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World news – Positive study results should support the use of the test system in clinical studies with cancer drugs

New research suggests that an immunotherapy assay could determine PD-L1 status in a high percentage of cancer patients and guide personalized treatment choices.

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By Jane Byrne
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12-Apr-2021
– Last updated on
12-Apr-2021 at 12:28 GMT

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Liquid biopsy company ANGLE presents the results of two studies evaluating the effectiveness of two assays at the American Association for Cancer Research (AACR) virtual conference 2021, which will be held from April 10-15.

A poster, Mesenchymal Markers: The New Way to Detect Circulating Tumor Cells, reports on the performance of its new EMT (Epithelium-to-Mesenchymal Transition) assay to isolate and identify epithelial and mesenchymal circulating tumor cells (CTCs) in 47 breast cancer metastases (MBC) ) and 48 patients with non-small cell lung cancer (NSCLC).

In contrast to tissue biopsy, a liquid biopsy, in which CTCs are obtained from peripheral blood, enables routine, repeated testing and characterization of cancer for genetic (DNA), transcriptional purposes (RNA) and protein level, according to the assay developer.

“Most CTC isolation systems, including the market leader, b rely on epitope-dependent CTC detection using epithelial markers. However, it is known that tumor cells can undergo EMT, resulting in these clinically relevant cells being overlooked by epitope-dependent systems. « .

The company said its Parsortix system addresses this major limitation with its epitope-independent proprietary approach to detecting all phenotypes of cancer cells in the bloodstream.

 » This study highlights the importance of including mesenchymal markers in CTC Characterization as 25-38% of the CTCs captured by the Parsortix system expressed mesenchymal markers that would have been missed with an epithelial-only approach. In addition, 59% to 74% of CTCs had both epithelial and mesenchymal markers and therefore underwent EMT, while only 1-3% of CTCs were purely epithelial. “

It added that its EMT assay demonstrated high levels of analytical sensitivity (97-98%) and specificity (96-98%) in spike experiments and these results were confirmed in patient samples (96% specificity ).

Another poster, investigation of PD-L1 expression in circulating tumor cells isolated with the Parsortix system in metastatic lung and breast cancer patients, documents the results of the programmed death ligand 1 assay (PD-L1 ) of the company.

PD-L1 is a protein believed to play an important role in immuno-oncology and, when upregulated, enables many cancers to evade the host’s immune system. Immunotherapeutic agents known as PD-L1 inhibitors have shown excellent therapeutic results in several cancers in some patients. However, these drugs are expensive at around $ 170,000 per treatment and only work for about 30% of patients. ANGLE said this challenge highlights the need for companion diagnostics to enable targeted patient selection.

Measuring PD-L1 expression from CTCs offers the potential to identify, and most importantly, patients who may be responsive to such immunotherapeutic agents Monitoring patients receiving these therapies with a drug-specific goal, according to ANGLE.

The results of his study in 17 MBC and 18 metastatic NSCLC patients revealed CTCs in 70% and 55% of patients, respectively.

The company said no CTCs were found in 17 healthy volunteers, confirming high specificity. The PD-L1 assay allowed the final identification of PD-L1 positive and PD-L1 negative status in a high proportion of patients with CTCs (72% of MBC and 60% of NSCLC), with the remaining patients being a mixture PD-L1 had positive and PD-L1 negative CTCs, confirming it. The research lays the groundwork for further refinement of the assay to enable dynamic PD-L1 monitoring in patients during their treatment and follow-up, said the assay manufacturer.

« Future drug trials with immune checkpoint inhibitors will be targeted for the launch of the Parsortix PD-L1 assay. ANGLE is developing a pharmaceutical service feature that will enable these types of test samples for several such biomarkers on a commercial scale « said Company Founder and CEO Andrew Newland.

ANGLE recently opened clinical services laboratories in the UK and US opens and explains how it is in advanced discussions with potential customers about the use of the Parsortix system in clinical trials with cancer drugs. It is emphasized that there are over 2,000 interventional PD-L1 / PD-1 studies with over 300,000 patients registered on clinicaltrials.gov that could represent potential targets for the pharmaceutical services business. « We look forward to updating the market with the first contracts in due course. » .

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