Biomede trial

This trial is co-funded by the Enfants sans Cancer 2014 and 2017 races, and Enfants sans Cancer City 2019.

 

BIOMEDE is the most ambitious clinical trial offered to children with diffuse intrinsic pontine glioma (DIPG). This malignant brain tumor is very aggressive and located in a vital area of the brainstem called the pons. This brain region controls vital functions such as balance, breathing, heart rate, or blood pressure and is also traversed by nerves controlling vision, hearing, speech, swallowing, and movement. Due to its location and the highly invasive potential of this tumor, surgical treatment is often impossible. To address the grim prognosis of this disease, Imagine for Margo has decided to support Dr. Jacques Grill and his team based at the Institut Gustave Roussy for the “BIOMEDE” trial (€1,605,000 since 2014), which has changed clinical practices for this cancer.

 

The first victories thanks to BIOMEDE 1

Conducted between 2014 and 2019, the first phase of BIOMEDE demonstrated the utility of diagnostic biopsy as a standard, allowing for systematic molecular profiling of each child’s tumors. Based on the results, Dr. Jacques Grill and his team compared the effectiveness of three drugs (erlotinib, dasatinib, and everolimus) in combination with radiotherapy sessions. This first phase involved 70 centers located in 9 European countries, Australia, and New Zealand, and included 233 patients. This randomized phase 3 trial is the largest in the world conducted for diffuse intrinsic pontine glioma. The toxicity profile and the slight improvement in the median overall survival obtained during the study led to the selection of everolimus as the reference treatment for the second part of the trial, BIOMEDE 2. This treatment notably allowed, for the first time in the world, to save the first children from this cancer, including young Lucas.

Furthermore, the molecular profiling of tumors obtained by biopsy allowed for the analysis of mutations associated with the severity of these gliomas. Consequently, at the end of this project, and in addition to BIOMEDE 2, new research projects are emerging (e.g., PATOI, funded by Fight Kids Cancer in 2023) to find therapies that better match these specificities.

 

BIOMEDE IA: Artificial intelligence serving research

The comprehensive sequencing of tumors, medical follow-up, and imaging analyses of patients included in the BIOMEDE trial have provided a vast amount of data, the analysis of which is essential for a better understanding and treatment of diffuse intrinsic pontine glioma. This is the objective of BIOMEDE IA, which uses artificial intelligence to analyze this information obtained after each tumor biopsy. The algorithms will help identify and match certain factors undetectable by human analysis.

 

BIOMEDE 2, accelerating the cure for this cancer

This trial, open since September 23, 2022, aims to compare the therapeutic effect of ONC201 with Everolimus, the reference treatment, still in combination with radiotherapy. Open in 10 European countries, this trial plans to include 368 adult and pediatric patients over 4 years. ONC 201 is the first drug in a new class of anticancer agents that targets the energy metabolism of cancer cells and has shown signs of efficacy in the United States in some patients with relapsed malignant midline brain tumors. This efficacy is due to the presence of a mutation within the tumor, H3K27M, which will be detected through tumor sequencing from a biopsy.

This trial is expected to take place in 40 European centers in France, Great Britain, Italy, Germany, Austria, Spain, Switzerland, Denmark, and the Netherlands.

 

About BIOMEDE 2:

The total cost of the BIOMEDE 2.0 program is €6 million, excluding the cost of medications provided by manufacturers. The total budget is not yet finalized, and funding is still needed.

In order of funding amount to date, BIOMEDE 2 is supported by:

• the Gustave Roussy Foundation,
• the National Cancer Institute (PHRC),
• Imagine for Margo,
• the Val de Marne and Haute-Savoie Cancer Leagues.

Imagine for Margo’s grant will fund the operations and partially the “study management team.”

 

Summary of the trial

Sponsor: Gustave Roussy

Principal Investigator: Dr. Jacques Grill

The principal investigator is Dr. Jacques Grill from the Institut Gustave Roussy in Villejuif. The co-investigators are Dr. Sue Picton (Leeds in Great Britain), Giorgio Perilongo (Padua in Italy), Pablo Hernaiz-Driever (Berlin in Germany), and Amadeo Azizi (Vienna in Austria).

Program duration: October 2014 – September 2031

Recruitment (ongoing): 601 patients (233 included in BIOMEDE 1 and 368 are planned in BIOMEDE 2)

Countries involved: France (13 centers), United Kingdom, Denmark, Sweden, Australia, Netherlands, Spain, Italy, Belgium, Austria, Switzerland, Finland, New Zealand, Norway, Canada, and Ireland

Imagine for Margo funding: €1,605,000

Other co-funder: National Cancer Institute (INCa), Gustave Roussy Foundation, Cancer League