Associations between early changes in circulating tumor DNA (ctDNA) and outcomes across randomized trials: Insights from the ctMoniTR project.

Hillary S Andrews¹, Nevine Zariffa², Emily M Goren³, Katherine K Nishimura³, Adam Rosenthal³, Abde Abukhdeir⁴, Grace Collins¹, Maya Dajee⁵, Yu Deng⁶, Shibing Deng⁷, Joe Ensor⁸, Carin R Espenschied⁹, David Fabrizio¹⁰, Minakshi Guha¹¹, Darren Hodgson¹², Dilafruz Juraeva¹³, Nicole Kräemer¹⁴, German G Leparc¹⁴, Elena Levi-D'Ancona¹, Minetta Liu⁸, Diana Merino Vega⁴, Bernat Navarro-Serer¹, Gary A Pestano¹⁵, Nadia Solovieff⁵, Sriram Sridhar¹⁶, Mark D Stewart¹, James P Sullivan⁶, Stephan Wojciekowski¹⁴, Antje Hoering³, Jeff D Allen¹

¹Friends of Cancer Research, 1800 M Street NW, Suite 1050S, Washington, DC, USA.

²NMD Group LLC, Bala Cynwyd, PA, USA.

³Cancer Research and Biostatistics (CRAB), Seattle, WA, USA.

⁴AstraZeneca, Gaithersburg, MD, USA.

⁵Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.

⁶Genentech Inc, South San Francisco, CA, USA.

⁷Pfizer, Inc., New York, NY, USA.

⁸Natera, Inc., Austin, TX, USA.

⁹Guardant Health, Inc., Redwood City, CA, USA.

¹⁰Foundation Medicine, Inc., Cambridge, MA, USA.

¹¹Takeda Pharmaceuticals, Cambridge, MA, USA.

¹²AstraZeneca, Cambridge, United Kingdom.

¹³The Healthcare Business of Merck KGaA, Darmstadt, Germany.

¹⁴Boehringer Ingelheim International GmbH, Biberach, Germany.

¹⁵Biodesix Inc, Louisville, CO, USA.

¹⁶Genmab US, Inc., Plainsboro, NJ, USA.

PubMed PMC DOI PDF

Abstract

BACKGROUND: Circulating tumor DNA (ctDNA) dynamics have emerged as a promising biomarker of treatment response in oncology drug development. Early decreases in ctDNA levels after treatment initiation are associated with improved long-term outcomes in patients with advanced cancer. To be considered for regulatory decision-making, patient-level meta-analyses evaluating individual-(I-) and trial-(T-)…

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