Frequencies and expression levels of programmed death ligand 1 (PD-L1) in circulating tumor RNA (ctRNA) in various cancer types.

  • Liquid Genomics, Inc.
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... 105 Also, circulating free RNA (cfRNA) can be used for the measurement of RNA transcripts of fusion genes (SLIT and NTRK like family member 1 [NTRK], ALK, ROS1, and ret proto-oncogene [RET]) and MET-14 splicing variant by rt-PCR. [106][107][108] Programmed cell death ligand 1in blood in NSCLC is being explored as tool to predict response to immunotherapy. Raez et al. have found a strong correlation between clinical responses assessed by computed tomographic scans with changes in plasma levels of cfRNA in patients with NSCLC, some of these were documented weeks before imaging was performed. ...
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The isolation of circulating cell-free tumoral DNA (ctDNA) in plasma and its subsequent molecular analysis is a powerful tool that can help improve clinical outcomes across multiple cancer types, including non-small cell lung cancer (NSCLC). Assays of this nature that utilize blood as opposed to tumor samples are frequently referred to as liquid biopsies. An increasing number of new platforms have been recently developed that improve not only the fidelity of the molecular analysis of the liquid biopsy but also the number of tests performed on a single specimen. ctDNA assays for detection of both epidermal growth factor receptor (EGFR) sensitizing and resistance mutations have already entered clinical practice and many other molecular tests - such as resistance mutations for ALK rearrangements - are likely to do so in the near future. Due to an abundance of new evidence, an appraisal was warranted to review strengths and weaknesses, to describe what is already in clinical practice and what has yet to be implemented, and to highlight areas in need of further investigation. A multidisciplinary panel of experts in the field of thoracic oncology with interest and expertise in liquid biopsy and molecular pathology, was convened by the International Association for the Study of Lung Cancer (IASLC) to evaluate current available evidence with the aim of producing a set of recommendations for the use of liquid biopsy for molecular analysis in in guiding the clinical management of advanced NSCLC patients as well as identifying unmet needs.
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The programmed death-1/programmed death ligand-1 (PD-1/PD-L1) immune checkpoint represents a critical target for novel cancer immunotherapies. Antibody-based PD-1/PD-L1 inhibitors, which overcome tumor resistance to T-cell anticancer activity, have proven capable of generating durable responses and extending overall survival in patients with non-small cell lung cancer (NSCLC) or other cancers. However, their remarkable efficacy is highly selective, and limited to patients with specific but incompletely understood disease characteristics. Factors governing PD-1/PD-L1 inhibitor susceptibility and resistance are likely multifold, and are a subject of intense research. Not only are anti-PD-1/PD-L1 immunotherapies extremely expensive, but they could also have serious side effects. Moreover, ineffective immunotherapy could lead to patients’ rapid deterioration, resulting in loss of opportunity to pursue any further therapy. Accurate patient selection is therefore imperative. The current diagnostic method to predict anti-PD-1/PD-L1 immunotherapy responsiveness utilizes immunohistochemistry assays that detect the expression level of the PD-L1 protein in tumor tissue. However, the development pathway for the antibodies, methods, and interpretive standards is inconsistent. Diagnostic thresholds vary by tumor type and stage, prior therapeutic history, and the specific anti-PD-1/PD-L1 immunotherapy agent in use. With no universal reference standard, diagnostic interpretation can be inconsistent and subjective. To address the current limitations of PD-L1 testing, several companies are working toward developing assays capable of detecting variable PD-L1 expression levels in peripheral blood, using a number of complementary approaches. While well grounded in theory, practical development of such tests has presented challenges of its own. This article reviews the state of the art in PD-L1 diagnostic testing by immunohistochemistry, summarizes different approaches to developing a blood-based assay, and describes the design and objectives of a new clinical study designed to validate a plasma-based mRNA assay for guiding patient selection for anti-PD-1/PD-L1 immunotherapy.
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