The first step in deciding whether to participate in the study is to learn about low- grade glioma and isocitrate dehydrogenase (IDH) mutations, and discover why the INDIGO Study is being conducted.

What is the goal of the INDIGO Study?

The goal of the phase 3 study is to determine whether vorasidenib could provide a therapeutic alternative to “watch and wait” to help control low-grade glioma, and potentially delay the need for chemotherapy and/or radiation.

Vorasidenib is an investigational drug that targets IDH1 and IDH2 gene mutations. To participate in the INDIGO Study, you must have a Grade 2 (low-grade) glioma with an IDH gene mutation. You also should have had at least one surgery for glioma 1-5 years ago, and not have had any other anti-cancer therapy, including chemotherapy or radiation. 1,2

The effectiveness and safety of vorasidenib have not been established. There is no guarantee that vorasidenib will receive health authority approval or become commercially available in any country for the use being investigated.

See the Key Requirements for Participation


Why is the INDIGO Study evaluating an IDH mutation inhibitor?

The INDIGO Study is evaluating whether a drug that inhibits IDH mutations is safe and effective as a treatment for low-grade glioma.

Grade 2 low-grade gliomas are less common than other types of brain tumors. However, within the population of patients who have low-grade gliomas, 70-80% have an IDH mutation, with about 3,500 cases of IDH mutated low-grade gliomas a year in the US.3,9

Scientific studies have suggested that mutations in IDH occur early in the formation of a tumor and might drive tumor growth. Inhibiting these mutations may slow down the growth of the tumor. Other therapies, such as chemotherapy and radiation, could potentially introduce additional mutations in the tumor, possibly making an IDH inhibitor less effective.2,7 For this reason the INDIGO Study is focusing on people who have not had any of these prior therapies.


What is Grade 2 glioma?

The INDIGO Study focuses on people with Grade 2 gliomas, of which there are about 3,500 cases of IDH mutated low-grade gliomas a year in the US.4,5

Grade 2 gliomas are a type of primary brain tumor. Brain tumors happen when normal cells in the brain change into abnormal cells and grow out of control. Grade 2 gliomas arise from two different types of brain cells known as astrocytes and oligodendrocytes.10

Grade 2 gliomas are considered low-grade because they grow slowly and spread into healthy parts of the brain. Sometimes slow growing Grade 2 gliomas change into faster growing tumors, known as high-grade gliomas. All gliomas cause symptoms through a combination of pressure on the surrounding brain and direct infiltration of the brain tissue.6

What is the typical course of treatment for low-grade glioma?

Low- grade gliomas are usually treated with surgery, followed by a period of observation or treatment with chemotherapy and/or radiation. If the tumor is located in an area where it is safe to remove, the neurosurgeon will attempt to remove as much as possible. Sometimes this is all the treatment you will need at the beginning and your doctors will monitor your tumor with MRI scans every few months.8

If the tumor appears to be growing, your doctors will then consider either doing another surgery or starting treatment with radiation, chemotherapy, or both.


More resources to help you become as informed as possible

Advocacy and support groups and research centers are valuable resources for further information. You can also contact us with any additional questions you might have.

Disclaimer

The effectiveness and safety of vorasidenib have not been established. There is no guarantee that vorasidenib will receive health authority approval or become commercially available in any country for the use being investigated.

References

  1. Study of AG-881 in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO) – https://clinicaltrials.gov/ct2/show/NCT04164901
  2. Yen KE, Bittinger MA, Su SM, Fantin VR. Cancer-associated IDH mutations: biomarker and therapeutic opportunities. Oncogene. 2010;29(49):6409-6417
  3. Ostrom QT, Gittleman H, Liao P, et al. CBTRUS Statistical Report: Primary brain and other central nervous system tumors diagnosed in the United States in 2010-2014. Neuro Oncol. 2017 Nov 6;19(suppl_5):v1-v88.
  4. Oligodendroglioma. National Institutes of Health. https://rarediseases.info.nih.gov/diseases/9953/oligodendroglioma. Accessed September 24, 2019.
  5. Diffuse astrocytoma. https://rarediseases.info.nih.gov/diseases/5907/diffuse-astrocytoma. Accessed September 24, 2019.
  6. Glioma Tumors – Symptoms and Clinical Trials. Ivy Brain Tumor Center. https://www.ivybraintumorcenter.org/clinical-trials-gliomas/. Accessed August 23, 2019.
  7. Cancer Genome Atlas Research Network, Brat DJ, Verhaak RG, et al. Comprehensive, Integrative Genomic Analysis of Diffuse Lower-Grade Gliomas. N Engl J Med. 2015; 372(26):2481-2498.
  8. Oberheim Bush NA, Chang S. Treatment strategies for low-grade glioma in adults. J Oncol Pract. 2016 12:1235-1241.
  9. Yan H, Parsons DW, Jin G, et al. IDH1 and IDH2 Mutations in Gliomas. N Engl J Med 2009; 360:765-773.
  10. Louis et al. The 2016 World Health Organization Classification of Tumors of the Central Nervous System: A summary. Acta Neuropathol (2016) 131:803–820