181P GeNeo: Agnostic comprehensive genomic profiling versus limited panel organ-directed next-generation sequencing within the Belgian PRECISION initiative

Several targeted therapies are available through reimbursed organ-specific next-generation sequencing (NGS). Agnostic comprehensive genomic profiling (CGP) covering all classes of genomic alterations could improve access to molecularly-guided therapies (MGTs). PRECISION is an initiative launched by the Belgian Society of Medical Oncology (ESMO Open. 2022 Aug;7(4):100524). In the prospective GeNeo trial, CGP (FoundationOne CDx or Heme) was centrally done on tumor samples for patients with advanced solid tumors (NCT04641676). In parallel, organ-directed NGS panel testing was mandatory if reimbursed. Patients with no tissue sample were enrolled with a liquid biopsy. Results were discussed at a national molecular tumor board (MTB). Reasons for non-initiation of the recommended treatment were recorded. Clinical and genomic data are stored in the PRECISION database, with prospective follow-up up to 2 years. From October 2020 to April 2022, 1000 patients were enrolled at 13 sites. CGP results were available for 937 (843 tissue and 94 liquid biopsies) patients, out of which 918 were discussed at the MTB. The largest cohorts were breast (n=137), colorectal (n=128) and rare cancers (n=100). Turnaround-time from sample received to MTB recommendation was ≤ 28 days for 45% of cases and ≤ 37 days for 80%. 576 patients (63%) received at least one recommendation for CGP-based therapy. Cohorts with most treatment recommendations (>75% of cases) were bladder, biliary tract, skin and thyroid cancers. 72% of 469 patients who also had an organ-directed NGS test received at least one additional treatment recommendation based on CGP testing. Among the patients who received at least one MTB recommendation, 123 (21%) were treated accordingly. Reasons for non-compliance include patient ineligibility (26%), physician decision (23%) and treatment unavailability (22%). Follow-up continues. Tumor-agnostic CGP provides more treatment options to patients with advanced solid tumors when compared to organ-directed NGS panel testing. The national MTB provides recommendations within a clinically relevant timeframe and enhances the uptake of MGTs.