Precision intiative “Two ongoing comprehensive genomic profiling studies from BSMO: GeNeo and BALLETT”

Precision intiative “Two ongoing comprehensive genomic profiling studies from BSMO: GeNeo and BALLETT”

  • We are proud to present our ongoing comprehensive sequencing studies within the Precision umbrella, GeNeo and BALLETT, both examining the value of broad agnostic NGS panel testing versus reimbursed organ-directed NGS. The comprehensive genomic profiling in GeNeo and BALLETT will be performed with different panels/platforms and participating laboratories.
    • GeNeo is a collaboration between BSMO and Roche with Foundation Medicine as laboratory partner, which currently is open for enrollment in 9 sites with another 4 sites planned (to be initiated in February 2021). In this trial, 1000 patients with advanced solid tumors are offered comprehensive genomic tumor profiling with FoundationOne CDx for the detection of molecular alterations. Patients with insufficient tumor material and only a liquid biopsy available are allowed. The detected alterations are discussed on a weekly basis at the national multidisciplinary Molecular Tumor Board. Treatment recommendations and enrolling trial opportunities are shared with the treating physicians together with the Foundation Medicine report.
      Between September 2020 and January 2021, 127 patients are included. Dr. Philippe Aftimos (Institut Jules Bordet) serves as principal investigator of GeNeo.
      A GeNeo National Molecular Tumor Board virtual meeting will be organized on Friday March 5th in the afternoon. More updates on this meeting and invitations will follow soon.
    • BALLETT is a collaboration between BSMO, Illumina, PierianDx and OncoDNA where comprehensive genomic profiling will be performed in Belgian participating NGS laboratories. Dr. Brigitte Maes (Jessa) is principal investigator. In BALLETT, 864 patients with advanced solid tumors will be recruited in 12 participating sites. Patients will be offered comprehensive genomic profiling, which will be performed in 9 NGS laboratories across the country. DNA and RNA sequencing will be performed with TruSight Oncology 500 (TSO500) in the participating Belgian labs. The variant interpretation and annotation will be discussed among molecular biologists from the participating laboratories to reach a consensus, after which their possible implications and treatment recommendations are discussed at the common national Molecular Tumor Board and shared with the treating physicians. Currently, the final phase of contracting is ongoing; recruitment is expected to start in March 2021.
  • Both BSMO comprehensive genomic profiling studies will generate valuable insights in the potential added value of this approach versus currently reimbursed sequencing across a wide range of solid tumors. Next to the potentially actionable molecular alterations, both trials also provide Tumor Mutational Burden which can guide your patients into immune-therapy based trials. The proposed treatment recommendations and enrolling trial opportunities take into account national availability of medical need and early access programs. They can provide additional treatment opportunities which would have remained undisclosed when only considering reimbursed diagnostics. Participation in Precision 1 is a requirement to be eligible for GeNeo or BALLETT. These projects are partnerships between the BSMO, Sciensano (www.sciensano.be) and industry. This tri-partnership academia-government-industry is key to have a sustained logistics and appropriate infrastructural framework implemented for optimal use of comprehensive genomic profiling in our daily practices. We believe that this partnership is exemplary for other countries. We want to thank the Precision Steering Committee, all participating investigators, collaborators and sponsors for all activities under the Precision umbrella.

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