Craif Inc. (Location: Bunkyo-ku, Tokyo, CEO: Ryuichi Onose, hereinafter referred to as “Craif”) has entered into a joint study agreement with Tokyo Medical University Foundation (Location: Shinjuku-ku Tokyo, Chairman of the Board Regents: Yoshio Yazaki, hereinafter referred to as “Tokyo Medical University”). With the conclusion of this agreement, Craif and Urology Department (Principle Investigator: Yosuke Hirasawa Lecturer) of Tokyo Medical University will begin a joint study to discover predictive biomarkers for immunotherapy efficacy in patients of urothelial cancer utilizing urinary miRNA.

■ Outline of this Study
Urothelial cancer accounts for about 90% of all bladder cancers (*1), and the 5-year survival rate for metastatic cases is only about 9.5% (*2). For the past 30 years, the standard treatment for advanced urothelial cancer has been chemotherapy, which is done with several types of drugs. However, it has been found that although the response rate to chemotherapy is high in the early stages of treatment, long-term persistence and complete response are rare, and in many cases, progression is observed within 9 months after the start of treatments (*3) (*4). Immunotherapeutic drugs have been widely used in recent years as salvage or maintenance therapy for patients with recurrence of advanced urothelial cancer after chemotherapy. However, the response rate of that therapy is low (*5) and there is no simple biomarker to predict its efficacy. Furthermore, immunotherapeutic drugs are expensive and have unique side effects such as newly classified “immune-related adverse events (irAEs).” For the sake of improving response rates and optimizing medical costs, this study aims to develop predictive biomarkers for immunotherapy efficacy in patients of urothelial cancer utilizing urinary miRNA.

（*1） American Society of Clinical Oncology (ASCO). “Bladder Cancer: Introduction”. Cancer. Net.  https://www.cancer.net/cancer-types/bladder-cancer/introduction, (Janurary 2020)
（*2）National Cancer Center Japan. “がん種別統計情報”. がん情報サービス. https://ganjoho.jp/reg_stat/statistics/stat/cancer/21_bladder.html, (Janurary 2020)
（*3） Bukhari, N., Al-Shamsi, H. O., & Azam, F. (2018). Update on the Treatment of Metastatic Urothelial Carcinoma. TheScientificWorldJournal, 2018, 5682078. https://doi.org/10.1155/2018/5682078
（*4） Von der Maase H, et al. Comparing Gemcitabine Plus Cisplatin, With Methotrexate, Vinblastine, Doxorubicin, Plus Cisplatin in patients With Bladder Cancer. Journal of Clinical Oncology. 2005;23(21):4602-4608.
（*5）Bellmunt J et al. N Engl J Med 2017; 376: 1015-1026