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Circulating tumor DNA: Opportunities and challenges for pharmacometric approaches

Affiliation
Roche Pharma Research and Early Development ,Roche Innovation Center Basel ,F. Hoffman-La Roche Ltd ,Basel ,Switzerland
Ribba, Benjamin;
Affiliation
Roche Pharma Research and Early Development ,Roche Innovation Center Basel ,F. Hoffman-La Roche Ltd ,Basel ,Switzerland
Roller, Andreas;
Affiliation
Roche Pharma Research and Early Development ,Roche Innovation Center Basel ,F. Hoffman-La Roche Ltd ,Basel ,Switzerland
Helms, Hans-Joachim;
Affiliation
Roche Pharma Research and Early Development ,Roche Innovation Center Basel ,F. Hoffman-La Roche Ltd ,Basel ,Switzerland
Stern, Martin;
Affiliation
Roche Pharma Research and Early Development ,Roche Innovation Center Basel ,F. Hoffman-La Roche Ltd ,Basel ,Switzerland
Bleul, Conrad

To support further development of model-informed drug development approaches leveraging circulating tumor DNA (ctDNA), we performed an exploratory analysis of the relationships between treatment-induced changes to ctDNA levels, clinical response and tumor size dynamics in patients with cancer treated with checkpoint inhibitors and targeted therapies. This analysis highlights opportunities for pharmacometrics approaches such as for optimizing sampling design strategies. It also highlights challenges related to the nature of the data and associated variability overall emphasizing the importance of mechanistic modeling studies of the underlying biology of ctDNA processes such as shedding, release and clearance and their relationships with tumor size dynamic and treatment effects.

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License Holder: Copyright © 2023 Ribba, Roller, Helms, Stern and Bleul.

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