Abstract 1268P
Background
The comprehensive genomic profile by next generation sequencing (NGS) of circulating tumour DNA (ctDNA) can identify a wide spectrum of genomic alterations in non-small cell lung cancer (NSCLC). We aim to assess the real-time clinical utility of ctDNA-NGS for guiding therapies.
Methods
Prospective study of consecutive patients (pts) with newly diagnosed advanced NSCLC in our center, regardless of smoking status, enrolled since Jan/21. ctDNA liquid biopsy (LB) was analysed using InVisionFirst®-Lung. We evaluated the detection of any genomic alterations (GAs), the rate of informative results (any driver alterations guiding or not to targeted therapy: EGFR/ALK/ROS1/BRAF/MET/KRASG12C/HER2/RET/NTRK1) and the clinical utility (considering turnaround time, sensitivity and tissue/blood concordance). We reported the GAs based on ESCAT tiers. Targeted tissue NGS was also performed.
Results
In 60 pts planned to be enrolled, we report the preliminary data from the first 31. A total of 61% were male, with median age of 62; 71% were current/former smokers. Adenocarcinoma was the most frequent histology (84%); 68% had > 2 metastatic sites.The median turnaround time of LB was 8 days (range: 6-12 days). Median time of tissue molecular report was 19 days (11-30); LB anticipated a median of 11 days the tissue report. At least 1 GAs was found in 88% of pts and 68% had informative results. 15 (45%) had one GAs included in ESCAT tier I and II: 33% were classified as tier I (5/31; 4 EGFR, 1 BRAF V600E) and 66% as tier II (10/31; 7 KRAS G12C, 1 MET amplification; 2 HER2 amplification). Of these pts, 4 were treated with approved targeted therapy and the median time from report to treatment was 7 days (6-10). In the 17 cases (55%) with tissue NGS at diagnosis, the concordance for any of the main driver GAs detected was 94%. In 11 pts (35%), tissue was insufficient for molecular assessment. In this population we had informative results in 55%: 1 EGFR, 3 KRAS G12C, 2 HER2 amplifications.
Conclusions
Real-time ctDNA is feasible and clinically informative in unselected pts with newly diagnosed advanced NSCLC. Preliminary data showed that LB could support the treatment selection in 68% of pts. This study is still ongoing; final data and outcomes based on ctDNA will be presented at ESMO Congress.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Hospital Clinic Barcelona.
Funding
Has not received any funding.
Disclosure
C. Pipinikas: Financial Interests, Institutional, Full or part-time Employment: Inivata Ltd. R. Reyes: Financial Interests, Personal, Ownership Interest: Roche; Financial Interests, Personal, Ownership Interest: BMS. E. Auclin: Financial Interests, Personal, Other, Travel: Mundipharma; Financial Interests, Personal, Ownership Interest: Sanofi. K. Howarth: Financial Interests, Personal and Institutional, Full or part-time Employment: Inivata Ltd. A. Prat: Financial Interests, Personal, Ownership Interest: Novartis; Financial Interests, Personal, Ownership Interest: Pfizer; Financial Interests, Personal, Ownership Interest: Roche; Financial Interests, Personal, Ownership Interest: MSD; Financial Interests, Personal, Ownership Interest: Lilly; Financial Interests, Personal, Ownership Interest: Daiichi Sankyo; Financial Interests, Personal, Funding: Roche; Financial Interests, Personal, Funding: Novartis; Financial Interests, Personal, Advisory Role: NanoString Technologies; Financial Interests, Personal, Advisory Role: Amgen; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Advisory Role: Pfizer; Financial Interests, Personal, Advisory Role: Bristol Myers Squibb. N. Viñolas: Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: Boehringer Ingelheim; Financial Interests, Personal, Funding: BMS; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Ownership Interest: Roche; Financial Interests, Personal, Ownership Interest: Boehringer Ingelheim; Financial Interests, Personal, Ownership Interest: AstraZeneca; Financial Interests, Personal, Ownership Interest: Lilly. L. Mezquita: Financial Interests, Personal, Invited Speaker: Bristol; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker: Tecnofarma; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: Takeda; Financial Interests, Personal, Research Grant: Boehringer Ingelheim; Financial Interests, Personal, Research Grant: Bristol Myers Squibb; Financial Interests, Boehringer Ingelheim, Other, Travel: Bristol Myers Squibb; Financial Interests, Personal, Other, Travel: Roche; Financial Interests, Personal, Other, international training: AstraZeneca. All other authors have declared no conflicts of interest.