Changing the game of precision medicine in the Land of the Rising Sun
Japan has a great number of ongoing clinical studies and has played a critical role in the greater global understanding of the role of biomarkers and empower precision medicine. Yet, it has been one of the latter of the developed countries to adopt and reimburse broad Next Generation Sequencing (NGS)-based testing in clinical routine diagnostics. But change has come, it has occurred quickly. Within less than 18 months, Japan approved the first NGS panel as an IVD in 2017 and the first companion diagnostic (CDx) in 2018. These changes were followed by changes in reimbursement in 2019, which now includes the Oncomine and FoundationOne panels and the National Cancer Center (NCC) Oncopanel. The Pharmaceuticals and Medical Devices Agency (PMDA) has even signalized a change in the strategy moving forward with multi-biomarker and pan-tumoral CDx panels; this has materialized last week with the approval of FoundationOne as the CDx for entrectinib to identify patients with NTRK fusion-positive advanced and recurrent solid tumors.
The instigating events that led to these recent, concrete changes started in 2013 with the initiation of LC-SCRUM-Japan. Initially created to screen for patients that carry fusion alterations in non-small cell lung cancer (NSCLC), the SCRUM program has expanded its purpose to incorporate more comprehensive testing by NGS, both of DNA and RNA (by Oncomine) and more recently incorporated liquid biopsy testing (by the Guardant360 panel). This inclusion of wider methodology has enabled greater patient participation in clinical trials. In 2018, the Japanese government designated 11 hospitals to constitute the core for cancer medicine genomics in the country and created the Cancer Genomics and Advanced Therapeutics (C-CAT) to be the new hub of cancer genomic medicine. Nationally, Japan Agency for Medical Research and Development (AMED) aims to create the next-generation of personalized medicine through projects like the Tohoku Medical Megabank project, promotion of genome medicine, enhanced integration of clinical and genomic data, and the promotion of genomic-based drug discovery. Clinical and genomic data collected and managed within this context has become very attractive for pharma to better select and enroll patients in clinical trials.
This more favorable environment has caught the attention of both pharmaceutical and diagnostic companies, with new approvals for diagnostics from Myriad and Invivoscribe. Impressively, Japan became the first country to approve entrectinib, Roche’s tyrosine kinase inhibitor targeting TRK and ROS1. Qiagen is another recent example of a life sciences company benefiting from the recent improved precision medicine environment in Japan. In June 2019, they were selected as a provider for the C-CAT with a bioinformatic solution to better identify the most suitable targeted therapy for patients and clinical trial options. As a further example is the approval for FoundationOne as a CDx. This required an innovative solution to allow for FoundationMedicine (FMI)’s business model of centralized assays; sequencing is performed outside of Japan but physicians receive the XML file, which can be uploaded into the local FMI portal, which annotates any variants and generated and returns the final report. This constitutes a programming device, which can be regulated by the PDMA.
The road to the greater that was started in 2013 has allowed Japan to create the infrastructure and mindset necessary to catapult the country towards global leadership in precision medicine and will fuel even more the biotechnology growth and investment in Japan. Enlargement of the core cancer medicine genomics to 40 centers and increased connection and harmonization between the different players in the healthcare sector will further facilitate the implementation of innovations and contribute for the current precision medicine momentum. It is time to think big in Japan.
If you are interested in knowing more about the recent events in Japan, having more insights or uncovering how IPBA can help you with your CDx strategy worldwide, do not hesitate to contact us.
Luiz Gustavo Guedes Correa, PhD