(Cancer of Unknown Primary) Opdivo Approved for Use in Japan

On December 24, 2021, Ono Pharmaceutical Co., Ltd. and a global biopharmaceutical company announced that Opdivo (nivolumab) received approval for the additional cancer indication of cancer of unknown primary (CUP), along with approval for partial changes to manufacturing and sales in Japan.

Cancer of unknown primary (CUP) is a malignant tumor in which the primary site remains unclear even after thorough examination, and is histologically classified as a metastatic tumor. The estimated number of patients in Japan is approximately 3,000 to 13,680. When diagnosed with CUP, most patients have already developed organ metastases, and because a specific treatment plan cannot be clearly established, approximately 80% have poor prognoses. For patients with poor prognoses, drug therapy is the primary treatment option, but no approved drugs have existed domestically or internationally.

This approval was based on the results of the NivoCUP Phase II clinical trial conducted at Kindai University Hospital, which enrolled patients with CUP (poor prognosis) who were either previously treated or treatment-naive and treated them with Opdivo. The primary endpoint was objective response rate in previously treated patients, and secondary endpoints included objective response rate for all patients, overall survival, and progression-free survival.

The trial results showed that the objective response rate in previously treated patients was 22.2%, achieving the primary endpoint goal set before the trial began. The overall objective response rate for all patients was 21.4%, demonstrating antitumor activity with Opdivo regardless of prior treatment history.

Ono Pharmaceutical and the global biopharmaceutical company stated that they hope this approval will establish Opdivo as a new treatment option for patients with cancer of unknown primary.

Source: https://www.ono.co.jp/news/20211224.html

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