Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President: Toichi Takino) announced today that its Korean subsidiary, Ono Pharma Korea Co., Ltd. (OPKR), received additional approval from South Korea’s Ministry of Food and Drug Safety (MFDS) on July 17. The approval allows Opdivo® (nivolumab) Intravenous Infusion, an anti-PD-1 antibody, to be used in combination with cisplatin and gemcitabine for the first-line treatment of patients with unresectable or metastatic urothelial carcinoma.
This approval is based on the Phase 3 CheckMate -901 study, which compared Opdivo in combination with cisplatin and gemcitabine followed by Opdivo monotherapy to cisplatin-gemcitabine alone. Results showed that the Opdivo regimen significantly improved overall survival (OS) and progression-free survival (PFS) compared to chemotherapy alone, with no new safety concerns identified.
Opdivo monotherapy was previously approved in South Korea for treating locally advanced or metastatic urothelial carcinoma that progressed on platinum-based chemotherapy in August 2017, and for adjuvant treatment in high-risk muscle-invasive bladder carcinoma in February 2022.
About CheckMate -901 Study CheckMate -901 is a randomized, open-label Phase 3 study evaluating Opdivo combined with Yervoy® (ipilimumab) or cisplatin and gemcitabine, followed by Opdivo monotherapy. The study aims to assess the efficacy of these combinations compared to cisplatin-gemcitabine alone in previously untreated unresectable or metastatic urothelial carcinoma. The primary endpoints are overall survival (OS) and progression-free survival (PFS).
About Urothelial Carcinoma Bladder cancer is the ninth most common cancer globally, with over 610,000 new cases in 2022 and more than 220,000 deaths annually. Urothelial carcinoma, the most common type of bladder cancer, can also occur in other parts of the urinary tract. Despite early-stage diagnosis, recurrence and progression rates are high, with a poor prognosis for metastatic disease.
About Opdivo Opdivo is a PD-1 immune checkpoint inhibitor designed to enhance the body’s immune response against tumors by blocking the PD-1/ligand interaction. Since its approval for melanoma in Japan in July 2014, Opdivo has become a key treatment for multiple cancers and is approved in over 65 countries.
About Ono and Bristol Myers Squibb Collaboration Ono and Bristol Myers Squibb (BMS) established a collaboration in 2011, granting BMS global rights for Opdivo except in Japan, South Korea, and Taiwan. The partnership was expanded in July 2014 to include joint development and commercialization of multiple immunotherapies for cancer.
