Circulating tumor DNA as a predictive biomarker for immunotherapy response: from clinical trials to clinical practice

Sponsor

An increasing amount of clinical evidence has amassed in support of circulating tumor DNA (ctDNA) as a predictive biomarker for immunotherapy response.

Most notably, a Phase 2 study of metastatic solid tumor patients (Bratman et al., Nature Cancer 2020) demonstrated that ctDNA could predict response to pembrolizumab as early as after 2 cycles (approx. 6-7 weeks) of treatment. The latest data from the i-SPY 2 and BELLINI studies, presented at AACR 2022 and ESMO 2022 respectively, suggest that early clearance of ctDNA (after 3-4 weeks of IO) is also associated with treatment benefit in the neoadjuvant setting for breast cancer.

Additionally, stratification of patients by detection of molecular residual disease (MRD) as assessed by ctDNA is shown to predict adjuvant atezolizumab benefit in muscle-invasive bladder cancer, as compared to patients without detectable MRD (Powles et. al, Nature 2021). This analysis has subsequently led to the initiation of a registrational Phase 3 study that uses ctDNA-guided enrollment.

Finally, Medicare reimbursement is available for immunotherapy response monitoring by ctDNA in all approved solid tumor indications, enabling its use in clinical practice.

Join us for a webinar and panel discussion on the ways in which ctDNA is changing immuno-oncology clinical trials and patient management

Latest data from clinical studies leveraging circulating tumor DNA (ctDNA) to select patients most likely to benefit from immunotherapy and to predict therapy response within weeks after beginning treatment
Real-world patient case studies using immunotherapy response monitoring in clinical practice
Opportunities to continue validating ctDNA as a predictive biomarker in patient stratification for clinical trials and identifying responders
Future directions and path to realizing the potential of ctDNA in this setting

Michael Krainock

Associate Medical Director, Oncology Natera

Dr. Michael Krainock, MD, PhD, is a Medical Director in Thoracic Oncology at Natera. Mike 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.

Alan Tan, MD

Director of GU Medical Oncology; Assistant Professor, Department of Internal Medicine, Division of Hematology, Oncology and Cell Therapy, Rush Medical College

Dr. Alan Tan, MD, is an assistant professor in the Division of Hematology, Oncology and Cell Therapy at Rush Medical College. As the Director of GU Medical Oncology, Tan is dedicated to improving the lives of patients with genitourinary tumors. He specializes in kidney cancer, bladder cancer, prostate cancer and melanoma. He also has an extensive background in hematologic malignancies. Tan has clinical research interest in designing and implementing clinical trials to test novel immunotherapies and targeted therapies for renal cell carcinoma and GU malignancies. He also has interest in precision genomic cancer medicine, identifying molecular alterations that will serve as targets for individualized treatment strategies.

John Simmons, PhD

Global Vice President, Biopharma, Natera

John Simmons leads oncology biopharma partnerships at Natera. He received his Bachelor of Science degree in Biology at American University, graduating with Honors. John earned his PhD in Tumor Biology from Georgetown University. Before joining Natera, he completed his postdoctoral fellowship at the National Cancer Institute (NCI) and served as Vice President of Translational Medicine at Personal Genome Diagnostics (PGDx).

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