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Ono Pharmaceutical Co., Ltd (Headquarters: Osaka, Japan; President and COO: Toichi Takino; “Ono”) today announced that Ono Pharma Taiwan Co., Ltd. (Taipei, Taiwan; “OPTW”), a Taiwanese subsidiary of Ono, received the additional approval of Opdivo® (generic name: nivolumab) Intravenous Infusion ("Opdivo"), an anti-PD-1 antibody, on January 14 from the Taiwan Food and Drug Administration (TFDA) in Taiwan, in combination with ipilimumab, for the treatment of adult patients with unresectable or metastatic microsatellite instability-high (MSI-High) or mismatch repair deficient (dMMR) colorectal cancer (CRC).
This approval is based on the results from the CheckMate-8HW study, a global multi-center Phase 3 clinical study (CA209-8HW: ONO-4538-87), evaluating Opdivo plus Yervoy compared to Opdivo alone or investigator’s choice of chemotherapy* in patients with unresectable or metastatic MSI-High or dMMR CRC. In this study, Opdivo plus Yervoy demonstrated a clinically meaningful improvement in one of the dual primary endpoints of progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR) compared to investigator’s choice of chemotherapy in previously untreated patients with centrally confirmed MSI-High or dMMR CRC at a pre-specified interim analysis. In addition, Opdivo plus Yervoy demonstrated a clinically meaningful improvement in another primary endpoint of PFS assessed by BICR, compared to Opdivo alone in patients across all lines of treatment. The safety profile of Opdivo plus Yervoy remained consistent with previously reported data, with no new safety signals identified.
*: Any one of the following regimens was selected: mFOLFOX6 (5-fluorouracil, folinic acid, and oxaliplatin), mFOLFOX6 with bevacizumab or cetuximab, FOLFIRI (5-fluorouracil, folinic acid, and irinotecan), or FOLFIRI with bevacizumab or cetuximab.
Opdivo as a single agent, or in combination with Yervoy, was previously granted accelerated approval in MSI-High/dMMR CRC adult patients that has progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan. Today’s TFDA decision converts this second-line indication to full approval for Opdivo monotherapy, and expands the indication for Opdivo plus Yervoy into the first-line setting based on the CheckMate-8HW study.
About CheckMate-8HW Study (CA209-8HW: ONO-4538-87)
CheckMate-8HW study is a global multi-center, randomized, open-label Phase III clinical study evaluating Opdivo plus Yervoy compared to Opdivo alone or investigator’s choice of chemotherapy (mFOLFOX6 or FOLFIRI with or without bevacizumab or cetuximab) in patients with unresectable or metastatic MSI-High or dMMR CRC.
Approximately 830 patients were randomized to receive Opdivo plus Yervoy (Opdivo 240 mg plus Yervoy 1 mg/kg Q3W for four doses, followed by Opdivo 480 mg Q4W), Opdivo monotherapy (Opdivo 240 mg Q2W for six doses, followed by Opdivo 480 mg Q4W), or investigator’s choice of chemotherapy. Patients were treated until disease progression or unacceptable toxic effects. The dual primary endpoints of the study are PFS per BICR for Opdivo plus Yervoy compared to investigator’s choice of chemotherapy in previously untreated patients with centrally confirmed MSI-High or dMMR CRC, and PFS per BICR for Opdivo plus Yervoy compared to Opdivo alone in patients across all lines of therapy.
About Colorectal Cancer (CRC)
CRC is the third most common cancer, with approximately 1,926, 000 new cases diagnosed each year worldwide, and approximately 904,000 deaths are reported annually1). In Taiwan, CRC is the most common cancer, with approximately 22,000 new cases per year, and approximately 7,000 deaths are reported each year2).
Approximately 4% of unresectable CRC patients have MSI-High or dMMR tumors3). For unresectable advanced or recurrent MSI-High or dMMR CRC, conventional chemotherapy has not been effective enough, and the development of new therapeutic drugs is expected.
1. Globocan 2022. Available at: gco.iarc.fr/today/en/fact-sheets-populations
2. Taiwan Cancer Registry Annual Report 2022
3. Front Oncol. 2021;11:764912. Published 2021 Nov 15. Doi:10.3389/fonc.2021.764912
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, 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, MSI-High unresectable advanced or recurrent CRC that has progressed following chemotherapy and unresectable advanced or recurrent esophageal cancer that has progressed following chemotherapy in February 2020, cancer of unknown primary in December 2021, adjuvant treatment of urothelial carcinoma in March 2022, malignant mesothelioma (excluding malignant pleural mesothelioma) in November 2023, unresectable advanced or recurrent malignant epithelial tumors in February 2024, and unresectable hepatocellular carcinoma in June 2025.
About Yervoy
Yervoy is a recombinant, human monoclonal antibody, and binds to the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activation. Yervoy binds to CTLA-4, and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation, including the activation and proliferation of tumor infiltrating T-effector cells. Inhibition of CTLA-4 signaling can also reduce T-regulatory cell function, which may contribute to a general increase in T-cell responsiveness, including anti-tumor immune response. On March 25, 2011, the U.S. Food and Drug Administration (FDA) approved Yervoy 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma. Yervoy is now approved in more than 50 countries. There is a broad, ongoing development program in place for Yervoy spanning multiple tumor types. In Japan, Yervoy was approved for the indication of unresectable malignant melanoma in July 2015.
About the Ono and Bristol Myers Squibb Collaboration
In 2011, through a collaboration agreement with Bristol Myers Squibb (BMS) (bms.com), Ono (ono-pharma.com) 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 the companies’ 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 (OPTW)
OPTW is an Ono’s wholly-owned subsidiary established in in December 2014. OPTW has marketed Opdivo, an anti-PD-1 antibody/anti-neoplastic drug in Taiwan since 2016. OPTW is committed to bringing more innovative new products to meet unmet medical needs to patients in Taiwan as soon as possible.
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