Ono Pharmaceutical Co., Ltd. (Osaka, Japan; President, Representative Director, Gyo Sagara; “ONO”) announced that Ono Pharma Taiwan Co., Ltd. (“OPTW”), a Taiwanese subsidiary of ONO, received approval for Opdivo® (nivolumab) Intravenous Infusion 20 mg, 100 mg Inj. ("Opdivo"), a human anti-PD-1 monoclonal antibody on September 3, 2021 from the Taiwan Food and Drug Administration (TFDA) in Taiwan to expand its use for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma, in combination with Yervoy® (ipilimumab) ^*.

• Yervoy is a human anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) monoclonal antibody.

　This approval is based on results of the pre-planned interim analysis from a global multi-center, randomized, open-label Phase 3 clinical study (CheckMate -743 study), evaluating Opdivo plus Yervoy combination treatment, compared to standard of care platinum-based chemotherapy, in patients with previously untreated unresectable malignant pleural mesothelioma. In this analysis, Opdivo plus Yervoy demonstrated a significant improvement in overall survival (OS), the primary endpoint, versus chemotherapy. The safety profile of Opdivo plus Yervoy observed in this study was consistent with those previously reported in studies of the combination treatment.

About CheckMate -743 study

　CheckMate -743 is a global multi-center, randomized, open-label Phase 3 clinical study, evaluating Opdivo plus Yervoy combination treatment compared to chemotherapy (combination treatment of pemetrexed and either cisplatin or carboplatin) in patients (n=605) with previously untreated unresectable malignant pleural mesothelioma. In this study, 303 patients were randomized to receive Opdivo 3 mg/kg every two weeks and Yervoy 1 mg/kg every six weeks for up to 24 months or until disease progression or unacceptable toxicity, and 302 patients were randomized to receive cisplatin 75 mg/㎡ or carboplatin AUC 5 plus pemetrexed 500 mg/㎡ in 21-day cycles for six cycles or until disease progression or unacceptable toxicity. The primary endpoint of the study was OS in all randomized patients. Key secondary endpoints were objective response rate (ORR), disease control rate (DCR) and progression-free survival (PFS).

About malignant pleural mesothelioma

　Malignant pleural mesothelioma (MPM) is a malignant tumor derived from undifferentiated mesenchymal cells of the mesothelium covering the thoracic surface and its underlying connective tissue. It is known that the cause of its occurrence is highly related to asbestos inhaled into the body in occupational or living environment and that MPM develops after a period of about 30 to 50 years following asbestos exposure. MPM is an aggressive cancer, which diagnosis is often delayed, with the majority of patients presenting with advanced or metastatic disease. The standard of care treatment for MPM is combination therapy of pemetrexed and cisplatin. The unmet need remains for long-term survival and durable benefit for first-line unresectable MPM patients. This approval is expected to allow Opdivo plus Yervoy combination treatment to become a new treatment option for this patient population in Taiwan.

About Opdivo

　Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response by blocking the interaction between PD-1 and its ligands. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers since the approval for the treatment of melanoma in Japan in July 2014. Opdivo is currently approved in more than 65 countries, including Japan, South Korea, Taiwan, China, the US and European Union.
　In Japan, ONO launched Opdivo for the treatment of unresectable melanoma in September 2014. Thereafter, Opdivo received an approval for additional indications of unresectable, advanced or recurrent non-small cell lung cancer in December 2015, unresectable or metastatic renal cell carcinoma in August 2016, relapsed or refractory classical Hodgkin lymphoma in December 2016, recurrent or metastatic head and neck cancer in March 2017, unresectable advanced or recurrent gastric cancer which has progressed after chemotherapy in September 2017, unresectable advanced or recurrent malignant pleural mesothelioma which has progressed after chemotherapy in August 2018, and microsatellite instability high (MSI-High) unresectable advanced or recurrent colorectal cancer that has progressed following chemotherapy and unresectable advanced or recurrent esophageal cancer that has progressed following chemotherapy in February 2020.
　In addition, ONO has submitted supplemental applications for the adjuvant treatment of urothelial cancer and cancer of unknown primary, and is conducting clinical development program including hepatocellular carcinoma, ovarian cancer, bladder cancer, prostate cancer, pancreatic cancer, biliary tract cancer, etc.

About ONO and Bristol Myers Squibb Collaboration

　In 2011, through a collaboration agreement with Bristol Myers Squibb (BMS), ONO granted BMS its territorial rights to develop and commercialize Opdivo globally except in Japan, South Korea and Taiwan, where ONO had retained all rights to Opdivo except the US at the time. In July 2014, ONO and BMS further expanded their strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies – as single agent and combination regimens – for patients with cancer in Japan, South Korea and Taiwan.

About Ono Pharma Taiwan Co., Ltd.

　Ono Pharma Taiwan Co., Ltd. (OPTW), in Taipei, Taiwan, was established as an ONO’s wholly-owned subsidiary in December 2014. OPTW has marketed specialty products such as anti-cancer agent, including Opdivo. OPTW is committed to developing and marketing its products created internally for further penetration into the Taiwanese market.