erus BioSciences(US:CHRS)2021-10-01 18:28Study Overview - JUPITER-06 is a randomized, double-blind, Phase 3 study evaluating Toripalimab plus chemotherapy versus placebo plus chemotherapy for treatment-naive advanced or metastatic Esophageal Squamous Cell Carcinoma (ESCC) [1] - The study included 257 patients in each arm (Toripalimab + Chemotherapy vs Placebo + Chemotherapy) [14] Efficacy Results - The addition of Toripalimab to paclitaxel + cisplatin (TP) chemotherapy showed superior Progression-Free Survival (PFS) compared to TP chemotherapy alone, with a median PFS of 5.7 months versus 5.5 months (HR=0.58, P<0.00001) [25, 16] - The addition of Toripalimab to paclitaxel + cisplatin (TP) chemotherapy showed superior Overall Survival (OS) compared to TP chemotherapy alone, with a median OS of 17.0 months versus 11.0 months (HR=0.58, P=0.00036) [25, 20] - The 1-year Progression-Free Survival Rate was 27.8% in the Toripalimab + Chemo arm versus 6.1% in the Placebo + Chemo arm [16] - The 1-year Overall Survival Rate was 66.0% in the Toripalimab + Chemo arm versus 43.7% in the Placebo + Chemo arm [20] - The 2-year Overall Survival Rate was Not estimable in the Toripalimab + Chemo arm versus 17.5% in the Placebo + Chemo arm [20] Safety - Any Treatment-Related Adverse Events (TRAEs) occurred in 97.3% of patients in both the Toripalimab + Chemotherapy and Placebo + Chemotherapy arms [22] - Grade ≥3 TRAEs occurred in 64.6% of patients in the Toripalimab + Chemotherapy arm versus 56.0% in the Placebo + Chemotherapy arm [22] - Immune-related Adverse Events occurred in 37.0% of patients in the Toripalimab + Chemotherapy arm versus 26.5% in the Placebo + Chemotherapy arm [22]