The supplemental NDA is based on the JUPITER-02 study, which is a randomized, double-blind, placebo-controlled phase III study led by Professor Ruihua Xu from Sun Yat-sen University Cancer Center. The results of the study showed that Toripalimab combined with gemcitabine/cisplatin as a first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma significantly prolonged the progression-free survival as compared with the standard first-line treatment of gemcitabine/cisplatin. This study is the world’s largest international phase III clinical study for any checkpoint inhibitor combined with chemotherapy in the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma.
Junshi Biosciences has developed clinical programs using Toripalimab alone or in combination with other therapies for the treatment of nasopharyngeal carcinoma regardless of extent of prior treatments. The company has submitted two sNDAs of toripalimab for the treatment of NPC in China. Toripalimab also obtained Breakthrough Therapy and Orphan Drug Designations from the US FDA for this indication, and its Biologics License Applications (BLA) in the United States will be submitted in the near future. Toripalimab is likely to become the first Chinese anti-PD-1 monoclonal antibody to achieve commercialization in the overseas markets.
Nasopharyngeal carcinoma is a malignant tumor that occurs in nasopharyngeal mucosal epithelium, which is one of the most common head and neck cancers.
Toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing in China. More than thirty company-sponsored clinical studies covering more than fifteen indications have been conducted globally, including in China and the United States. On 17 December 2018, Toripalimab obtained a conditional approval from the NMPA for the second-line treatment of unresectable or metastatic melanoma. Toripalimab was included in the 2019 and 2020 Guidelines of Chinese Society of Clinical Oncology (CSCO) for the Diagnosis and Treatment of Melanoma.