Imi'S Cancer-Id: Implications Of Liquid Biopsy Technology Standardization For Its Clinical Use

Liquid biopsies offer the opportunity to improve the diagnosis and timely adaption of therapy options to the progression and heterogeneity of cancer. The CANCER-ID (www.cancer-id.eu) consortium was established in early 2015 as part of the Innovative Medicines Initiative (IMI) and has currently 37 partners from 14 countries, including the USA and Singapore. The goal of the CANCER-ID program is to foster implementation of liquid biopsy technologies in multicenter clinical studies and the potential regulatory approval of devices or protocols in the field. Within the project best practice protocols for using technologies aiming at the enrichment, isolation and analysis of Circulating Tumor Cells (CTCs), circulating free tumor DNA (ctDNA) and microRNAs (miRNAs) are being developed and benchmarking data for the performance of different technologies are collected. To this end defined standards for the different biomarker classes are crucial and their introduction and design is being supported by CANCER-ID. Another integral part of our work is the development of integrated workflows from patient sample collection, pre-analytical sample handling, sample and bioinformatics analyses down to the actionable information guiding patient selection and personalized treatment. CANCER-ID partners are currently planning clinical studies to assess the clinical utility of analyzing PD-L1 expression on CTCs in their core indications Non-Small Cell Lung Cancer (NSCLC) and metastatic breast cancer. While the benefit of immune checkpoint inhibition has been impressively demonstrated in NSCLC, most advanced breast cancer patients do not benefit from targeting PD-1 with the exception of the triple-negative disease type. The liquid biopsy workflows established by the CANCER-ID consortium will be used to correlate CTC PD-L1 expression in patients treated with PD-1 blocking antibodies with clinical response and in parallel perform mutational load analysis in blood. The aim will be to attempt to develop a liquid biopsy-based rationale for patient selection guiding effective immune checkpoint therapies. The study plan and current status of this multicenter effort will be presented. This work is supported by IMI JU u0026 EFPIA (grand no. 115749, CANCER-ID). Samples from patients and healthy volunteers, respectively, were collected under signed informed consent. Citation Format: Klaus Pantel, Leon W. Terstappen, Barbara Baggiani, Thomas Krahn, Catherine Panabieres, Evi Lianidou, Bjorn Naume, Francoise Farace, Thomas Schlange. IMI9s CANCER-ID: Implications of liquid biopsy technology standardization for its clinical use [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2018; 2018 Apr 14-18; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2018;78(13 Suppl):Abstract nr 1579.