective, highly brain-penetrant dual inhibitor targeting mutant isocitrate dehydrogenase 1 and 2 (IDH1 and IDH2）, to be developedFor the treatment of low-grade diffuse glioma with IDH mutation。
In March 2023, the global, randomized, double-blind, Phase III clinical trial INDIGO study of Vorasidenib (NCT04164901) met the primary endpoint and key secondary endpoints. The trial aimed to compare the efficacy of Vorasidenib with placebo in patients with residual or recurrent grade 2 oligodendroglioma or astrocytoma harboring IDH1 or IDH2 mutations who had only received surgical treatment. The trial data showed:
In the primary endpoint, progression-free survival (PFS) Aspect,The median PFS for patients in the vorasidenib monotherapy group was 27.7 months, compared to 11.1 months in the placebo group.。
Time to Next Intervention in Key Secondary Endpoint (TTNI) Aspect,The median TTNI has not been reached in the Vorasidenib group, while it was 17.8 months in the placebo group, with a statistically significant difference between the two.。
In addition, Vorasidenib monotherapy was well tolerated.
Phase III Clinical Trial INDIGO StudyOverview
Screenshot source: Insight Database Web Version
In February 2024, based on the data from the INDIGO pivotal Phase III clinical trial,The US FDA has accepted the new drug application for Vorasidenib and granted it priority review status for the treatment of patients with IDH-mutant glioma., with a PDUFA target date of August 20, 2024. Meanwhile, the European EMA has also accepted the marketing authorization application for Vorasidenib.
Servier's registration in China this time is for a multicenter, randomized, double-blind, placebo-controlled Phase III study. The purpose of the study is toAsian subjects with residual or recurrent grade 2 glioma carrying IDH1 or IDH2 mutationsEvaluate the efficacy, safety, and pharmacokinetics of Vorasidenib (PK) Characteristics.
Notably, in June 2024, Servier entered into a strategic partnership with AmoyDx, a molecular diagnostics company, to jointly develop the companion diagnostic for Vorasidenib in China.CDx) Reagent for IDH 1 and 2 gene mutations.
IDH is one of the important targets in the field of anti-tumor drug development. Globally, three IDH single-target inhibitors have been approved for the treatment of various types of cancer, but no IDH dual-target inhibitors have been approved yet.
According to the Insight database,Servier's Vorasidenib is the world's first IDH1/2 dual-target inhibitor to be submitted for marketing approval.。Hutchmed's HMPL306 is the second fastest IDH1/2 dual-target inhibitor in global research and has entered Phase III clinical trials. Notably,In China,Hutchmed's HMPL306 is the most studied drug in its classThe one with the fastest progress, its launchⅢ The time ratio of PhaseServier's was 4 months earlier。Other similar drugs in the same class that have entered the clinical stage include BPI-221351 from Betta Pharmaceuticals, LY3410738 from Eli Lilly, and NMS-173 from Nerviano Medical Sciences.
Global IDH1/2 Dual-Target Inhibitor Pipeline Research Progress
Screenshot from:Insight Database Web Version
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