On November 29, 2021, Junshi Biosciences announced that toripalimab injection (拓益), an anti-PD-1 monoclonal antibody independently developed by the company, had obtained approval from the National Medical Products Administration (NMPA) for a new indication: the first-line treatment of patients with locally recurrent or metastatic nasopharyngeal carcinoma in combination with cisplatin and gemcitabine. This is the second indication approved for toripalimab in the field of nasopharyngeal carcinoma.
Previous Approvals of Toripalimab
In February 2021, toripalimab (拓益) was approved for the treatment of patients with recurrent/metastatic nasopharyngeal carcinoma (NPC) who failed at least second-line and above systemic therapies, becoming the world’s first anti-PD-1 monoclonal antibody approved for nasopharyngeal carcinoma treatment. With this new breakthrough in first-line treatment for nasopharyngeal carcinoma, toripalimab (拓益) will deliver innovative therapeutic options and longer survival benefits to patients at different treatment stages.
About Nasopharyngeal Carcinoma
Nasopharyngeal carcinoma is a malignant tumor originating from the mucosal epithelium of the nasopharynx and is one of the common head and neck tumors. According to statistics, there were more than 130,000 new cases of nasopharyngeal carcinoma worldwide in 2020, nearly half of which were in China. The disease has a high incidence in southern China (such as Guangdong, Guangxi) and Southeast Asia. For recurrent or metastatic nasopharyngeal carcinoma, current treatment options are limited. The standard first-line treatment regimen is platinum-based two-drug combination chemotherapy, but the median progression-free survival after treatment is only about 7 months.
Since 2016, the team led by Professor Xu Ruihua from Sun Yat-sen University Cancer Center has collaborated with Junshi Biosciences, a local innovative pharmaceutical enterprise, to explore an innovative clinical regimen combining emerging immunotherapy with traditional chemotherapy, and built a clinical layout of "full-line coverage" from later-line to first-line treatment. From the small-sample exploratory Phase Ib/II study, the POLARIS-02 study (a Phase II trial of single-agent immunotherapy for second-line and later-line treatment), to the JUPITER-02 study—the world’s first and largest international multi-center trial of "immunotherapy + chemotherapy" for first-line treatment, toripalimab (拓益) has accumulated solid evidence-based medical evidence in the field of nasopharyngeal carcinoma treatment.
Basis for the Approval of the New Indication
The approval of this new indication is based on the JUPITER-02 study (NCT03581786), a randomized, double-blind, placebo-controlled, international multi-center Phase III clinical trial with Professor Xu Ruihua as the principal investigator, registered simultaneously in China and the United States. From November 2018 to October 2019, the JUPITER-02 study enrolled a total of 289 patients with recurrent/metastatic nasopharyngeal carcinoma who had not received prior chemotherapy at 35 research centers in Chinese mainland, Taiwan China and Singapore.
