5:27 PM
Apr 12, 2019
 |  BioCentury  |  Tools & Techniques

ctDNA inches toward new applications

How ctDNA could move into applications beyond patient stratification

After establishing itself as a key tool for tumor profiling and patient stratification, circulating tumor DNA is now beginning to make the move into monitoring response to therapy, where it promises an early read of efficacy that could cut clinical timelines and costs.

Getting from here to there will require generation of prospective validation data across several cancer types and therapies, plus standardization of assays to measure ctDNA. Several companies have started gathering the data and forming the collaborations needed to make this happen.

ctDNA assays stand to read out drug response within weeks, instead of the months patients normally wait to get an image-based readout. These tests detect cell-free DNA that has been shed from tumors into blood and constitute one form of liquid biopsy.

Adoption of ctDNA assays would not only speed up clinical trials, it could spare patients months of exposure to a drug that isn’t working and give them a chance to move on to a different treatment sooner.

The method’s speed would be a boon for adaptive clinical trials, where one of the major aims is quick reassignment of non-responsive patients to another study arm.

Companies large and small are already using ctDNA to profile tumors and stratify patients for trials. One assay has been approved by FDA, the Cobas EGFR Mutation Test v2 from Roche and AstraZeneca plc, which detects EGFR mutations in lung cancer patients.

“For advanced cancer, ctDNA is here and now, not just for blood profiling where tissue biopsies fall short, but as a first profiling methodology.”

Amirali Talasaz, Guardant Health

“For advanced cancer, ctDNA is here and now, not just for blood profiling where tissue biopsies fall short, but as a first profiling methodology,” Amirali Talasaz, president of COO of Guardant Health Inc., told BioCentury. Guardant is developing the Guardant360 liquid biopsy to detect mutations in non-small cell lung cancer (NSCLC).

Three biopharma companies interviewed by BioCentury all said they’re using ctDNA for monitoring drug response to support clinical development programs.

But they noted much work remains to be done, and there’s no consensus yet on which aspects of the DNA to monitor, such as the number of mutations or their evolution over time.

For the technology to go mainstream and ultimately be used to create surrogate endpoints, they think industry needs to come together to collect validation data and agree on standards.

“The areas of drug monitoring, minimal residual disease detection and early diagnostics still need development, and it will take a number of years before they move past internal drug development, but we see them as being transformative,” said Carl Barrett, VP of oncology translational sciences at AstraZeneca.

Need for speed

In addition to being cheaper and...

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