Post-ASCO Summary: ctDNA as a patient selection and early efficacy marker in drug development

In recent months, a wealth of data has emerged in support of using ctDNA to identify patient populations who may benefit from additional treatment and to provide early efficacy signals within weeks of beginning treatment.

Our expert speakers will discuss the latest data from ASCO 2023 and other recent publications and congresses. This will be followed by a panel discussion on the future directions and implications for drug development and clinical trial design in this rapidly evolving space.

Findings presented will span treatment settings and tumor types, including:

Colorectal cancer:
  • Updated analyses from the prospective CIRCULATE-Japan study demonstrating that post-op ctDNA status and clearance is prognostic of outcomes (Oki et al., ASCO 2023; inclusive of 2,000+ patients) and can be predictive of adjuvant chemotherapy benefit (Kotani et al., Nature Medicine 2023)
  • ctDNA surveillance identified patients with molecular residual disease (MRD), in the absence of radiologically evident disease, for enrollment onto MRD-focused clinical trials (Dasari et al., ASCO 2023)
  • Real-world analysis of 13,000+ patients with stage I-III colorectal cancer identified differentiating genomic characteristics of early vs. late onset disease, with the potential to guide personalization of therapies (Lander et al., ASCO 2023)
Breast cancer:
  • Early ctDNA dynamics during neoadjuvant chemotherapy predicted clinical outcomes in high-risk early-stage HER2-negative breast cancers (Magbanua et al, Cancer Cell 2023, George et al., ESMO Breast 2023)
  • Early stage TNBC patients who were ctDNA-positive post-op did not clear on capecitabine, suggesting a need for novel agents in the adjuvant setting (Gupta et al., ESMO Breast 2023)
Lung cancer:
  • Early ctDNA dynamics, 6-9 weeks following treatment start, correlated with survival benefit from immunotherapy (Vokes et al., ASCO 2023) and immunotherapy + chemotherapy (Awad et al., Cancer Cell 2022)
  • Post-operative and longitudinal ctDNA status were strongly prognostic of disease recurrence in stage I-II NSCLC, across subtypes (Dinerman et al., AATS 2023)
Implications for drug development:
  • Patients who have persistent or increasing levels of ctDNA may benefit from treatment with investigational therapies; real-world patients can be matched to clinical trials which may accelerate ctDNA-guided trial enrollment
  • Assessment of early changes in levels of ctDNA, within weeks of beginning therapy, could support accelerated decision-making
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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.

Angel Rodriguez

Angel Rodriguez

Oncology Medical Director, Natera

Angel Augusto Rodriguez, MD, is a board-certified medical oncologist who specializes in breast medical oncology and conducted clinical research with circulating tumor DNA. Before joining Natera, Dr. Rodriguez practiced at Austin Cancer Centers and Houston Methodist Cancer Center where he was Director of the Clinical Trials Office and the Triple Negative Breast Cancer Clinic. While at Houston Methodist he was the principal investigator of clinical trials and conducted clinical research with circulating tumor DNA.

Michael Krainock

Michael Krainock

Oncology Associate Medical Director, Natera

Michael Krainock, MD, PhD, is a Medical Director in Thoracic Oncology at Natera. Michael is a physician-scientist by training with experience in biotechnology and life sciences innovation. After completing his medical degree at the University of Nevada, Michael went on to earn a PhD at the University of Southern California, studying the epigenetic regulation of epithelial-to-mesenchymal transformation. Michael completed residency training in general surgery at Loma Linda University Medical Center and fellowship training in cardiothoracic surgery at the University of Pittsburgh Medical Center. Michael has also received an MBA from the Gies College of Business - University of Illinois.

John Simmons

John Simmons

Global VP Biopharma, Natera

John Simmons, PhD 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 PhD in Tumor Biology from Georgetown University.