First-line dual immunotherapy for pleural mesothelioma! Bristol-Myers Squibb's immune combination therapy approved in China

June 11, 2021

On June 10, according to the official website of the National Medical Products Administration (NMPA) of China, Bristol-Myers Squibb's immune combination therapy was approved for marketing in China for the treatment of unresectable non-epithelial malignant pleural mesothelioma Adult patients. Previously, the proposed marketing application (JXSS2000056/JXSS2000054) of the combination therapy was included in the priority review by the Center for Drug Evaluation (CDE).

A phase 3 clinical study called CheckMate-743 confirmed that nivolumab injection combined with ipilimumab can significantly improve the overall survival of patients with previously untreated, unresectable malignant pleural mesothelioma ( OS). At the shortest follow-up of 22 months, nivolumab combined with ipilimumab reduced the patient’s risk of death by 26%. The patient’s median OS was 18.1 months, compared to 14.1 months in the chemotherapy group (hazard ratio [HR]: 0.74 [96.6% confidence interval]: 0.60, 0.91; p=0.002). The 2-year survival rate of patients in the nivolumab combined with ipilimumab group was 41%, compared with 27% in the chemotherapy group.

About malignant pleural mesothelioma

Malignant pleural mesothelioma is a rare and highly aggressive malignant tumor that grows along the outside of the lung. Its incidence is highly correlated with asbestos exposure. Most patients are delayed in diagnosis, and the disease has progressed or metastasis has occurred at the time of diagnosis. The prognosis of malignant pleural mesothelioma is generally poor. The median survival time of patients with untreated advanced or metastatic malignant pleural mesothelioma is less than one year, and the five-year survival rate is about 10%.

About Nivolumab Injection

Nivolumab is a PD-1 immune checkpoint inhibitor, which can help the body restore the anti-tumor immune response by using the body's own immune system. In July 2014, Nivolumab became the world's first PD-1 immune checkpoint inhibitor approved by regulatory agencies. At present, Nivolumab has been approved in more than 65 regions, including the United States, the European Union, Japan and China. In October 2015, the combination of nivolumumab and ipilimumab injection for the treatment of melanoma became the first immuno-oncology (IO) drug combination therapy approved by the regulatory agency. It has been approved in more than 50 regions, including The United States and the European Union. In China, nivolumab was first approved for marketing in 2018, and currently approved indications in China include patients with non-small cell lung cancer, head and neck squamous cell carcinoma, and gastroesophageal junction adenocarcinoma.

About ipilimumab

Ipilimumab is a recombinant humanized monoclonal antibody that can bind to cytotoxic T lymphocyte-associated antigen 4 (CTLA-4). On March 25, 2011, the U.S. Food and Drug Administration (FDA) approved ipilimumab (3 mg/kg) as a monotherapy for patients with unresectable or metastatic melanoma. Currently, ipilimumab has been approved in more than 50 countries for the treatment of unresectable or metastatic melanoma. Ipilimumab is undertaking an extensive development program covering multiple tumor types. According to public information, this approval is the first approval of the drug in China. Nivolumab and Ipilimumab (Opdivo+Yervoy), a dual checkpoint inhibitor combination therapy, was approved in October 2015 and became the world's first immuno-oncology drug combination therapy approved by regulatory agencies. This dual checkpoint inhibitor combination therapy is believed to have a potential synergistic mechanism: ipilimumab helps activate and proliferate T cells, while nivolumab helps existing T cells find tumors. Some T cells activated by ipilimumab can differentiate into memory T cells, which is expected to achieve a long-term immune response. This approval in China is expected to bring more treatment options to patients.

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