Esophagealcancer is one of the most common malignant tumors, with more than 600,000 newlydiagnosed cases and more than 540,000 deaths reported in 2020 worldwide. Mostpatients with newly diagnosed esophageal squamous cell carcinoma (ESCC) presentwith advanced disease due to the indistinctive clinical symptoms of early-stageESCC. Currently, platinum-based chemotherapy, such as paclitaxel plus cisplatin(TP), is the standard first-line treatment for advanced ESCC. However, patientswith these regimens have limited benefit, and new drugs are urgently needed.

Recently, a multi-center Phase IIIclinical trial (JUPITER-06 study) of Toripalimab plus chemotherapy intreatment-naive, advanced esophageal squamous cell carcinoma (JUPITER-06) conductedby Professor Ruihua Xu and Professor Feng Wang from Sun Yat-Sen UniversityCancer Center was published in Cancer Cell. Toripalimab, a humanizedIgG4K monoclonal antibody, is the first domestic anti-PD-1 drug in China. Inthis randomized, double-blind, placebo-controlled phase 3 clinical study, 514treatment-naïve patients with ESCC were randomly assigned 1:1 to the toripalimabplus TP arm (n = 257) or placebo plus TP arm (n = 257). In the chemotherapyphase, patients would receive 6 cycles of treatment: paclitaxel and cisplatinplus toripalimab or placebo. In the maintenance phase, patients would receivetoripalimab or placebo every 3 weeks.

Significant improvement inprogression-free survival (PFS) was found in the toripalimab plus TP group thanin the placebo plus TP group ([HR]=0.58; 95% CI, 0.46-0.74; P<0.0001). One-yearPFS rate raised from 6.1% to 27.8%. Additionally, overall survival (OS) wassignificantly improved in the toripalimab plus TP group compared with theplacebo plus TP group (HR=0.58; 95% CI, 0.43-0.78; P=0.0004). One-year OS rateraised from 43.7% to 66.0%. The objective response rate of toripalimab plus TPgroup was significantly higher than placebo plus TP group (69.3% vs. 52.1%;P<0.0001). What’s more, the incidences of grade≥3 treatment-emergent adverseevents were similar between the two arms( 73.2% [toripalimab plus TP] vs. 70.0%[placebo plus TP]).

In conclusion, Toripalimab plus TPsignificantly improves PFS and OS in patients with treatment- naïve, advancedESCC, with a manageable safety profile.