Ono Pharmaceutical Co., Ltd. – Opdivo intravenous infusion approved for adjuvant treatment of esophageal cancer or gastroesophageal junction cancer in Taiwan

Ono Pharmaceutical Co., Ltd. (Osaka, Japan; Chairman, Deputy Director, Gyo Sagara; ‘ONO’) announced that Ono Pharma Taiwan Co., Ltd. (“OPTW”), a Taiwanese subsidiary of ONO, has received additional approval from Opdivo (nivolumab) Intravenous Infusion 20 mg, 100 mg Inj. (“Opdivo”), a human anti-human PD-1 monoclonal antibody, on December 29, 2021 in Taiwan from Taiwan Food and Drug Administration (TFDA) for the adjuvant treatment of patients with completely resected esophageal cancer or gastroesophageal junction cancer with residual pathologic disease who have received concomitant neoadjuvant chemoradiotherapy.

This approval is based on the result of a global, multicenter, randomized, double-blind, phase 3 clinical study, Study CheckMate -577 (ONO-4538-43), evaluating Opdivo as monotherapy as adjuvant therapy in patients with d ‘resected esophageal cancer or cancer of the gastroesophageal junction, compared to placebo. In this study, Opdivo showed a statistically significant improvement in disease-free survival (DFS), the primary endpoint of the study, compared to placebo. The safety profile of Opdivo in this study was consistent with previously reported studies of Opdivo as monotherapy.

About the CheckMate -577 study (ONO-4538-43)

The CheckMate -577 study is a global, multicenter, randomized, double-blind, phase 3 clinical study evaluating Opdivo as monotherapy as adjuvant therapy in patients with resected esophageal cancer (ESC) or cancer of the gastroesophageal junction (CJGE) who received neoadjuvant radiochemotherapy (CRT) and did not obtain a complete pathological response. After neoadjuvant CRT and complete surgical resection of the tumor (also known as trimodal therapy), patients were randomized to receive Opdivo or placebo. In patients receiving Opdivo, it was given 240 mg every two weeks for 16 weeks, followed by Opdivo 480 mg every four weeks until disease recurrence, unacceptable toxicity or withdrawal of consent, with maximum total treatment time of one year. The primary endpoint of the study is disease-free survival (SSM) and the secondary endpoint is overall survival (OS).

About cancer of the esophagus and cancer of the gastroesophageal junction

Esophageal cancer (ESC) is a malignant tumor that occurs in the inner layer (lining) of the esophagus and grows outside (towards the deeper layer). There are two main histological types of CSE; Squamous cell carcinoma (SCC) and adenocarcinoma. SCC is the predominant type accounting for about 90% of all ESCs in Taiwan. It is estimated that approximately 2,800 new cases 1) are diagnosed with ESC per year in Taiwan and about 1,900 deaths 1) per year from this disease. Gastroesophageal junction cancer (GEJC) is a malignant tumor that occurs in the area of ​​the body that connects the lower part of the esophagus to the stomach 2).?

Cancer Registry Annual Report, 2018 Taiwan

American Cancer Society. What is esophageal cancer?

About Opdivo

Opdivo is a programmed death immune checkpoint-1 (PD-1) inhibitor designed to uniquely harness the body’s own immune system to help 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 several cancers since the approval of melanoma treatment in Japan in july 2014. Opdivo is currently approved in more than 65 countries, including Japan, South Korea, Taiwan, China, the we and European Union.

In Japan, ONO launched Opdivo for the treatment of unresectable melanoma in september 2014. Subsequently, Opdivo received 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 classic Hodgkin lymphoma in december 2016, recurrent or metastatic head and neck cancer in march 2017, advanced or recurrent unresectable gastric cancer that has progressed after chemotherapy in september 2017, unresectable advanced or recurrent malignant pleural mesothelioma that has progressed after chemotherapy in august 2018, and advanced or recurrent unresectable microsatellite instability (MSI-High) colorectal cancer that has progressed after chemotherapy and advanced or recurrent unresectable esophageal cancer that has progressed after chemotherapy in February 2020, and cancer of unknown primary in december 2021.

In addition, ONO has submitted an additional application for adjuvant treatment of urothelial cancer and is conducting a clinical development program including hepatocellular carcinoma, ovarian cancer, bladder cancer, prostate cancer, cancer of the pancreas, cancer of the bile ducts, etc.

About the ONO and Bristol Myers Squibb collaboration

In 2011, thanks to a collaboration agreement with Bristol Myers Squibb (BMS), ONO has granted BMS its territorial rights to develop and market Opdivo globally, except in Japan, South Korea and Taiwan, where ONO had retained all rights to Opdivo with the exception of the United States at the time. In july 2014, ONO and BMS have further expanded their strategic collaboration agreement to jointly develop and market several immunotherapies – in monotherapy and in combination – for cancer patients in Japan, South Korea and Taiwan.

On Ono Pharma Taiwan Co., Ltd.

Ono Pharma Taiwan Co., Ltd. (Taipei, Taiwan, “OPTW”) is a 100% subsidiary of ONO established in december 2014. OPTW has established its own sales organization in Taiwan and has marketed Opdivo, an anti-PD-1 antibody / anti-neoplastic drug since 2016. OPTW is committed to providing new, more innovative products to meet the unmet medical needs of patients in Taiwan as soon as possible.

Contact:

ONO PHARMACEUTICAL CO., LTD.

Business communication

E: public_relations@ono.co.jp

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