June 15, 2023
Keio University School of Medicine
Keio University Hospital
Today, efficacy was demonstrated in the primary endpoint of objective response rate (ORR) by central review in the "Investigator-initiated, multicenter, phase II clinical trial of anti-PD-1 antibody therapy for cutaneous epithelial malignancies." This investigator-initiated, multicenter clinical trial was led by a group from the Department of Dermatology, Keio University School of Medicine, including Associate Professor Ken Funakoshi and Senior Lecturer Yoshio Nakamura. Based on these results, Ono Pharmaceutical Co., Ltd., the manufacturer and distributor of Opdivo, has submitted a supplemental application for a partial change in the approved items of the domestic manufacturing and marketing approval for the indication of unresectable advanced or recurrent cutaneous epithelial malignancies.
Cutaneous epithelial malignancies are a general term for skin cancers systematically classified as epithelial tumors, and include squamous cell carcinoma, basal cell carcinoma, extramammary Paget's disease, and cutaneous adnexal carcinomas (such as sweat gland carcinoma, sebaceous carcinoma, and hair follicle carcinoma). In Japan, a standard of care has not yet been established for unresectable advanced or recurrent cutaneous epithelial malignancies, and the development of new drugs has been eagerly awaited.
The aforementioned clinical trial, which served as a key basis for this supplemental application, was conducted with the support of Ono Pharmaceutical Co., Ltd. It was based at Keio University Hospital and carried out jointly by eight institutions nationwide, including Tohoku University Hospital, Niigata Cancer Center Hospital, the National Cancer Center Hospital, Nagoya University Hospital, Kyoto University Hospital, Wakayama Medical University Hospital, and the National Hospital Organization Kyushu Cancer Center. Additionally, on May 23, 2023, Opdivo was designated as an orphan drug by the Ministry of Health, Labour and Welfare for the indication of unresectable advanced or recurrent cutaneous epithelial malignancies and is subject to priority review.
For the full press release, please see below.