Toripalimab (2) – Loqtorzi®

• Clinical trials
  • JUPITER-06 is a randomised, double-blind, two-arm, placebo-controlled, multicentre Phase III trial in which toripalimab in combination with cisplatin and paclitaxel was compared with placebo in combination with cisplatin and paclitaxel.

a) Adults with inoperable advanced, recurrent or metastatic squamous cell carcinoma of the oesophagus with tumour cell PD-L1 expression ≥ 1 % or a Combined Positive Score (CPS) ≥ 10; first-line treatment

• The additional benefit is not proven.
• Overall assessment
  • The data from the JUPITER-06 study are not suitable for assessing the additional benefit of toripalimab in combination with cisplatin and paclitaxel. The comparator therapy in the study was the combination of cisplatin and paclitaxel. This does not correspond to the specified appropriate comparator therapy, neither for patient population a) nor for patient population b). Consequently, the appropriate comparator therapy has not been applied for either patient population, and there are therefore no suitable data available for an assessment of additional benefit.

b) Adults with inoperable advanced, recurrent or metastatic squamous cell carcinoma of the oesophagus who do not have tumour cell PD-L1 expression ≥ 1 % and a Combined Positive Score (CPS) ≥ 10; First-line treatment

• The additional benefit is not proven.
• Overall assessment
  • The data from the JUPITER-06 study are not suitable for assessing the additional benefit of toripalimab in combination with cisplatin and paclitaxel. The comparator therapy in the study was the combination of cisplatin and paclitaxel. This does not correspond to the specified appropriate comparator therapy, neither for patient population a) nor for patient population b). Consequently, the appropriate comparator therapy has not been applied for either patient population, and there are therefore no suitable data available for an assessment of additional benefit.

Courtesy translation only, please refer to the German original.