Belgian trial to evaluate potential of genomic profiling of a patient’s cancer to guide personalized treatment options

The Belgian Approach for Local Laboratory Extensive Tumor Testing (BALLETT) study will recruit patients from 12 participating sites to be offered CGP from one of nine next-generation sequencing laboratories across Belgium.

Data from CGP will be used to determine the best therapeutic options for patients through access to targeted medicines with the aim of improving clinical outcomes in advanced cancer. The study will begin next month.

CGP uses next-generation sequencing (NGS) to analyze hundreds of genes and biomarkers in tissue and blood samples and detect those that are clinically relevant in driving cancer growth.

Illumina will provide its CGP panel, TruSight Oncology 500 (TSO500), as well as its NovaSeq 6000 and NextSeq sequencing platforms for the study.  

Dr Sven Schaffer, head of scientific affairs, Illumina, told BioPharma Reporter: “There is already compelling clinical data demonstrating that CGP helps to identify more cancer patients for highly effective, genomically-guided therapies, and that this can lead to better patient outcomes. ​

“What’s unique about this study being led by the BSMO across nine Belgian testing centers is that the utility of CGP will be demonstrated in a real-world setting compared with standard of care. This prospective, multi-centric approach will help us to gain new/additional insights in terms of feasibility, clinical utility and clinician acceptance.”​

Detecting genes and biomarkers ​

“Through this new study, we want to ensure that patients across Belgium can receive the right treatment for their particular cancer at the right time,” ​said Dr Sylvie Rottey, Chair BSMO.

Dr Brigitte Maes of the Jessa Hospital in Belgium, who is coordinator of the BALLETT study, said that, as part of Belgium’s broad approach to advancing precision medicine, the study will generate valuable insights into the value of CGP versus currently reimbursed sequencing approaches.

“For example, in addition to genetic mutations that drive cancer formation, CGP will also identify cancers driven by the tumor mutational burden (TMB) biomarker that can guide patients towards immunotherapy treatments. This means that the study will give access to additional treatments which may not have been considered through more traditional diagnostic testing," ​she said. 

Genomic data together with de-identified clinical data from the study will be used to populate a newly-established national genomic tumor database in Belgium, collated with oversight from the country's Scientific Institute for Public Health, Sciensano, designed to advance precision medicine and patients’ access to novel effective therapies.