On Tuesday, August 11, 2020, Friends of Cancer Research (Friends) presented the results of Step 1 of the ctDNA for Monitoring Treatment Response (ctMoniTR) project. Step 1 involved convening clinical and academic leaders, government, industry, and leading advocates to align on a methodology to analyze ctDNA (circulating tumor DNA) data from past clinical trials in lung cancer investigating immune checkpoint inhibitors. The hope was that this collaborative effort would bring together a larger and more robust combined dataset than if any one stakeholder attempted to compile these data on their own.
The meeting opened with remarks from Ellen Sigal, Founder and Chairperson of Friends, followed by an introduction from Jeff Allen, President and CEO of Friends, on how the project was conceived and developed. Following the introduction, an overview of the project was provided by Julia Beaver, Chief of Medical Oncology at the FDA. She set the stage by highlighting how the evidence of ctDNA as a tool that monitors treatment response has been limited and thus it has been difficult to pull broad understanding. The framework of the ctMoniTR project was created to fill this gap in understanding and set a foundation for future direction to work on guidelines for standardized ctDNA assessment.
Following the project overview, Diana Merino Vega, Director of Research Partnerships at Friends, presented the project findings from Step 1 of the project. The objective of Step 1 was to see if data from multiple clinical trials could be harmonized, and if promising trends observed in smaller datasets could be replicated in larger, more robust datasets. The results demonstrated that these same trends were observed in the larger pooled dataset, as strong associations were observed between strong decreases in ctDNA and overall survival (OS) and progression-free survival (PFS), durable clinical benefit (defined as PFS at greater than 6 months) and tumor response (defined as partial response of better).
The project findings were followed by a panel discussion, moderated by Nevine Zariffa of the NMD Group. The panel of experts was composed of Roy Herbst of Yale Cancer Center, Antje Hoering of Cancer Research and Biostatistics (CRAB), Geoff Oxnard of Foundation Medicine (FMI), David Raben of Genentech, with Beaver answering some audience questions. Topics discussed included reactions to the findings, how the data would inform the next wave of clinical trials and practice, and how ctDNA compares to other biomarkers in a regulatory space. Looking forward, the panelists agreed that further work to assess and compare ctDNA assays is still needed, as well as analyses of longitudinal prospectively-collected data.
Both the presenters and panelists also reaffirmed the need for new sponsors, stakeholders, and collaborators for Step 2 of the ctMoniTR project. Step 2 aims to broaden the application of Step 1 by looking at different tumor types, drug classes, disease stages, as well as looking at longitudinal prospective data with a goal to produce results by 2022. Thus, additional partners who are willing to contribute data and their unique expertise are needed in order to show broader results in a faster time frame.
The event concluded with closing words from Jeff Allen, thanking the participants, collaborators, and viewers. Be sure to tune in to the Q&A virtual meeting on Tuesday 8/25 to answer questions on the project, as well as the next virtual meeting in September on Real World Evidence.
Click HERE to watch the full virtual meeting.
ctMoniTR Virtual Q&A
The strong interest in the ctMoniTR results virtual meeting led to so many great questions and engagement that Friends of Cancer Research coordinated its first ever virtual Q&A session to address these important questions. The meeting began with opening words from Friends’ founder, Ellen Sigal, as well as a quick introduction by Friends’ CEO, Jeff Allen. To serve as a quick recap of the first meeting, Katherine Nishimura of CRAB went over the key findings of the ctMoniTR project to serve as an overview for the ensuing discussion. The highlight of the meeting was the 12-person discussion (discussants listed below), again moderated by Nevine Zariffa of the NMD group. They answered an array of questions, including a mix of questions raised at the the August 11 meeting and new questions asked by the audience of the virtual Q&A. Topics included questions on how the Step 1 data were interpreted, how the findings can be applied in clinical and regulatory settings, and how this work can accelerate benefit to patients. The discussants also commented on possible opportunities and gaps in the field that the ctMoniTR project may be able to address, particularly as the direction and scope of Step 2 is being refined. General conclusions were that more longitudinal data, especially more uniform data consisting of plasma collected at specific timepoints from studies investigating additional tumor types, drug classes and stages of disease, were still needed. The results of Step 1 were very promising and provided the foundations for Step 2, which will help establish ctDNA as a tool to more rapidly and less invasively determine whether a patient is responding to treatment.
Panelists included: John Baden, BMS; Carl Barrett, AZ; Erik Bloomquist, FDA; Darya Chudova, Guardant Health; Matthew Hellman, Memorial Sloan Kettering Cancer Center; Roy Herbst, Yale; Antje Hoering, CRAB; Geoffrey Oxnard, FMI; Reena Philip, FDA; Diana Merino Vega, Friends; Qi Xia, Genentech.
Click HERE to watch the full virtual Q&A.