On November 9th, Friends of Cancer Research (Friends) held the first of two virtual sessions for their 2021 Annual Meeting, celebrating Friends’ 25th anniversary. The focus of Day 1 was the use of circulating tumor DNA (ctDNA) as an early endpoint. The session opened with a few words of welcome from Friends President and CEO, Jeff Allen, who also thanked the many collaborators that contributed to the white paper and Friends’ ongoing ctMoniTR project.
The live event was broadcast through YouTube and is available to watch here.
The first featured highlight was a keynote discussion between Friends’ Chairperson and Founder Dr. Ellen Sigal and Acting FDA Commissioner Dr. Janet Woodcock. Dr. Sigal opened the discussion by thanking Dr. Woodcock and all of the FDA for the work they have done during the pandemic and with the COVID vaccine initiative. They then discussed clinical trial power during the pandemic. Dr. Woodcock noted how only 5-6% of the COVID clinical trials were sufficiently designed to yield actionable data and suggested more involvement is needed with community providers for clinical trials to reach patients where they actually receive care. They also discussed problems facing real world data, digital health tools, and precision medicine. The final topic addressed regulatory changes as a result of COVID, particularly the potential integration of remote assessment and telehealth into the Agency’s work. Both Dr. Sigal and Dr. Woodcock expressed thanks to the FDA and her staff for their continued hard work and dedication to public health.
Janet Woodcock, FDA “Only 8% of cancer patients are offered participation in a clinical trial, we need to do a lot better than that.”
The meeting transitioned to ctDNA as an early endpoint and Dr. Matthew Hellmann of Memorial Sloan Kettering Cancer Center provided background on the use of ctDNA in cancer care. He discussed the many distinct applications of ctDNA, but focused on two settings relevant to current Friends’ work, the neoadjuvant setting and early treatment monitoring in metastatic disease. Both focus on how ctDNA can be used as an early endpoint to assess treatment efficacy, and he anticipates that ctDNA will be a transformative tool for clinical care and research.
Matthew Hellmann, Memorial Sloan Kettering “The common value across all these settings is to bring precision to patients.”
The session culminated with a panel featuring members of the working group who developed the white paper, focusing on leveraging the foundation of the ctMoniTR project to develop a better understanding of how ctDNA can be used as an early endpoint in early-stage disease. The panel was moderated by Kathleen Winson of Genentech and featured Chris Abbosh of AstraZeneca, Valsamo Anagnostou of Johns Hopkins School of Medicine, Jonathan Baden of Bristol Myers Squibb, Reena Phillips and Paz Vellanki of FDA, and Mark Sausen of Personal Genome Diagnostics. They first discussed the early endpoint use case of ctDNA and how having noninvasive procedures for precise information at earlier time points during a patient’s treatment can allow for earlier assessments of treatment benefit. They also talked about the benefits of the collaborative approach of the ctMoniTR project as well as next steps needed in pre-analytical alignment, data supporting ctDNA reduction and survival endpoints, and alignment of methods of ctDNA analysis.
The meeting wrapped up with a few closing remarks from Jeff Allen thanking all the speakers and panelists, as well as a look forward to Day 2 of the Friends Annual Meeting on dose optimization and featuring a roundtable with FDA’s Oncology Center of Excellence leadership.
Be sure to read the white papers for:
Assessing the Use of ctDNA as an Early Endpoint in Early-Stage Disease
Optimizing Dosing in Oncology Drug Development
Stay tuned for additional information and next steps here on our website and social media.