Tislelizumab (5) – Tevimbra®
Squamous cell carcinoma of the oesophagus, PD-L1 expression TAP score ≥ 5%, first-line, combination with platinum-based chemotherapy
Characteristics
| Start date | 01.01.2025 – Marketing authorisation: 25.11.2024 |
|---|---|
| Resolution | 18.06.2025 |
| INN | Tislelizumab |
| Brand name | Tevimbra® |
| Pharm. company |
Dossier: BeiGene Germany GmbH
New distributor: BeOne Medicines Germany GmbH |
| G-BA Procedure ID | D-1148 |
| ATC code | L01FF09 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 Squamous cell carcinoma |
| Reason for procedure | New therapeutic indication |
| Specialty | Bundling |
| Therapeutic indication of the resolution |
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Tevimbra in combination with platinum-based chemotherapy is used for the first-line treatment of unresectable, locally advanced or metastatic OSCC in adult patients whose tumours have PD-L1 expression with a TAP score of ≥ 5%. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Adults with non-resectable, locally advanced or metastatic, non-curatively treatable squamous cell carcinoma of the oesophagus whose tumours have PD-L1 expression with a TAP score of ≥ 5 % and also tumour cell PD-L1 expression ≥ 1 % or a combined positive score (CPS) ≥ 10; first-line therapy | - Nivolumab in combination with fluoropyrimidine- and platinum-based combination chemotherapy (only for patients with tumour cell PD-L1 expression ≥ 1%) or – Nivolumab in combination with ipilimumab (only for patients with tumour cell PD-L1 expression ≥ 1%) or – Pembrolizumab in combination with platinum- and fluoropyrimidine-based chemotherapy (only for patients with a combined positive score (CPS) ≥ 10) |
| b) | Adults with unresectable, locally advanced or metastatic, non-curatively treatable squamous cell carcinoma of the oesophagus whose tumours have PD-L1 expression with a TAP score of ≥ 5 % and also no tumour cell PD-L1 expression ≥ 1 % and no combined positive score (CPS) ≥ 10; first-line therapy | Cisplatin in combination with 5-fluorouracil |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (RATIONALE 306) 0 (Data not accepted) |
|---|---|
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Study design
(best subpopulation) |
Data not accepted (Dossier: H2H vs. ACT) |
| Reason for dividing into subpopulations (G-BA) | Disease stage |
- Clinical trials
- The RATIONALE 306 trial is a double-blind Phase III trial comparing tislelizumab in combination with platinum-based chemotherapy against placebo in combination with platinum-based chemotherapy (hereinafter: chemotherapy).
a) Adults with unresectable, locally advanced or metastatic squamous cell carcinoma of the oesophagus that is not amenable to curative treatment, whose tumours exhibit PD-L1 expression with a TAP score of ≥ 5 per cent and, in addition, tumour cellPD-L1 expression of ≥ 1 % or a Combined Positive Score (CPS) of ≥ 10; first-line treatment
- The additional benefit is not proven.
- No data were available for the benefit assessment in comparison with the appropriate comparator therapy.
b) Adults with unresectable, locally advanced or metastatic squamous cell carcinoma of the oesophagus that is not amenable to curative treatment, whose tumours exhibit PD-L1 expression with a TAP score of ≥ 5 % and, in addition, no tumour cellPD-L1 expression of ≥ 1% and no Combined Positive Score (CPS) of ≥ 10; first-line treatment
- An additional benefit is not proven.
- There are therefore no suitable data available to assess the additional benefit of tislelizumab in combination with platinum-based chemotherapy compared with the appropriate comparator therapy.
- In particular, due to the failure to take into account the tumour cell PD-L1 expression characteristic, the patient population from the RATIONALE 306 study submitted by the pharmaceutical manufacturer cannot be used for the benefit assessment.
Courtesy translation only, please refer to the German original.
Associated procedures
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