Bristol Myers Squibb’s Opdivo + Yervoy Dual Immunotherapy Approved in China for First-Line Treatment of Unresectable Non-Epithelioid Malignant Pleural Mesothelioma

On June 10, according to the official website of China's National Medical Products Administration (NMPA), Bristol-Myers Squibb's immunotherapy combination has been approved for marketing in China for the treatment of adult patients with treatment-naïve, unresectable, non-epithelioid malignant pleural mesothelioma. Previously, the marketing application for this combination therapy (JXSS2000056/JXSS2000054) was granted priority review by the Center for Drug Evaluation (CDE).

The Phase 3 CheckMate-743 clinical trial demonstrated that nivolumab injection in combination with ipilimumab significantly improves overall survival (OS) in previously untreated patients with unresectable malignant pleural mesothelioma. At a minimum follow-up of 22 months, nivolumab in combination with ipilimumab reduced the risk of death by 26%, with a median OS of 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 was 41% in the nivolumab plus ipilimumab group, compared to 27% in the chemotherapy group.

About Malignant Pleural Mesothelioma

Malignant pleural mesothelioma is a rare and highly aggressive malignancy that grows along the outer lining of the lungs, and its occurrence is strongly associated with asbestos exposure. Due to delayed diagnosis, most patients present with advanced or metastatic disease at the time of diagnosis. The prognosis for malignant pleural mesothelioma is generally poor; historically, the median survival for untreated patients with advanced or metastatic disease is less than one year, with a five-year survival rate of approximately 10%.

About Nivolumab Injection

Nivolumab is a PD-1 immune checkpoint inhibitor that uniquely harnesses the body's own immune system to help restore anti-tumor immune responses. This characteristic of leveraging the body's own immune system to combat cancer has established nivolumab as an important treatment option for multiple tumor types.

In July 2014, nivolumab became the first PD-1 immune checkpoint inhibitor to receive regulatory approval globally. To date, nivolumab has been approved in over 65 regions, including the United States, the European Union, Japan, and China. In October 2015, the combination of nivolumab and ipilimumab injection for the treatment of melanoma became the first immuno-oncology (I-O) combination therapy to receive regulatory approval. It has since been approved in more than 50 regions, including the United States and the European Union.

# About Ipilimumab

Ipilimumab is a recombinant humanized monoclonal antibody that binds to cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activation. Following binding to CTLA-4, ipilimumab blocks the interaction between CTLA-4 and its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to enhance T-cell activation and proliferation, including that of tumor-infiltrating effector T cells. Inhibition of CTLA-4 signaling may also attenuate regulatory T-cell function, which may contribute to an overall enhancement of T-cell responses, including anti-tumor immune responses. On March 25, 2011, the U.S. Food and Drug Administration (FDA) approved ipilimumab (3 mg/kg) monotherapy for the treatment of 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 undergoing an extensive development program spanning multiple tumor types.

The dual immune checkpoint inhibitor combination therapy of nivolumab and ipilimumab (Opdivo + Yervoy) was approved in October 2015, becoming the first immuno-oncology drug combination regimen globally to receive regulatory approval. This dual checkpoint inhibitor combination therapy is believed to exert a potentially synergistic mechanism of action: ipilimumab facilitates T cell activation and proliferation, while nivolumab enhances the ability of existing T cells to recognize tumors. Certain T cells activated by ipilimumab can differentiate into memory T cells, thereby holding the promise of eliciting a durable immune response. This recent approval in China is expected to provide patients with additional treatment options.

Responsible Editor: Liuli

Disclaimer: This article consists of compiled content from Yaozhi.com. The copyright belongs to the original author(s). It is shared solely for the purpose of disseminating information and does not represent the views of this platform. Should any issues arise concerning the content, copyright, or other matters, please contact us by leaving a message on this website, and we will promptly remove the content.