On September 23, BIOMEDE 2.0 opened. This international clinical trial, which we are financially supporting, is dedicated to malignant midline and brainstem gliomas. Its objective: to compare a promising drug, ONC201, with everolimus, a current targeted therapy treatment.
Today, 10 to 15% of malignant brain tumors in children are infiltrating brainstem gliomas. Despite progress in the management of pediatric cancers, this set of very aggressive tumors represents a real clinical challenge for researchers. Indeed, due to their location, infiltrating gliomas of the brainstem and midline are not operable and can therefore only be treated via radiotherapy. A real problem for the hundred children and adults who are diagnosed in France every year.
BIOMEDE 1.0: BETTER UNDERSTANDING FOR BETTER CARE
Conducted in 350 patients in Europe and Australia, the first phase of BIOMEDE compared the action of three drugs – everolimus, erlotinib and dasatinib on infiltrating brainstem and midline gliomas.
Thanks to this first step, it was possible to identify the feasibility of complete molecular profiling and to define a new standard of treatment combining radiotherapy with everolimus, a targeted therapy (antagonist of the mTOR pathway which is very often activated in these tumors).
“Our work has led to a better understanding of this disease, and to the discovery of a common anomaly blocking tumor cells in a state of extremely resistant stem cells to treatment. This H3K27M mutation interferes with the control of gene expression at the epigenetic level, representing a novel carcinogenesis mechanism specific to this type of cancer only,” explains Dr. Jacques Grill, pediatric oncologist and researcher in charge of the Brain Tumors program within the department. child and adolescent oncology by Gustave Roussy and coordinator of BIOMEDE.
BIOMEDE 2.0: STUDY OF THE NEW MEDICINE ONC201
In parallel with BIOMEDE 1.0, a new treatment, ONC201, against infiltrating gliomas of the brain stem and midline has been discovered and studied in the United States. In continuation of the work carried out, BIOMEDE 2.0 aims at demonstrating the possible superiority of the ONC201 drug associated with radiotherapy over the treatment associated with everolimus.
ONC201 showed effictivennes signals in patients with relapsed midline malignant brain tumor with H3K27M mutation, including 30% of patients with thalamus tumor.
“BIOMEDE 2.0 will make it possible to prove whether ONC201 brings a benefit in terms of disease control, and, potentially, its registration as the first specific therapy for this tumor” concludes Dr. Jacques Grill.
Open in 10 European countries, BIOMEDE 2.0 will include 368 adult and pediatric patients newly diagnosed with a malignant midline glioma with H3K27M mutation and will be recruited for 4 years.