ONO Submits Supplemental Application for Opdivo in Japan to Expand Its Use for Treatment of Malignant Mesothelioma

Ono Pharmaceutical Co.,Ltd. (Osaka, Japan; President and CEO, Gyo Sagara; ‘ONO’) announced today that it has submitted an addendum for Opdivo (generic name: nivolumab) intravenous infusion (‘Opdivo’), a human anti-human PD -1 monoclonal antibody in Japan to expand its use for the treatment of malignant mesothelioma (excluding malignant pleural mesothelioma) for a partial amendment of the approved articles of the manufacturing and marketing authorization.

This application is based on the results of the investigator-initiated Phase 2 clinical study (VIOLA study: HCM-002) conducted under the direction of Hyogo Medical University Hospital in patients with malignant mesothelioma (excluding malignant pleural mesothelioma).

In malignant mesothelioma, Opdivo monotherapy and Opdivo combination therapy with Yervoy (generic name: ipilimumab) were approved in Japan for the treatment of pleural mesothelioma in August 2018 and May 2021, respectively. On the other hand, there are no drugs approved in Japan or abroad for the treatment of malignant mesothelioma other than malignant pleural mesothelioma. Since no standard treatment has yet been established, drug development is urgently needed.

Opdivo was designated as an orphan medicinal product for the indication malignant mesothelioma (excluding malignant pleural mesothelioma) on February 22, 2023 and was approved for priority review by the Ministry of Health, Labor and Welfare (MHLW).

About VIOLA Trial

The VIOLA study is an investigator-initiated, multi-center, open-label, non-comparative Phase 2 study to evaluate the efficacy and safety of Opdivo in treatment-na├»ve or previously treated with chemotherapy patients with malignant mesothelioma (excluding malignant pleural mesothelioma). Patients received Opdivo 240 mg every two weeks. The primary endpoint of the study is objective response rate (central assessment). Secondary endpoints include objective response rate (physician’s assessment of the medical facility), disease control rate (DCR), overall survival (OS), and progression-free survival (PFS).

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About malignant mesothelioma

Malignant mesothelioma is a malignant tumor arising from undifferentiated mesenchymal cells of the mesothelium that covers the surface of the body cavity and underlying connective tissue in the thoracic cavity, pericardial cavity, abdominal cavity and tunica vaginalis testicular cavity, and is classified into malignant pleural mesothelioma, malignant pericardial mesothelioma, malignant Peritoneal mesothelioma and malignant mesothelioma of the tunica vaginalis testis depending on the site of occurrence.

It is estimated that there are 2,283 patients with malignant mesothelioma per year1) in Japan. It is reported that in 2020 in Japan2) 1,605 deaths per year are due to the disease. The proportion of patients with malignant mesothelioma by location is given as 85.5% for malignant pleural mesothelioma, 13.2% for malignant peritoneal mesothelioma, 0.8% for malignant pericardium mesothelioma and 0.5% for malignant mesothelioma of the tunica vaginalis testis3).

Malignant mesothelioma is a disease with a poor prognosis, with median and mean overall survival being 7.7 months4) and 8.6 months5), respectively, and 3-year and 5-year survival rates being 18.6% and 9.9%, respectively. 6) amount to .

Globocan 2020: Japan, World Health Organization. Available at: https://gco.iarc.fr/today/data/factsheets/populations/392-japan-fact-sheets.pdf

Annual changes in the number of mesothelioma deaths by prefecture (1995-2020), Annual Population Statistics Report (fixed number), Department of Health, Labor and Welfare

Gemba K et al. Cancer Science, 2012; 103(3):483-90.

Gemba K et al. Acta Oncologica. 2013; 52:803-8.

Solomons KS Afr Med J. 1984; 66:407-12.

Cancer Survival Rates at the Japanese Association of Clinical Cancer Centers (November 2021)

About Opdivo

Opdivo is a programmed immune checkpoint inhibitor (PD-1) designed to uniquely utilize the body’s immune system to restore the anti-tumor immune response by blocking the interaction between PD-1 and its ligands . By harnessing the body’s immune system to fight cancer, Opdivo has become an important treatment option for multiple cancers since its approval for the treatment of melanoma in Japan in July 2014. Opdivo is currently approved in more than 65 countries, including Japan and South Korea, Taiwan, China, the United States and the European Union.

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In Japan, ONO launched Opdivo in September 2014 for the treatment of unresectable melanoma. Thereafter, Opdivo received approval in December 2015 for additional indications in unresectable, advanced or recurrent non-small cell lung cancer and in August 2016 in unresectable or metastatic renal cell carcinoma, recurrent or refractory classical Hodgkin’s lymphoma in December 2016, recurrent or metastatic head and neck Cervical cancer in March 2017, unresectable advanced or recurrent gastric cancer that progressed after chemotherapy in September 2017, unresectable advanced or recurrent malignant pleural mesothelioma that progressed after chemotherapy August 2018, Microsatellite Instability High (MSI-High) unresectable advanced or recurrent Colorectal cancer that has progressed after chemotherapy and unresectable advanced or recurrent esophageal cancer that has progressed after chemotherapy February 2020, cancer with un known primary tumor in December 2021 and adjuvant treatment of urothelial kidney cancer in March 2022.

In addition, ONO is conducting clinical development program, including hepatocellular carcinoma, ovarian cancer, prostate cancer, etc.

About the collaboration between ONO and Bristol Myers Squibb

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


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