Annual Report 2024

Preface

The Center for Cancer Genomics and Advanced Therapeutics (C-CAT) was established on June 1, 2018, within the National Cancer Center, Japan, to aggregate, store, and support the utilization of cancer genomic medicine data generated by cancer gene panel testing (comprehensive genomic profiling) conducted under the national health insurance system in Japan.

C-CAT is organized into eight sections: the Section of Cancer Genomics Repository, responsible for receiving clinical information from medical institutions; the Section of Genomic Data Management, which collects test results from diagnostic companies; the Section of Knowledge Integration, which produces "C-CAT Findings" reports based on both clinical and test data; the Section of Information Technology Support, managing networks with medical institutions and testing companies; the Section of Data Science Strategy, which promotes the utilization of aggregated data; the Section of Genome Analysis Platform, which develops data utilization systems using cloud-based solutions; the Section of Liaison for Cancer Genomic Medicine Hospitals, working closely with medical institutions; and the Administration Office, which handles administrative functions. From fiscal year 2023, I assumed leadership from the founding director, Dr. Mano, and continue C-CAT’s operations.

In fiscal year 2024, Japan marks the sixth year since cancer genomic medicine with gene panel testing became available under the national health insurance system. Currently, Japan’s cancer genomic medicine is delivered by 13 Designated Core Hospitals, 32 Designated Hospitals, and 234 Cooperative Hospitals across the country. Results from cancer gene panel testing are discussed by expert panels, comprising multidisciplinary teams who provide treatment recommendations for each patient. C-CAT generates "C-CAT Findings" reports, which include clinical annotations such as information on relevant clinical trials and investigational studies matching each patient’s cancer type and genetic mutations, and these reports are sent to cancer genomic medicine hospitals. By the end of fiscal year 2024, the number of patients whose data had been submitted to C-CAT exceeded 100,000. Over 99% of patients have consented to the secondary use of clinical genome data submitted to C-CAT.

C-CAT compiles metrics such as the rate of therapeutic option proposals and the implementation rate of proposed treatments from expert panel discussions following cancer gene panel testing. These metrics are incorporated as evaluation items in the 4th Basic Plan to Promote Cancer Control Programs and serve as indicators for the national monitoring of cancer genomic medicine. According to C-CAT data, therapies administered to patients include those covered by insurance, industry-sponsored trials, Patient-Proposed Health Services program (BELIEVE trial), and investigator-initiated trials, in that order. Notably, treatments received through clinical trials constitute only 20% of the total, highlighting the need to increase trial participation as a critical goal for enhancing Japan's cancer genomic medicine framework.

The "C-CAT Research Use Portal," developed to facilitate research and development in drug discovery and other areas using C-CAT data, is currently utilized by 124 groups, including 10 pharmaceutical companies and 46 academic institutions. Data usage is governed by fair review through the C-CAT Data Utilization Review Board, which gives permission for data access. Research outcomes from data utilization include over forty scientific papers that have elucidated the genetic characteristics of various cancers in the Japanese population. There has been one case in which a pharmaceutical company used C-CAT data to seek an expanded indication for a molecularly targeted therapy, indicating that regulatory use of C-CAT data has begun.

The dedicated public website, "Cancer Genomic Medicine and Cancer Gene Panel Testing," receives over 30,000 page views per month, and C-CAT's X account, with approximately 4,300 followers, has proven to be a successful outreach platform, raising public awareness about cancer genomic medicine. Going forward, C-CAT will continue to work closely with cancer genomic medicine stakeholders, including patients and their families, to support the development and operation of a globally unique system for aggregating, storing, and utilizing clinico-genomic data within Japan’s universal healthcare framework, thereby advancing cancer care as well as research and development.

Takashi Kohno, Ph.D.

Director, Center for Cancer Genomics and Advanced Therapeutics