2316P - Integrating comprehensive cancer genome profiling into clinical practice in an Italian referral center: Results of the first year of the fpg500 programme

Background

The comprehensive cancer genome profiling (CGP) programme (ID: FPG500, IRB approval 3837) is an interventional monocentric study extending somatic genomic assessment to 523 genes in patients with advanced solid tumors.

Methods

The study enrolls cancer patients whose molecular characterization should be warranted according to national and international guidelines. The primary endpoints were the feasibility of the programme (turn around time-TAT and samples failure rate) and the rate of actionable alterations identified. Secondary endpoints included the number of reports sent to the institutional molecular tumor board (MTB), the rate of patients’ enrollment in biomarker-driven clinical trial and the identification of potentially germline variants.

Results

From January 2022 to December 2022, 1367 patients were enrolled, including non-small-cell lung cancer (263), ovarian (446), endometrium (246), colorectal (191), pancreatic (83), cholangiocarcinoma (28), prostate (48), melanoma (45), gastrointestinal stromal tumor (GIST) (3), thyroid (7) and breast cancer (7). The overall failure rate was 5%. CGP sequencing data were available for 1162 (85%) patients, while 205 (15%) were addressed to targeted panels. By the end of 2022 an improving average TAT of genomic profiling was reported (25 days), despite an increasing number of monthly analysed samples (mean 114). Genomic alterations according to OncoKB annotation were identified in 96% patients. Potentially pathogenic/likely pathogenic germline variants were identified in 29% of patients. Overall, 6% of cases were sent to MTB.

Conclusions

FPG500 represents the largest prospective European single institution genomic profiling series and highlights the utility of CGP for identifying therapeutic targets in selected cancer patients, concomitant alterations for further predictive and prognostic characterization and germline implications.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

C. Nero: Other, Personal, Other, Travel Support: Illumina. D. Lorusso: Financial Interests, Personal, Advisory Board, Participation in Advisory Boards and Invited Speaker: GSK, Clovis Oncology, PharmaMar; Financial Interests, Personal, Advisory Board, Participation in Advisory Boards and Invited Speakers: AstraZeneca, MSD; Financial Interests, Personal, Other, Consultancy: PharmaMar, AstraZeneca, Clovis Oncology, GSK, MSD, Immunogen, Genmab, Seagen, Novartis; Financial Interests, Personal, Advisory Board, Invited member of advisory board and invited speaker: Seagen, Immunogen, Genmab; Financial Interests, Personal, Advisory Board, Invited member of advisory board: Oncoinvest, Corcept, Sutro; Financial Interests, Institutional, Funding, Grant for founding academic trials: MSD, Clovis Oncology, GSK, PharmaMar; Financial Interests, Institutional, Coordinating PI, ENGOT trial with institutional support for coordination: Clovis Oncology; Financial Interests, Institutional, Coordinating PI, ENGOT trial with Institutional Support for coordination: Genmab, MSD; Financial Interests, Institutional, Funding, Clinical trial/contracted research: AstraZeneca, Clovis Oncology, GSK, MSD, Seagen; Financial Interests, Institutional, Funding, Clinical trials/contracted research: Genmab, Immunogen, Incyte, Novartis, Roche; Non-Financial Interests, Principal Investigator, PI of several trials, no compensation received: GSK; Non-Financial Interests, Principal Investigator, PI of several trials. No personal compensation received: AstraZeneca, Genmab; Non-Financial Interests, Principal Investigator, PI in several trials. No personal compensation received: MSD; Non-Financial Interests, Principal Investigator, PI of clinical trial. No personal compensation received: immunogen, Clovis Oncology, Roche, Incyte; Non-Financial Interests, Principal Investigator, PI of several trials, no personal compensation received: Novartis; Non-Financial Interests, Principal Investigator, PI of clinical trial, no personal compensation received: Seagen; Non-Financial Interests, Principal Investigator, PI of clinical trials, no personal compensation received: PharmaMar; Non-Financial Interests, Member, Board of Directors: GCIG; Other, Grants for traveling: AstraZeneca, Clovis Oncology, GSK. N. Normanno: Financial Interests, Personal, Invited Speaker: MSD, Illumina, Merck, ThermoFisher, Eli Lilly; Financial Interests, Personal, Advisory Board: Amgen, Bayer, Biocartis, Incyte, Roche, AstraZeneca, Novartis; Financial Interests, Institutional, Research Grant: Merck, ThermoFisher, QIAGEN, Roche, AstraZeneca, Biocartis, Illumina, Incyte, Blueprint; Non-Financial Interests, Leadership Role, President: International Quality Network for Pathology (IQN Path), Italian Cancer Society (SIC). E. Bria: Financial Interests, Personal, Advisory Board: AZ, Roche, BMS, MSD, Eli Lilly, Amgen, Pfizer, Novartis; Financial Interests, Personal, Invited Speaker: AZ, Roche, BMS, MSD, Eli Lilly, Pfizer, Novartis; Financial Interests, Institutional, Research Grant: AZ, Roche. G. Tortora: Financial Interests, Personal, Advisory Board: Novartis, BMS. G. Scambia: Financial Interests, Personal, Invited Speaker, Speaker: Johnson & Johnson, Baxter Healthcare, GSK, Intuitive Surgical Inc., AstraZeneca & MSD, Olympus Europa; Financial Interests, Personal, Advisory Board, Trainer: Covidien AG (Medtronic company); Financial Interests, Institutional, Coordinating PI, ‘IsoMSLN’ in Ovarian Cancer and Malignant Pleural Mesothelioma: Kiromic; Financial Interests, Institutional, Coordinating PI, Roll-over study for patients who have completed a previous cancer study with olaparib and who the investigator believes can benefit from continued treatment - ROSY-O: AstraZeneca; Financial Interests, Institutional, Coordinating PI, CATCH-R: Roll-over study to provide continuous access to clinical therapy with rucaparib: Clovis Oncology; Financial Interests, Institutional, Coordinating PI, Phase III, multicenter, placebo-controlled clinical study comparing chemo-immunotherapy (paclitaxel-carboplatin-oregovomab) versus chemotherapy (paclitaxel-carboplatin-placebo) in patients with advanced epithelial ovarian, tubal cancer of fallopian or peritoneal (FLORA-5): Oncoquest Pharmaceuticals Inc.; Financial Interests, Institutional, Coordinating PI, phase IIb randomized, open-label, active comparator, parallel-group, multicenter study designed to evaluate the efficacy and safety of three different doses of the P2X3 receptor antagonist (BAY 1817080) versus placebo and Elagolix 150 mg in women with symptomatic endometriosis: Bayer AG; Financial Interests, Institutional, Coordinating PI, Usability of ITE transducers for sending electric fields for tumor treatment (TTFields): Novocure Ltd.; Financial Interests, Institutional, Coordinating PI, Phase III, multicentre, open-label extension trial to evaluate long-term safety and efficacy in patients with advanced cancers currently undergoing treatment or in follow-up in a pembrolizumab trial: Merck. All other authors have declared no conflicts of interest.