Opdivo® (Nivolumab) Intravenous Infusion Approved for First–Line Treatment of Advanced or Recurrent Non-Small Cell Lung Cancer in Combination Therapy in Taiwan
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 the approval of Opdivo® (nivolumab) Intravenous Infusion 20 mg, 100 mg Inj. ("Opdivo"), a human anti-human PD-1 monoclonal antibody, on February 25, from the Taiwan Food and Drug Administration (TFDA) in Taiwan for additional indication of the first-line treatment of advanced or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations, in the following combination therapies:
1) Combination therapy with Opdivo and Yervoy* (tumors express PD-L1 ≧1%)
2) Combination therapy with Opdivo, Yervoy plus 2 cycles platinum-based chemotherapy
* : YERVOY® (generic name: ipilimumab) Injection is a human monoclonal antibody against cytotoxic T-lymphocyte-associated antigen 4（CTLA-4）
These approvals are based on the results from the following clinical studies conducted by ONO and Bristol Myers Squibb (NYSE: BMY; “BMS”):
Above 1): CheckMate -227 Study (Part 1a): a global, multi-center, multi-part, randomized, open-label Phase III study evaluating Opdivo, or Opdivo plus Yervoy compared to platinum-doublet chemotherapy in patients, whose tumors express PD-L1 ≧1%, with previously untreated unresectable advanced or recurrent non-small cell lung cancer (NSCLC)
Above 2): CheckMate -9LA Study: a global, multi-center, randomized, open-label Phase III study evaluating Opdivo plus Yervoy in combination with platinum-doublet chemotherapy (two cycles) compared to platinum-doublet chemotherapy alone in patients with previously untreated unresectable advanced or recurrent NSCLC
About CheckMate -227 study
This study is a global, multi-center, multi-part, randomized, open-label Phase III clinical study, evaluating Opdivo, or Opdivo plus Yervoy, or Opdivo plus platinum-doublet chemotherapy compared to platinum-doublet chemotherapy in patients with previously untreated unresectable advanced or recurrent NSCLC. This study consists of the following three Parts:
- Part 1a: Evaluating the efficacy and safety of Opdivo, or Opdivo plus Yervoy in patients whose tumors express PD-L1 ≧1%
- Part 1b: Evaluating the efficacy and safety of Opdivo plus Yervoy, or Opdivo plus platinum-doublet chemotherapy in patients whose tumors express PD-L1 <1%
- Part 2: Evaluating the efficacy and safety of Opdivo plus platinum-doublet chemotherapy, regardless of PD-L1 expression level
In the Opdivo and Yervoy combination therapy arm of Part 1, patients received Opdivo 3 mg/kg every 2 weeks plus Yervoy 1 mg/kg every 6 weeks for up to 24 months, until disease progression or onset of unacceptable toxicity is observed. In Part 1a, one of the primary endpoints was overall survival (OS) in patients whose tumors expressed PD-L1 ≧1%.
About CheckMate -9LA study
CheckMate -9LA study is a global, multi-center, randomized, open-label Phase III clinical study evaluating Opdivo (360 mg Q3W) plus Yervoy (1 mg/kg Q6W) in combination with platinum-doublet chemotherapy (two cycles Q3W) compared to platinum-doublet chemotherapy alone in patients with previously untreated unresectable advanced or recurrent NSCLC, regardless of PD-L1 expression and histology. Patients in the combination treatment arm were treated for up to 24 months with Opdivo and Yervoy or until disease progression or unacceptable toxicity. Patients in the control arm were treated with up to four cycles of chemotherapy and optional pemetrexed maintenance (if eligible) until disease progression or toxicity. The primary endpoint of the study was OS in the intent to treat (ITT) population. Secondary endpoints were progression-free survival (PFS), overall response rate (ORR), and efficacy measures according to biomarkers.
About Lung Cancer
Lung cancer is considered to be a form of malignant tumor that arises from cells in the trachea, bronchi and alveoli. Lung cancer is divided into two types, small cell lung cancer and non-small cell lung cancer (NSCLC), depending on the broad histological subtypes. NSCLC is one of the most common types of lung cancer, accounting for about 80-85% of lung cancer (1). NSCLC is further classified into adenocarcinoma (about 40% of lung cancer), squamous cell carcinoma (about 25%) and large cell carcinoma (about 10%) (2). About 16,000 new cases of lung cancer are diagnosed per year in Taiwan (3). It is estimated that approximately 9,000 deaths result from the disease per year in Taiwan (3), making lung cancer the first leading cause of cancer-related deaths. Survival rates vary depending on the stage and type of the cancer when diagnosed. For patients diagnosed with metastatic lung cancer, the five-year survival rate is about 5%.
OPTW is committed to taking measures necessary for proper use of Opdivo by collecting clinical data on the safety and efficacy of Opdivo. In Taiwan, OPTW and Bristol Myers Squibb (Taiwan) Ltd. have co-promoted the sales of Opdivo, based on the strategic collaboration agreement made between ONO and BMS in July 2014.
- American Cancer Society; What Is Non-Small Cell Lung Cancer?： https://www.cancer.org/content/cancer/en/cancer/lung-cancer/about/what-is.html
- Non-Small Cell Lung Cancer Treatment (PDQ®)–Health Professional Version, National Cancer Institute: https://www.cancer.gov/types/lung/hp/non-small-cell-lung-treatment-pdq#_12_toc
- Cancer Registry Annual Report, 2018 Taiwan
Outline of Opdivo® Intravenous Infusion 20 mg, 100 mg
|Product name||Opdivo® Intravenous Infusion 20 mg, 100 mg|
|Generic name (INN)||Nivolumab|
|Dosage and administration||
< monotherapy >
< combination therapy >
*: Unless otherwise described, Opdivo and ipilimumab should be infused intravenously over 30 minutes.
|Approval date||February 25, 2021|
|Manufacturer||Ono Pharmaceutical Co., Ltd.|
|Importer/distributor||Ono Pharma Taiwan Co., Ltd.|
|Distribution collaboration||Bristol Myers Squibb (Taiwan) Ltd.|
* Underline shows the revised parts according to this approval
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.
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 is conducting clinical development program including esophago-gastric junction cancer, hepatocellular carcinoma, urothelial cancer, 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.