Junshi Biosciences Announces Approval of Supplemental New Drug Application by NMPA for Toripalimab in Combination With Cisplatin and Gemcitabine as First-Line Treatment for Patients With Locally Recurrent or Metastatic Nasopharyngeal Carcinoma

The sNDA is based on the JUPITER-02 study (NCT03581786), which is a randomized, double-blind, placebo-controlled and international multi-center Phase III clinical study led by Professor Ruihua Xu from Sun Yat-sen University Cancer Center. The results of the study showed that when compared with the standard first-line treatment of gemcitabine/cisplatin, toripalimab in combination with gemcitabine and cisplatin as the first-line treatment for patients with recurrent or metastatic NPC has better progression-free survival, higher objective response rate, longer duration of response and survival benefits regardless of PD-L1 expression status with a manageable safety profile. This study is the world’s largest Phase III clinical study for a checkpoint inhibitor in combination with chemotherapy for the first-line treatment of recurrent or metastatic NPC. The study results of JUPITER-02 were presented in the form of a Late-breaking Abstract (LBA) at the plenary session at the annual meeting of the American Society of Clinical Oncology (ASCO 2021) and were published as the cover article of the September 2021 issue of Nature Medicine. Read More