Table 2.

Unanswered Questions in IDHm Gliomas After INDIGO Study Data

Unanswered questions emerging from INDIGO data
Optimal patient population and long-term benefits
What are the patients most likely to benefit from vorasidenib in the upfront setting?
Does the use of vorasidenib impact OS in the INDIGO population?
What is the optimal treatment sequence and duration of treatment with IDH inhibitors?
Will treatment with vorasidenib affect response to subsequent treatment with radiation therapy and chemotherapy?
What is the magnitude of benefit of vorasidenib in patients with gross total resection or minimal residual disease after surgery?
Are there cumulative long-term adverse events associated with the use vorasidenib?
Does vorasidenib affect fertility? Is it associated with teratogenic risk?
Use in other setting and trial design
What is the additive value of vorasidenib over standard of care therapy alone?
What is the role of vorasidenib in combination with SOC treatment in the up-front and recurrent settings?
Is there a benefit of starting vorasidenib after radiation and chemotherapy as maintenance treatment?
Is there a role for vorasidenib in patients with grade 3 or enhancing tumors?
Should patients who are receiving ivosidenib or olutasidenib off-label be switched to vorasidenib?
Biomarkers
What imaging methods and biomarkers can be used to improve response assessment?
What mechanisms mediate resistance to IDH inhibitors in glioma? How does this affect the treatment sequence?
What is the role of DNA methylation analysis in identifying potential responders versus non-responders to vorasidenib? Are there other potential predictive biomarkers?
Social burden
What is the patients’ burden (financial, family planning, etc) of long-term treatment with IDH inhibitors?
What is the cost-effectiveness associated with vorasidenib?
How to improve access to treatment in developing countries?
Unanswered questions emerging from INDIGO data
Optimal patient population and long-term benefits
What are the patients most likely to benefit from vorasidenib in the upfront setting?
Does the use of vorasidenib impact OS in the INDIGO population?
What is the optimal treatment sequence and duration of treatment with IDH inhibitors?
Will treatment with vorasidenib affect response to subsequent treatment with radiation therapy and chemotherapy?
What is the magnitude of benefit of vorasidenib in patients with gross total resection or minimal residual disease after surgery?
Are there cumulative long-term adverse events associated with the use vorasidenib?
Does vorasidenib affect fertility? Is it associated with teratogenic risk?
Use in other setting and trial design
What is the additive value of vorasidenib over standard of care therapy alone?
What is the role of vorasidenib in combination with SOC treatment in the up-front and recurrent settings?
Is there a benefit of starting vorasidenib after radiation and chemotherapy as maintenance treatment?
Is there a role for vorasidenib in patients with grade 3 or enhancing tumors?
Should patients who are receiving ivosidenib or olutasidenib off-label be switched to vorasidenib?
Biomarkers
What imaging methods and biomarkers can be used to improve response assessment?
What mechanisms mediate resistance to IDH inhibitors in glioma? How does this affect the treatment sequence?
What is the role of DNA methylation analysis in identifying potential responders versus non-responders to vorasidenib? Are there other potential predictive biomarkers?
Social burden
What is the patients’ burden (financial, family planning, etc) of long-term treatment with IDH inhibitors?
What is the cost-effectiveness associated with vorasidenib?
How to improve access to treatment in developing countries?
Table 2.

Unanswered Questions in IDHm Gliomas After INDIGO Study Data

Unanswered questions emerging from INDIGO data
Optimal patient population and long-term benefits
What are the patients most likely to benefit from vorasidenib in the upfront setting?
Does the use of vorasidenib impact OS in the INDIGO population?
What is the optimal treatment sequence and duration of treatment with IDH inhibitors?
Will treatment with vorasidenib affect response to subsequent treatment with radiation therapy and chemotherapy?
What is the magnitude of benefit of vorasidenib in patients with gross total resection or minimal residual disease after surgery?
Are there cumulative long-term adverse events associated with the use vorasidenib?
Does vorasidenib affect fertility? Is it associated with teratogenic risk?
Use in other setting and trial design
What is the additive value of vorasidenib over standard of care therapy alone?
What is the role of vorasidenib in combination with SOC treatment in the up-front and recurrent settings?
Is there a benefit of starting vorasidenib after radiation and chemotherapy as maintenance treatment?
Is there a role for vorasidenib in patients with grade 3 or enhancing tumors?
Should patients who are receiving ivosidenib or olutasidenib off-label be switched to vorasidenib?
Biomarkers
What imaging methods and biomarkers can be used to improve response assessment?
What mechanisms mediate resistance to IDH inhibitors in glioma? How does this affect the treatment sequence?
What is the role of DNA methylation analysis in identifying potential responders versus non-responders to vorasidenib? Are there other potential predictive biomarkers?
Social burden
What is the patients’ burden (financial, family planning, etc) of long-term treatment with IDH inhibitors?
What is the cost-effectiveness associated with vorasidenib?
How to improve access to treatment in developing countries?
Unanswered questions emerging from INDIGO data
Optimal patient population and long-term benefits
What are the patients most likely to benefit from vorasidenib in the upfront setting?
Does the use of vorasidenib impact OS in the INDIGO population?
What is the optimal treatment sequence and duration of treatment with IDH inhibitors?
Will treatment with vorasidenib affect response to subsequent treatment with radiation therapy and chemotherapy?
What is the magnitude of benefit of vorasidenib in patients with gross total resection or minimal residual disease after surgery?
Are there cumulative long-term adverse events associated with the use vorasidenib?
Does vorasidenib affect fertility? Is it associated with teratogenic risk?
Use in other setting and trial design
What is the additive value of vorasidenib over standard of care therapy alone?
What is the role of vorasidenib in combination with SOC treatment in the up-front and recurrent settings?
Is there a benefit of starting vorasidenib after radiation and chemotherapy as maintenance treatment?
Is there a role for vorasidenib in patients with grade 3 or enhancing tumors?
Should patients who are receiving ivosidenib or olutasidenib off-label be switched to vorasidenib?
Biomarkers
What imaging methods and biomarkers can be used to improve response assessment?
What mechanisms mediate resistance to IDH inhibitors in glioma? How does this affect the treatment sequence?
What is the role of DNA methylation analysis in identifying potential responders versus non-responders to vorasidenib? Are there other potential predictive biomarkers?
Social burden
What is the patients’ burden (financial, family planning, etc) of long-term treatment with IDH inhibitors?
What is the cost-effectiveness associated with vorasidenib?
How to improve access to treatment in developing countries?
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