Toripalimab (2) – Loqtorzi®
Squamous cell carcinoma of the oesophagus, first-line treatment, in combination with cisplatin and paclitaxel
Characteristics
| Start date | 15.01.2026 – Marketing authorisation: 19.09.2024 |
|---|---|
| Resolution | 02.07.2026 |
| INN | Toripalimab |
| Brand name | Loqtorzi® |
| Pharm. company | LEO Pharma GmbH |
| G-BA Procedure ID | D-1273 |
| ATC code | L01FF13 PD-1/PDL-1 inhibitors (L01FF) |
| ICD-10 codes (AIS) | C15.0, C15.1, C15.2, C15.3Malignant neoplasm of upper third of esophagus, C15.4Malignant neoplasm of middle third of esophagus, C15.5Malignant neoplasm of lower third of esophagus, C15.8Malignant neoplasm of overlapping sites of esophagus, C15.9Malignant neoplasm of esophagus, unspecified |
| Alpha-ID codes (AIS) | I113992Squamous cell carcinoma of the esophagus, I134243Oesophageal carcinoma, overlapping several sub-areas, I25397Malignant neoplasm of the cervical esophagus, I25398Malignant neoplasm of the thoracic esophagus, I25399Malignant neoplasm of the abdominal esophagus, I29934Malignant neoplasm of the upper third of the esophagus, I29935Malignant neoplasm of the middle third of the esophagus, I29936Malignant neoplasm of the lower third of the esophagus |
| Therapeutic area | Oncological diseases |
| Reason for procedure | Initial assessment |
| Therapeutic indication of the resolution |
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Loqtorzi is indicated for use in combination with cisplatin and paclitaxel for the first-line treatment of adult patients with inoperable advanced, recurrent or metastatic squamous cell carcinoma of the oesophagus. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Erwachsene mit einem inoperablen fortgeschrittenen, rezidivierenden oder metastasierten Plattenepithelkarzinom des Ösophagus mit einer Tumorzell-PD-L1 Expression ≥ 1 % oder einem Combined Positive Score (CPS) ≥ 10; Erstlinientherapie | |
| b) | Erwachsene mit einem inoperablen fortgeschrittenen, rezidivierenden oder metastasierten Plattenepithelkarzinom des Ösophagus, die keine Tumorzell-PD-L1 Expression ≥ 1 % und keinen Combined Positive Score (CPS) ≥ 10 aufweisen; Erstlinientherapie |
Studies and Results
- 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.
Associated procedures
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