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

Background

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).

Methods

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.

Results

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.

Conclusions

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.

Clinical trial identification

NCT03873103.

Editorial acknowledgement

Legal entity responsible for the study

Belgian Society of Medical Oncology (BSMO).

Funding

Roche, Fondation contre le Cancer, Kom op tegen Kanker.

Disclosure

P.G. Aftimos: Financial Interests, Personal, Advisory Board: Boehringer Ingelheim, Macrogenics, Roche, Novartis, Amcure, Servier, G1 Therapeutics, Radius, Deloitte, Menarini, Gilead, Novartis, Eisai, Lilly; Financial Interests, Personal, Invited Speaker: Synthon, Amgen; Financial Interests, Institutional, Research Grant: Roche. K. Punie: Financial Interests, Institutional, Advisory Board: AstraZeneca, Novartis, Roche, Vifor Pharma, Eli Lilly, Pierre Fabre, McCann Health, Roularta, Teva, Gilead Sciences, Pfizer, Gilead, MSD; Financial Interests, Institutional, Invited Speaker: Pfizer, Roche, Novartis, Eli Lilly, Mundi Pharma, MSD, Medscape, MSD; Financial Interests, Institutional, Other, Consultancy: Roche; Financial Interests, Personal, Other, Consultancy: Gilead, Novartis, MSD, Roche; Financial Interests, Personal, Invited Speaker: Sanofi, AstraZeneca, Exact Sciences, Focus Patient, Pfizer, Gilead Sciences; Financial Interests, Personal, Advisory Board: Seagen, AstraZeneca, Pfizer; Financial Interests, Personal, Ownership Interest: Need Inc.; Financial Interests, Institutional, Funding: Sanofi; Non-Financial Interests, Other, Committee member: ESMO Young Oncologists Committee; Non-Financial Interests, Leadership Role, Vice President: Belgian Society of Medical Oncology BSMO; Non-Financial Interests, Other, Committee Member: ESMO Resilience Task Force; Non-Financial Interests, Leadership Role: EORTC Breast Cancer Task Force Steering Committee Member; Non-Financial Interests, Institutional, Product Samples, Drug provision for academic research: Gilead Sciences; Non-Financial Interests, Advisory Role: Commission personalized medicine Federal Government Belgium; Non-Financial Interests, Advisory Role, External Scientific Advisor: European Medicine Agency. L. Decoster: Financial Interests, Institutional, Advisory Board: AstraZeneca, BMS, MSD; Financial Interests, Institutional, Invited Speaker: BMS, MSD, Roche, Servier, Sanofi; Financial Interests, Institutional, Research Grant, conduct of academic trial: Boehringer Ingelheim; Non-Financial Interests, Leadership Role, member of board: European Cancer Organisation; Non-Financial Interests, Leadership Role, Board member: International Society of Geriatric Oncology (SIOG). C. Van Marcke de Lummen: Financial Interests, Institutional, Advisory Board: Eli Lilly, Novartis, AstraZeneca; Non-Financial Interests, Member of Board of Directors: BSMO. A. Hebrant: Financial Interests, Personal, Full or part-time Employment: Sciensano. G. Raicevic: Financial Interests, Personal, Full or part-time Employment: Sciensano. E. Van Valckenborgh: Financial Interests, Personal, Full or part-time Employment: Sciensano. B. Maes: Financial Interests, Personal, Advisory Board: Servier, AstraZeneca, Illumina; Financial Interests, Personal, Invited Speaker: Pfizer, Illumina; Financial Interests, Institutional, Invited Speaker: Illumina, SeqOne; Non-Financial Interests, Principal Investigator: BSMO. J. Maetens: Financial Interests, Personal, Full or part-time Employment: Sciensano. J.J. Collignon: Financial Interests, Personal, Full or part-time Employment: Sciensano. S. Tejpar: Financial Interests, Institutional, Advisory Board: Roche, Boehringer Ingelheim, Bayer, Daiichi Sankyo; Financial Interests, Personal, Invited Speaker: Amgen, Merck Serono. J. Canon: Financial Interests, Institutional, Research Grant: Roche. S. Rottey: Financial Interests, Institutional, Advisory Board: Pfizer, Merck, Roche, Ipsen, BMS; Financial Interests, Institutional, Invited Speaker: Ipsen, BMS, Astellas; Financial Interests, Institutional, Research Grant: MSD, Roche, BMS; Non-Financial Interests, Principal Investigator, It is my main task in the hospital to attract and perform clinical trials in oncology phase I-III: all companies performing clinical trials in oncology in Europe. All other authors have declared no conflicts of interest.