High-risk prostate cancer has a high relapse and mortality rate, highlighting the need for more effective therapies. The ADAPPT protocol trial addresses this by enabling neoadjuvant treatment strategies to eradicate detectable disease in patients for whom single treatments are insufficient. Through a multiomic approach to MRD detection we aim to establish a six-month regulatory efficacy endpoint, which will help predict treatment resistance and expedite drug development to improve patient outcomes.

Justin Odegaard, Vice President of Clinical Development at Guardant Health, will explore how liquid biopsy technology combined with AI is transforming precision oncology. The session will cover the latest breakthroughs in detecting minimal residual disease and applying genomic insights to optimize cancer treatment decisions, ultimately advancing patient outcomes in clinical care.

As technology continues to advance towards new non-invasive cancer screening modalities, particularly blood-based testing, the U.S. health care system lags in its ability to ensure a pathway to coverage and access for patients. This talk will summarize the U.S. policy environment related to cancer screening coverage, identify gaps, and consider potential solutions to accommodate emerging blood-based cancer screening tests.

Using NSCLC as an example, this session will cover current adoption of liquid biopsy testing´(LBx) and review the key milestones which have driven incorporation into routine clinical diagnostic. Learnings from NSCLC can help further explore what’s needed to establish LBx broadly. In the talk, Susanne Munksted will explore current usage, uptake and coverage of LBx and address the challenges that still exists which inhibit us from harnessing the full potential of liquid biopsy testing to diagnose and guide treatment decisions.

Traditional survival endpoints like Overall Survival (OS) or Progression-Free Survival (PFS) often necessitate lengthy follow-up periods, which can be impractical for obtaining early efficacy signals in the dose-escalation and expansion phases of clinical development. While radiographic endpoints based on RECIST (Response Evaluation Criteria in Solid Tumors) offer earlier insights into potential long-term benefits, they have limitations, especially in patient populations where stable disease (SD) is observed. Consequently, there is a critical need for novel endpoints that can provide more timely predictions of clinical benefit. LBx-based biomarkers, specifically circulating tumor DNA (ctDNA), have paved new paths for monitoring and predicting treatment outcomes. This presentation will explore: 1) how incorporating ctDNA as a molecular response biomarker in early clinical trials enhances patient risk stratification; 2) case studies demonstrating how molecular response assessments using ctDNA can predict clinical outcomes; and 3) the integration of ctDNA data with radiographic imaging to support early Go/No-Go decisions in clinical trials.

Working to align the liquid biopsy community through collaboration. The BLOODPAC MRD AV working group has recently published the Tumor-informed MRD Generic Analytical Validation Protocols. As the field continues to expand, the group will work to develop tumor agnostic MRD AV protocols. The session will discuss how we got here, how we move forward, and how these decisions will impact the patient journey as well as work to reduce costs associated with treatment of disease recurrence.

DELFI- tumor fraction (DELFI-TF) is a tumor agnostic, mutation independent whole genome sequencing test to determine the genome wide circulating tumor (ctDNA) burden. DELFI-TF scores are independent predictors of overall survival (HR = 9.84, 95% CI = 1.72-56.10, p < 0.0001). This presentation will discuss the potential to use cfDNA fragmentomes to estimate tumor burden in cfDNA for treatment response monitoring and clinical outcome prediction.