Observational Study of the Newly Approved Drug Vorasidenib for Astrocytomas and Oligodendrogliomas

Astrocytomas and oligodendrogliomas are subtypes of brain tumors. They are classified into four grades according to a system established by the World Health Organization (WHO). The higher the grade, the more aggressive the tumor. In general, low-grade brain tumors have a better prognosis because they grow more slowly. If the tumors exhibit IDH mutations, the mutation provides an additional potential target for new medications. IDH genes play an important role in the energy production of tumor cells. Astrocytomas and oligodendrogliomas with a WHO grade of 2 and a confirmed IDH mutation are managed with palliative care. With a palliative treatment approach, a complete cure does not appear possible, and the primary goal is to improve quality of life (symptom relief) and to “keep the disease in check.” Treatment initially involves surgical removal of the tumors, followed by radiation therapy and chemotherapy, as well as regular monitoring via imaging (magnetic resonance imaging, MRI). The study drug vorasidenib represents a new treatment option for these diseases. The drug specifically inhibits IDH1 and IDH2 and is already approved for treatment in Germany.

The goal of this observational study is to monitor treatment with the study drug vorasidenib over the long term and to systematically collect information on the therapy in everyday clinical practice. This is an observational study, which means that no new drugs or forms of therapy are being tested. The primary endpoint of the study is the patients’ quality of life after up to 72 months.

Women and men aged 18 and older with a WHO Grade 2 astrocytoma or oligodendroglioma and a confirmed IDH mutation who have already undergone surgery and are scheduled to receive treatment with vorasidenib are eligible to participate in this study. There must be no indication for radiation therapy or chemotherapy, and the tumor must not show contrast enhancement on MRI.