February 24, 2022:

Just over 50 years ago, President Richard Nixon signed the National Cancer Act – more commonly known as the “War on Cancer.” While harnessing the resources of the federal government was an important step forward, many have commented (including current NCI director Dr. Ned Sharpless) the effort was simultaneously ambitious and naïve. Naïve in the sense that we did not yet understand our enemy. About 25 years into the “war,” the New England Journal of Medicine published an article entitled, “Cancer Undefeated” wherein declining death rates were attributed to changing incidence rates and early detection practices (Bailar, et al. N Engl J Med 336:1569 1997 PMID: 9164814), not because of advances in therapy.

In 2016, then Vice President Biden re-committed the federal government to cancer research by announcement of the Moonshot initiative and stated, “research and therapies are on the cusp of incredible breakthroughs” (Cancer Letter, January 22, 2016). At that time, he emphasized collaboration and data sharing to include collaboration with the private sector.

More recently, on February 2, 2022, President Biden announced Moonshot 2.0 will build on advances in cancer research and informatics supported by the federal government. Even the most cynical observers would have a hard time arguing we have not made progress in the past 25 years. Development of molecular predictive biomarkers, cellular therapies, immune checkpoint inhibitors, small molecules based on mutated proteins, and antibody-drug conjugates are only a few of the advances improving cancer outcomes and, hopefully, accelerating further decreases in cancer mortality. None of these strategies existed, or were even feasible, when the National Cancer Act was signed and one can draw a direct line between funding biomedical research and improved clinical outcomes.

Moonshot 2.0 has seven pillars (Cancer Letter, Feb 18, 2022) designed to address important key issues in with the goal of halving cancer deaths over 25 years (“diagnose cancer sooner, prevent cancer, address inequities, target the right treatments to the right patients, speed progress against the most deadly and rare cancers, target the right treatments to the right patient, support patients, caregivers, and survivors, and learn from all patients”). One pillar, to “target the right treatments to the right patient” presents a major opportunity for our Big Ten Cancer Research Consortium. This goal of precision therapy – or the Goldilocks principal of “just right” therapy – can only be discovered through clinical trial conduct. The Big Ten Cancer Research Consortium exists to conduct trials in a collaborative environment.

While all the tools for achieving these goals have not been full detailed or funded, the creation of the Advanced Research Projects Agency for Health (ARPA-H) describes a vision for a funding mechanism with the “potential to transform important areas of medicine and health for the benefit of all patients and that cannot readily be accomplished through traditional research or commercial activity (https://www.nih.gov/arpa-h).” Clinical trials, and novel clinical trial designs, will certainly be key in transforming outcomes for patient with cancer and people at risk of developing cancer.

Certainly, successful and practice changing trials are aiming directly to the address the issue of right treatment for the right patient. The Masonic Cancer Center, University of Minnesota has been involved with the I-SPY TRIAL, a neoadjuvant breast cancer trial designed to evaluate investigational therapies in operable breast cancer. This trial, led by Drs. Laura Esserman (UCSF) and Donald Berry (MDACC) is designed as a standing phase II platform trial with a goal of identifying activity for new drugs matched to specific tumor biologies. I serve as the co-chair of the Agent Selection Committee. Currently, there are 27 open sites (including Ohio State and Rutgers) and is supported by private, academic and industry partnerships. Using adaptive randomization and the primary endpoint of pathologic complete response, we have evaluated 23 drug regimens over the past decade. Because it is a platform trial and multiple arms can be open at any one time, there are no “stops and starts” associated with typical single arm trials. My involvement with this trial has emphasized how promising agents, novel trial designs, biomarker discovery, and collaboration between academic centers and industry can advance the field. This is one of many examples of strategies designed to speed progress, engage patients in a research partnership, and engage the multiple stakeholders necessary to change practice.

Clinical trials ARE the shoulders upon which improved outcomes stand. The Big Ten Cancer Research Consortium is well poised to design and create and execute novel trial designs in cancer prevention, health equity, treatment, and survivorship – essentially all of the Moonshot 2.0 pillars. The Consortium brings together major academic institutions and once the full details of ARPA-H are articulated the consortium will be well situated to forge collaborations between the federal government, academia, and industry.

Yogi Berra could have commented this is just “déjà vu all over again,” but I think we are much better positioned and equipped as a clinical and research community to reach our goals of reducing cancer morbidity and mortality. We have come a long way from the 1971 National Cancer Act. I hope to see the consortium play an important role in Moonshot 2.0 and lead in multiple areas.

Douglas Yee, MD is a medical oncologist and the director of the Masonic Cancer Center; Professor, Medicine – Hematology, Oncology, Transplant and Professor, Pharmacology at the University of Minnesota Medical School. 

About the Big Ten Cancer Research Consortium: The Big Ten Cancer Research Consortium was created in 2013 to transform the conduct of cancer research through collaborative, hypothesis-driven, highly translational oncology trials that leverage the scientific and clinical expertise of Big Ten universities. The goal of the Big Ten Cancer Research Consortium is to create a unique team-research culture to drive science rapidly from ideas to new approaches to cancer treatment. Within this innovative environment, today’s research leaders collaborate with and mentor the research leaders of tomorrow with the unified goal of improving the lives of all patients with cancer.

About the Big Ten Conference: The Big Ten Conference is an association of world-class universities whose member institutions share a common mission of research, graduate, professional and undergraduate teaching and public service. Founded in 1896, the Big Ten has sustained a comprehensive set of shared practices and policies that enforce the priority of academics in the lives of students competing in intercollegiate athletics and emphasize the values of integrity, fairness and competitiveness. The broad-based programs of the 14 Big Ten institutions will provide over $200 million in direct financial support to more than 9,800 students for more than 11,000 participation opportunities on 350 teams in 42 different sports. The Big Ten sponsors 28 official conference sports, 14 for men and 14 for women, including the addition of men’s ice hockey and men’s and women’s lacrosse since 2013. For more information, visit www.bigten.org