Table 3. Open in new tab Potential...

Table 3.

Potential Pivotal Studies Evaluating Vorasidenib in IDHm Gliomas Beyond INDIGO Population

Setting	Treatment	Population	Notes
Adjuvant	Vorasidenib vs. placebo	Newly-diagnosed grade 2–3 gliomas after gross total resection in whom a watch-and-wait approach could be considered	Feasibility unclear
Concomitant	Standard of care chemotherapy (PCV, TMZ) combined with vorasidenib vs. placebo	Newly-diagnosed grade 2–3 gliomas requiring adjuvant treatment with chemotherapy/radiation therapy	Same design could be considered for patients with grade 4 astrocytoma
Maintenance	Vorasidenib vs. placebo	Newly-diagnosed grade 2–3 gliomas, after completion of standard of care treatment with chemotherapy and radiation therapy	Same design could be considered for patients with grade 4 astrocytoma

Setting	Treatment	Population	Notes
Adjuvant	Vorasidenib vs. placebo	Newly-diagnosed grade 2–3 gliomas after gross total resection in whom a watch-and-wait approach could be considered	Feasibility unclear
Concomitant	Standard of care chemotherapy (PCV, TMZ) combined with vorasidenib vs. placebo	Newly-diagnosed grade 2–3 gliomas requiring adjuvant treatment with chemotherapy/radiation therapy	Same design could be considered for patients with grade 4 astrocytoma
Maintenance	Vorasidenib vs. placebo	Newly-diagnosed grade 2–3 gliomas, after completion of standard of care treatment with chemotherapy and radiation therapy	Same design could be considered for patients with grade 4 astrocytoma