China News Service, Guangzhou, September 16 (Cai Minjie, Chen Qiuyan) Sun Yat-sen University Cancer Center said on the 16th that the first-line treatment of relapsed/metastatic nasopharyngeal carcinoma led by the director and dean of the center, Professor Ruihua Xu The research (JUPITER-02 research) results were recently published in the top international journal "Nature-Medical" in the form of cover recommendation.
Professor Ruihua Xu is the corresponding author of this article, and Professor Haiqiang Mai and Professor Qiuyan Chen from Sun Yat-sen University Cancer Center are the co-first authors.
Nasopharyngeal carcinoma is a highly aggressive malignant tumor, especially for patients with recurrent/metastatic nasopharyngeal carcinoma. The results of the JUPITER-02 study show that compared with chemotherapy alone, teriprizumab combined with chemotherapy is the first-line treatment for advanced stage Patients with nasopharyngeal cancer have shown longer survival benefits, and are safe and well tolerated. It is expected to rewrite the global first-line treatment standard for recurrent/metastatic nasopharyngeal cancer.
Nasopharyngeal carcinoma is a malignant tumor originating in the mucosal epithelium of the nasopharyngeal area. It has obvious regional characteristics. It is especially high in southern China (such as Guangdong and Guangxi) and Southeast Asia. It is called "Cantonese cancer" internationally.
At the beginning of the research design, Xu Ruihua considered the latest research results and China’s national conditions in the selection of treatment options, and chose gemcitabine combined with cisplatin (GP) chemotherapy with better efficacy, higher safety, and economical benefits as the control group. GP The program has clear evidence for initial treatment of nasopharyngeal carcinoma and recurrence and metastasis of nasopharyngeal carcinoma.
From November 2018 to October 2019, a total of 289 patients were enrolled in the study, and they were randomized 1:1 into the teriprizumab combined chemotherapy group or the placebo combined chemotherapy group.
The results showed that the progression-free survival of the teriprizumab combined with chemotherapy group improved. The median progression-free survival was 11.7 months, which was 3.7 months higher than that of the placebo group, which prolonged the progression-free survival time of patients.
At present, the benefit trend of overall survival in the triprolizumab group has been observed, the risk of death has been reduced by 40%, and the overall safety of the study is well tolerated and manageable.
Xu Ruihua said that the first-line treatment of relapsed/metastatic nasopharyngeal carcinoma with teriprizumab combined with GP chemotherapy is expected to rewrite the global treatment standard.
According to reports, in March 2021, based on the breakthrough therapy designation granted by the U.S. Food and Drug Administration (FDA), Junshi Bio announced the rolling submission to the FDA of biological products for the treatment of relapsed or metastatic nasopharyngeal carcinoma. In the licensing application, Teriplimumab became the first Chinese-made anti-PD-1 monoclonal antibody to submit a marketing application to the U.S. FDA. Recently, the FDA granted the second breakthrough therapy designation for teriprizumab based on the clinical evidence from the JUPITER-02 study. On September 1, Junshi Bio announced that the company has completed the rolling submission of teriprizumab to the FDA Combining gemcitabine/cisplatin as the first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma, and a single-drug application for the second-line and above treatment of recurrent or metastatic nasopharyngeal carcinoma after platinum-containing chemotherapy. (over)