January 6, 2021
Keio University School of Medicine
International University of Health and Welfare School of Medicine
Japan Agency for Medical Research and Development
Professor Daisuke Aoki and Senior Lecturer Taku Iwata of the Department of Obstetrics and Gynecology, Keio University School of Medicine, and Professor Yutaka Kawakami, Dean of the School of Medicine at the International University of Health and Welfare (who also serves as a professor in its Department of Immunology and as a Project Professor in the Division of Cellular Signaling, Institute for Advanced Medical Research, Keio University School of Medicine), have submitted a Class III Regenerative Medicine Provision Plan to the Ministry of Health, Labour and Welfare for "Tumor-Infiltrating Lymphocyte (TIL) therapy for cervical cancer," and this clinical trial was initiated on January 5, 2021. This TIL therapy was approved as a Class III Regenerative Medicine Provision Plan by Keio University's Special Certified Committee for Regenerative Medicine in November 2019 and was authorized as Advanced Medical Care by the Ministry of Health, Labour and Welfare's Advanced Medical Care conference in December 2020. As this treatment first requires the collection of peripheral blood mononuclear cells from healthy donors as the raw material for the TIL product, treatment for patients is scheduled to begin in March.
Advanced or recurrent cervical cancer is extremely difficult to treat, and effective drugs are limited. TIL therapy is a type of adoptive immunotherapy in which immune cells called lymphocytes, found within the patient's own cancer tissue, are collected, cultured in large quantities outside the body, and then returned to the patient. A noteworthy feature of TIL therapy, in addition to its expected high response rate, is that when cancer is eliminated by TIL therapy, subsequent recurrence is rare, and it has been reported that a complete cure may be possible. This makes it a promising treatment for patients for whom conventional therapies have been ineffective. However, because this treatment requires advanced TIL culturing techniques, only about 10 facilities worldwide are capable of performing it. Professor Yutaka Kawakami and his team have established this TIL culturing technology in Japan and have already administered TIL therapy to three patients with malignant melanoma in 2016. Based on these results, TIL therapy will now be administered to a maximum of 14 patients with advanced cervical cancer.
Please see below for the full press release.