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NHS to use genetic analysis to match more cancer patients to clinical trials

In a significant breakthrough, thousands of NHS cancer patients, who have exhausted all other options, are being offered liquid biopsy blood tests to match them to personalised medicines.

The groundbreaking genetic analysis gives patients a better chance of successfully trying new treatments. A pioneering scheme piloted at the Christie NHS Foundation Trust in Manchester proved so successful it is being rolled out across the UK, The Guardian reports.

The development is a major one. Cancer patients who have run out of options but are still reasonably well have been able to access clinical trials based on their cancer type – breast cancer, for example – for decades. However, many of these trials do not target the DNA profile of the patientʼs tumour.

Now those patients are being offered personalised drugs via the nationwide initiative. By understanding the genetic faults in a patientʼs cancer from a simple blood test, doctors can match more patients to specific clinical trials – with the hope of saving or extending lives.

The TARGET National initiative is being funded by the Christie charity and the Sir Bobby Robson Foundation in Newcastle, and is recruiting thousands of cancer patients via 18 cancer centres in England, Scotland, Wales and Northern Ireland.

The new approach is essentially a match-making service for patients and clinical trials, adds The Guardian. The faster that patients can try new drugs that might help them, the better chance of life-changing results. The pilot study found patients accessing new drugs this way were more likely to see their tumours shrink. The results also suggested that a wider pool of patients and clinical trials would further increase the chances of success.

“The learnings from our original TARGET study in Manchester were that genetic testing needs to be done on a large scale to identify rare genetic mutations, and that broader access to medicines, through clinical trials across the country rather than just one site, are required,” said Dr Matthew Krebs, a consultant oncologist at the Christie who is leading TARGET National.

“This study will allow thousands of cancer patients in the UK to access genetic testing via a liquid biopsy. This will enable us to identify rare genetic mutations that in some patients could mean access to life-changing experimental medicines that can provide great treatment responses, where there are otherwise limited or no other treatment options available.”

The scheme is open to cancer patients with solid tumours who have exhausted all other options and are considered by their oncologists to be suitable for early-phase experimental trials. Researchers analyse the genetic characteristics of a patientʼs cancer from a blood sample and look for faulty genes that may inform that personʼs suitability to receive an experimental treatment.

The new initiative uses a state-of-the art blood test made by Roche that spots genetic faults in the cancer. Because tiny amounts of DNA leak from tumours into the blood stream, a simple blood sample is all that is needed to find the tumourʼs genetic code.

“We canʼt guarantee that we will find a fault in the genetic code of every cancer patient we recruit, or that if we do, there will be a suitable drug trial for them,” said Krebs. “However, as we learn more about the genetics of cancer in this study, it will help doctors and scientists develop new treatments to help people in the future.

“Ultimately, we hope liquid biopsy testing will be adopted into routine NHS care but we need studies like this to show the benefit of the test on a large scale and provide the evidence that patients can benefit from being matched to targeted medicines on the basis of the blood test.”

Original TARGET STUDY details

Utility of ctDNA to support patient selection for early phase clinical trials: the TARGET study

Dominic G. Rothwell, Mahmood Ayub, Matthew G. Krebs et al.

Published in Nature Medicine on 22 April 2019

Next-generation sequencing (NGS) of circulating tumour DNA (ctDNA) supports blood-based genomic profiling but is not yet routinely implemented in the setting of a phase I trials clinic. TARGET is a molecular profiling programME with the primary aim to match patients with a broad range of advanced cancers to early phase clinical trials on the basis of analysis of both somatic mutations and copy number alterations (CNA) across a 641 cancer-associated-gene panel in a single ctDNA assay. For the first 100 TARGET patients, ctDNA data showed good concordance with matched tumor and results were turned round within a clinically acceptable timeframe for Molecular Tumour Board (MTB) review. When a 2.5% variant allele frequency (VAF) threshold was applied, actionable mutations were identified in 41 of 100 patients, and 11 of these patients received a matched therapy.
These data support the application of ctDNA in this early phase trial setting where broad genomic profiling of contemporaneous tumour material enhances patient stratification to novel therapies and provides a practical template for bringing routinely applied blood-based analyses to the clinic.


The Guardian article – NHS cancer patients to get pioneering genetic test to find best treatments (Open access)


Nature Medicine abstract – Utility of ctDNA to support patient selection for early phase clinical trials: the TARGET study (Open access)


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Too many experimental drugs, too may trials, too few patients


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