Report on cancer research strategies for the next decade submitted by the government's expert committee

What will be the focus of cancer research in the next decade? The government's Expert Committee on the Vision for a Better Future of Cancer Research (chaired by President Hitoshi Nakagama of the National Cancer Center (NCC)) has submitted a report that will shape the Japanese cancer-research strategy for the next decade, starting in FY2024. The current Basic Plan to Promote Cancer Control program outlines three overarching goals of cancer research: 'cancer prevention,' 'cancer diagnosis and treatment,' and 'coexistence with cancer.' Now, the report also focused on cross-disciplinary research and research specific to the life stage and cancer characteristics. The report also includes committee members' opinions on issues related to the existing research system in order to effectively promote research and implementation in society.

In Japan, cancer has been a leading cause of death since 1981, and estimates suggested that by 2022, about 390,000 people (i.e., one in four people) have died of cancer annually. It was also estimated that about one million people would be diagnosed with cancer in FY2019 and that one in two people would suffer from cancer during their lives. Moreover, the number of patients with cancer and related deaths is expected to increase with the rapidly aging population. Meanwhile, patients' prognoses have been improving, and they can now continue to work and enjoy life while being treated for cancer.

Since 1984, the government has been tackling cancer from various perspectives with the Comprehensive 10-year Strategy for Cancer Control, and since FY2014, the government has employed a research-focused strategy (i.e., a 10-year strategy for cancer research). The aforementioned report presents the specifics of the second phase of this strategy.

The direction set by the current report attaches more importance to basic research compared to that of the previous report from 10 years ago. Above all, the direction for the incorporation of advanced science and technology, including artificial intelligence (AI), which was highlighted in the interim evaluation, have been included for the first time.

AI is being used in the development of surgical support systems and genome medicine. On top of this, advanced science and technology (generative AI and quantum technology) can potentially contribute to the development of new treatments. Hence, opportunities exist for applying advanced science and technology not only in cancer prevention and detection, but also in overall research and development (e.g., drug discovery and treatment methods). The report describes a broad portfolio of research, such as (1) research regarding the underlying biological mechanisms of cancer and drug discovery through multidisciplinary approaches (i.e., combining life sciences and advanced fields, such as imaging engineering, computational science, materials science, physics, chemistry, engineering, and information science); (2) development of detection technologies using new sensing techniques gauging exhalation and taste; (3) utilization of quantum sensors; and (4) development of new technologies that include modified therapeutic antibodies, such as bispecific antibodies, cancer vaccines (e.g., neoantigen vaccines), and genome-edited T cell therapies (e.g., CAR-T cell therapy and TCR-T cell therapy).

Regarding life-stage-specific cancer research, the report provides detailed research axes for cancers affecting children, adolescents and young adults (AYAs), and older adults. One key to solving these matters is making the most of real-world data.

In research with respect to cancer in young people, the following studies are prioritized: (1) research on therapies targeting fertility preservation and oncofertility care; (2) establishment of a long-term follow-up system and information collection framework for patients with pediatric cancer with a view toward international collaboration; (3) research that contributes to solving psychological and social issues, including the financial burden on patients with pediatric and AYA cancer and their families; and (4) additional measures for satisfying patients' needs previously unmet with the available education and employment assistance.

Given the expectation that cancer in older adults will increase in the future and that their conditions vary greatly depending on the individual, the report highlights the following research topics: (1) clinical research related to the verification and implementation of the efficacy and safety of new treatments and technologies, including the use of real-world data that takes into account comorbidities and organ damage, and (2) research on cancer-related interdisciplinary fields (e.g., cardio-oncology and onconephrology for older cancer patients).

This report also includes recommendations to improve the current research system for effectively promoting research, which were not mentioned in the previous report. These include the establishment of a system that enables the development of drugs for adults and children in parallel, as in other countries. For certain diseases, it is difficult to enroll patients for clinical trials in Japan. In such circumstances, a system should be considered whereby drugs approved overseas could be provisionally approved based on overseas data. Further, final approval could be completed with post-marketing, real-world data. In the early stages of pioneering research, instead of waiting for out-licensing from a company or the results of investigator−initiated clinical trials (which could potentially lead to the development of a new drug or medical device), it is necessary to arrange a consultation or provide accompanying support for commercialization as appropriate. Considering the importance of computational technologies necessary for data integration, the unification of aggregate definitions and standardization of electronic health records should be considered.

Many of the recommendations mentioned above are common to the development of new drugs, therapeutic devices, and treatments for all diseases and not specific to cancers. Therefore, how the government addresses these issues will be crucial.

In connection with this report, the Ministry of Education, Culture, Sports, Science and Technology (MEXT) has requested a new budget for strategic research (innovative basic research) under the Project for Promotion of Cancer Research and Therapeutic Evolution (P-PROMOTE).

Kyoto University's OPDIVO was developed through a collaboration of immunology and genetic engineering. Similarly, KYMRIAH was created at the University of Pennsylvania, U.S.A., through a synergy of immunology, genetic engineering, and regenerative medicine. Therefore, transdisciplinary research will be pursued by supporting the first-line fields of cancer research (immunology, regenerative medicine, genetic engineering, epigenomics, nuclear medicine, aging biology, and cancer prevention), combined with advanced technologies (imaging technology, AI, quantum technology, and mass spectrometry), thereby promoting basic research with the aim of creating groundbreaking potential from academia.

There is a sense of impending crisis that the potential therapeutic opportunities for the next generation and beyond would be lost without transdisciplinary research. The coming budget negotiations must be closely followed.