Charting the Path for ctDNA as an Early Endpoint in Early-Stage Disease

November 3, 2021

The Friends of Cancer Research (Friends) Annual Meeting provides a venue for multiple stakeholders to discuss pressing issues in oncology drug development, providing potential opportunities to overcome challenges and spur future collaborative work. The session on Day 1 of the Friends Annual Meeting 2021 will focus on building a roadmap for the use of changes in circulating tumor DNA (ctDNA) levels as an early endpoint to predict long-term survival outcomes in early-stage disease to support regulatory approval.

ctDNA is DNA that originates from tumor cells and is found in the bloodstream. There are many opportunities to use ctDNA tracking in early-stage disease, with potential for monitoring ctDNA to detect disease burden earlier and in a less-invasive manner than current imaging or biopsy technologies. One transformative use of ctDNA is as a biomarker for a patient’s response to therapy as an early endpoint to predict long-term survival. This may allow for expedited drug development, by identifying efficacious drugs more quickly in clinical trials and enabling access to promising therapies faster for patients with cancer.

Validating ctDNA as an early endpoint will require large datasets with robust clinical and ctDNA data, as well as collaboration across sponsors for analysis from multiple clinical trials. Friends’ previous ctMoniTR efforts in late-stage disease affirms this type of collaboration is possible and provides the foundation to establish a roadmap for investigating the use of this novel endpoint in early-stage disease. Friends therefore convened a multi-stakeholder group of experts in ctDNA and early-stage disease to help establish this roadmap.

“We are excited to be part of this multi-stakeholder collaboration led by Friends and about the opportunity this can represent for patients.  Our ability to expedite innovative medicines depends on developing better biomarkers and novel endpoints. By more effectively leveraging data generated across industry, government and academia, we can accelerate our understanding of the utility of ctDNA in early-stage disease and its potential as an endpoint in this setting.” - Kathleen Winson, Executive Group Director, Product Development Regulatory, Genentech, a member of the Roche Group.

The roadmap is built on the outstanding clinical question focused on whether changes in ctDNA in response to a drug reflect long-term outcomes on a trial level, and if the predictive value varies by therapy setting, therapeutic class, or tumor type. Due to the nature of early-stage disease studies, including the size and trial length, proactive planning of the necessary data elements is needed to efficiently answer the clinical questions and allow for better data contextualization. The group described key categories of clinical data elements where alignment will be important. 

“Given the emerging interest in ctDNA as a biomarker at multiple points in a patient’s cancer journey it is important that our community aligns on technical and patient outcome data that our trials should be reporting. By pre-specifying data elements that should accompany early-stage clinical trials incorporating ctDNA as a biomarker we hope to pave the way for future meta-analytic approaches that will allow us to comprehensively assess the value of ctDNA as a study endpoint”. - Chris Abbosh,  AstraZeneca Fellow, Translational Medicine, AstraZeneca

Important considerations for charting the path for use of ctDNA as an endpoint will be described in a white paper to be released concurrently with the Annual Meeting and during the Day 1 Annual Meeting Session. 
 

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