New data: ctDNA as a prognostic and predictive biomarker in early-stage gastrointestinal cancers

Early stage drug development can require significant time and resource investment, especially when involving large all-comer trials and long follow-up to assess outcomes. Circulating tumor DNA (ctDNA) has emerged as a sensitive and specific biomarker to identify patients with gastrointestinal malignancies who are at high risk of relapse and most in need of additional treatment.

Our expert speakers will discuss the latest data from 2023 and 2022 supporting the use of ctDNA in clinical practice and drug development, including:

  • A prospective study of >1,000 patients with high-risk Stage II-IV colorectal cancer demonstrating that ctDNA can predict adjuvant chemotherapy benefit, and that a sizeable portion of patients with detectable ctDNA relapse despite receiving chemotherapy (Kotani et al., Nature Medicine 2023).
  • Retrospective analyses of real-world gastroesophageal patients demonstrating that:
    • Post-operative detection of ctDNA associated with shorter recurrence free survival (Huffman et al., JCO-PO 2022).
    • Post-operative detection of ctDNA identified patients with elevated recurrence risk even in the subgroup of patients with a favorable pathologic response (Lander et al., ASCO GI 2023)

This will be followed by a panel discussion on the implications and future directions for patient management and drug development.

What does this new data mean for drug development?
  • Patients who have persistent or increasing levels of ctDNA may be at high risk of relapse without additional treatment. This population has a high clinical need for treatment with novel investigational agents
  • Patients with undetectable ctDNA or clear ctDNA during or post-treatment have been shown to have superior DFS and OS. In all comer trial designs, these patients may dilute efficacy signals and be subject to additional toxicity with incremental survival benefit
  • Early changes in levels of ctDNA, within weeks of beginning systemic therapy, are prognostic of longer-term outcomes to support accelerated decision-making
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Michael Gibson

Michael Gibson

Associate Professor of Medicine, Vanderbilt

Dr. Michael Gibson, MD, Ph.D., is an Associate Professor of Medicine and Director of Translational Research for Head and Neck Oncology at Vanderbilt. He leads local and national therapeutic trials for aero-digestive cancers, all with translational laboratory components. His laboratory experiences at the National Cancer Institute and National Institute of Environmental Health Sciences led to a number of publications regarding hormone receptor biology and DNA repair, which led to his translational research focus. The overall goals of his research efforts are to bring novel therapeutics to the treatment of aero-digestive cancers based on rational pre- clinical investigation and in the setting of a focus on patient safety and outcomes. Dr. Gibson obtained his MD from Johns Hopkins, after which he completed an Osler Medical Residency and Medical Oncology Fellowship at Johns Hopkins Hospital while concurrently earning a PhD in Clinical Investigation from the Johns Hopkins Bloomberg School of Public Health.

Adham Jurdi

Adham Jurdi

Oncology Medical Director, Natera

Adham Jurdi, MD, is a Board-certified Medical Oncologist who specializes in gastrointestinal malignancies. Prior to joining Natera, Dr. Jurdi practiced at Austin Cancer Center, SUNY Upstate Medical University and the Syracuse VAMC. Throughout his clinical career, he was involved in GI oncology and precision medicine research.

John Simmons

John Simmons

Global VP Biopharma, Natera

John Simmons, Ph.D., currently leads oncology biopharma partnerships at Natera. Before joining Natera, John completed his postdoctoral fellowship at the National Cancer Institute (NCI) and served as Vice President of Translational Medicine at Personal Genome Diagnostics (PGDx). He received his Ph.D. in Tumor Biology from Georgetown University.

Kari Abitbol

Kari Abitbol

Director, Client Success, Endpoints News

As head of the client success team at Endpoints News, Kari oversees campaign delivery for all advertising and client-directed webinars.