Tuoyi (toripalimab) approved in China for first-line treatment of esophageal squamous cell carcinoma

On May 13, 2022, the official website of the China Food and Drug Administration showed that Junshi Biologics' toripalimab injection was approved for marketing for a new indication, and it can be used in combination with platinum-containing chemotherapy for the first-line treatment of locally advanced or metastatic esophageal squamous cell carcinoma.

The approval was based on the results of a Phase III clinical trial (JUPITER-06 study) of toripalimab in combination with chemotherapy as first-line treatment of advanced or metastatic esophageal squamous cell carcinoma (ESCC).
The JUPITER-06 study enrolled a total of 514 patients with untreated esophageal squamous cell carcinoma and randomly assigned them to the toripalimab combined with TP chemotherapy group (n=257) or the placebo combined with TP chemotherapy group (n=257). The results showed that compared with placebo combined with chemotherapy, toripalimab combined with chemotherapy: 1) can significantly prolong the patient's PFS and reduce the risk of disease progression or death by 42%; 2) significantly extend the median OS (17.0 months vs 11.0 months), and reduce the patient's risk of death by 42%; 3) increase the ORR by 17.2% (69.3% vs 52.1%). In terms of safety, the incidence of grade ≥3 treatment adverse events (TEAE) in the toripalimab combined with chemotherapy group was 73.2% (vs 70.0%), and the fatal AEs related to the study treatment were 0.4% (vs 1.2%).
The results of this study show that the PD-1 inhibitor toripalimab can significantly improve the PFS and OS of patients with advanced or metastatic esophageal squamous cell carcinoma as first-line treatment. Regardless of PD-L1 expression, this combination regimen is effective, while significantly improving the ORR and disease control rate (DCR), with a manageable safety profile, and providing a new first-line treatment option for the treatment of advanced esophageal squamous cell carcinoma.
Tuoyi (toripalimab injection) is the first domestically produced monoclonal antibody drug targeting PD-1 approved for marketing in China, and has been approved for 5 domestic indications. At the same time, it is also the first domestic anti-PD-1 monoclonal antibody to submit a BLA to the FDA. At present, toripalimab has been granted 2 breakthrough therapy designations, 1 fast track designation, 1 priority review designation and 4 orphan drug designations by the FDA in the fields of mucosal melanoma, nasopharyngeal cancer, soft tissue sarcoma and esophageal cancer.
Esophageal squamous cell carcinoma (ESCC) is the main subtype of esophageal cancer (EC). Patients with esophageal cancer have mild symptoms in the early stages and are often diagnosed at an advanced stage. For patients with advanced or metastatic esophageal squamous cell carcinoma, platinum-containing double-drug chemotherapy regimens are currently used as first-line treatment. However, since different regimens have similar efficacy and limited survival benefit, there is an urgent need for new drugs and treatment regimens in clinical practice.
Reference link: "Release of information on drug approval documents to be received on May 13, 2022" https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20220513124639174.html