French drugmaker Servier recently acquired Agios Pharmaceutical’s cancer unit for over $1.5 billion and thus gained access to clinical-phase candidate vorasidenib, the phase 3 study for which proved that the drug successfully met primary and secondary endpoints in a trial of patients suffering from IDH-Mutant Low-Grade Glioma compared to placebo.
The INDIGO phase 3 trial is for residual or recurrent grade 2 glioma with an IDH1 or IDH2 mutation. The clinical trial is a randomized study comparing the drug’s efficacy to a placebo in participants. All participants in the study had undergone surgery as their only form of treatment. By the end of the investigation, the drug successfully met the primary endpoint of progression-free survival (PFS). Not only this, but vorasidenib was also successful in reaching the secondary endpoint of time to next intervention (TTNI), in both instances data collected was clinically and statistically significant.
Precursor or glial cells within the central nervous system (CNS) are where Gliomas generally arise and the prognosis for this type of tumor is strongly connected to a lack of mutations in the metabolic enzyme isocitrate dehydrogenase (IDH). Generally, low-grade Gliomas are incurable and ultimately progress to high-grade disease and even though IDH mutations occur in 70% of patients only limited treatment options are available.
Patients that are at high risk of the disease are typically administered postoperative chemotherapy while the wait-and-watch approach is commonly used with low-risk patients. Evidence presented in the trial suggests that new ways to treat the disease may exist, in fact, Patrick Therasse, Servier’s VP and Head of Late Stage and Life Cycle Management Oncology & Immuno-oncology Therapeutic Area has called these findings a potential therapeutic breakthrough that is proof of the firm’s oncology strategy.
“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.
The INDIGO trial was completed way ahead of schedule due to the accelerated enrollment and interim efficacy analysis outcome, therefore trial results will soon be shared at medical meetings and Servier will start working towards filing timelines and adapting the apply capacity for the treatment.
It is indicative of Servier’s faith in vorasidenib that the approval of the drug in the U.S. is connected to milestone payments of up to $200 million for Agios. However, to trigger the payments the FDA must approve the drug latest by 2027. It is due to the firm’s commitment to the development of such drugs that 50% of the group’s Research and Development budget is allocated to the oncology department.
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