On March 29th, Friends of Cancer Research (Friends) convened a virtual meeting to discuss the use of multi-cancer early detection (MCED) screening tests, a promising technology that may support earlier detection of cancers. Dr. Ellen Sigal, Friends’ chair and founder, opened the meeting by highlighting the potential for MCED screening tests to shift the trajectory of cancer diagnoses, treatment, and patient outcomes. She then introduced the keynote speaker, National Cancer Institute (NCI) Director Dr. Ned Sharpless, who opened his address acknowledging the arrival of what he calls “the golden age of possibility” in cancer research. Dr. Sharpless expressed his belief that we will accomplish President Biden’s goal to cut cancer mortality in half over the next 25 years. He also described challenges that will need to be addressed to achieve this goal, including reducing morbidity and toxicities associated with cancer therapies, eliminating health disparities, and enhancing our ability to detect cancer earlier. Dr. Sharpless emphasized the tremendous potential for MCED screening tests to help address these challenges at the population level, as well as the need for rigorous evaluation through regulatory pathways to assess the safety and effectiveness of these tests.
Next, Dr. Jeff Allen, President and CEO of Friends, welcomed a panel of experts to discuss opportunities to generate meaningful real-world evidence (RWE) to inform regulatory decision-making for MCED screening tests. Dr. Dan Hayes moderated the panel which featured Dr. Ruth Etzioni, Dr. Girish Putcha, Mr. Sam Roosz, Dr. Wendy Rubinstein, and Ms. Seema Singh Bhan. The panel covered a wide range of topics including study designs and evidentiary needs for MCED screening test evaluation, opportunities from and limitations of the current paradigm of single-cancer screening tests for evaluation of MCED screening tests, and the role real-world data (RWD) may play in generating evidence to support regulatory decisions about MCED screening tests. Panelists noted the need for a new regulatory framework and pathway to evaluate MCED screening tests and described the differences between evidentiary needs of single-cancer screening tests versus MCED screening tests. The panel highlighted that RWD, if collected appropriately and rigorously, can provide meaningful supplementary evidence to support use of MCED screening tests. They also acknowledged that randomized clinical trials with cancer-specific mortality as the endpoint remain the gold standard for ultimate evaluations of the clinical utility of MCED screening tests.
Dr. Allen introduced the second panel, moderated by Dr. Ernest Hawk, which discussed potential implications of MCED screening tests and how they might alter the future of drug development. The panel featured Dr. Nicole Drezner, Dr. Dina Gifkins, Ms. Jody Hoyos, Dr. Joshua Ofman, and Dr. Nickolas Papadopoulos. They addressed topics including how MCED screening tests could influence the approach to future therapeutic interventions, their implications on screening, and the priorities to help realize their promise. Like the first panel, the panelists discussed how the additional complexity of MCED screening tests necessitates a different evaluation strategy than single-cancer screening tests. They also emphasized the need to develop novel trial designs that use MCED screening tests at various timepoints in the conduct of a trial, as well as building the right regulatory pathways and predictive models to utilize MCED screening tests effectively.
Finally, Dr. Allen concluded the meeting thanking all the speakers and panelists for helping identify challenges and transformative opportunities for the future of MCED screening tests.