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.