Tislelizumab (6) – Tevimbra®
Adenocarcinoma of the stomach or gastro-oesophageal junction, PD-L1 expression ≥ 5, HER2-, first-line, combination with platinum- and fluoropyrimidine-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-1149 |
| ATC code | L01FF09 PD-1/PDL-1 inhibitors (L01FF) |
| ICD-10 codes (AIS) | C16.0Malignant neoplasm of cardiac orifice, C16.1Malignant neoplasm of fundus of stomach, C16.2Malignant neoplasm of body of stomach, C16.4Malignant neoplasm of prepylorus, C16.5Malignant neoplasm of lesser curvature of stomach, not classifiable to C16.1-C16.4, C16.6Malignant neoplasm of greater curvature of stomach, not classifiable to C16.0-C16.4, C16.8Malignant neoplasm of overlapping sites of stomach, C16.9Gastric cancer NOS |
| Alpha-ID codes (AIS) | I103100Malignant neoplasm of the gastroesophageal junction, I107038Malignant neoplasm of the anterior stomach wall n.c, I112789Adenocarcinoma of the stomach, I25400Malignant neoplasm of the pylorus, I29937Malignant neoplasm of the ventricular fundus, I29941Malignant neoplasm of the corpus ventriculi, I29947Malignant neoplasm of the small curvature of the stomach, I29950Malignant neoplasm of the large gastric curvature |
| Therapeutic area | Oncological diseases Adenocarcinoma (AC) |
| Reason for procedure | New therapeutic indication |
| Specialty | Bundling ACT change |
| Therapeutic indication of the resolution |
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Tevimbra in combination with platinum- and fluoropyrimidine-based chemotherapy is used for the first-line treatment of locally advanced, unresectable or metastatic HER-2-negative adenocarcinoma of the stomach or gastroesophageal junction (G/GEJ) in adult patients whose tumours have PD-L1 expression with a TAP score of ≥ 5%. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adults with locally advanced, unresectable or metastatic HER2-negative adenocarcinoma of the stomach or gastro-oesophageal junction with a tumour PD-L1 expression of ≥ 5% (tumour area positivity; TAP score); first-line therapy | - Nivolumab in combination with fluoropyrimidine- and platinum-based combination chemotherapy (only for tumours with PD-L1 expression (CPS) ≥ 5) or – Pembrolizumab in combination with fluoropyrimidine- and platinum-based combination chemotherapy (only for tumours with PD-L1 expression (CPS) ≥ 1) |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (RATIONALE 305) 0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: H2H vs. ACT) |
| ACT change | 10.12.2024 – Änderung des Therapiestandards |
- Clinical trials
- The completed, double-blind Phase IIIRCT RATIONALE 305, patients with locally advanced, unresectable or metastatic HER-2-negative adenocarcinoma of the stomach or the gastro-oesophageal junction, whose disease had not previously been treated with systemic therapy, were enrolled.
- As first-line treatment, 501 patients received tislelizumab and 496 patients received a placebo – each in combination with platinum- and fluoropyrimidine-based chemotherapy consisting of either oxaliplatin and capecitabine or cisplatin and 5-fluorouracil.
Adults with locally advanced, unresectable or metastatic HER2-negative adenocarcinoma of the stomach or the gastro-oesophageal junction with tumour PD-L1 expression of ≥ 5 % (Tumour Area Positivity; TAP score); first-line treatment
- The additional benefit is not proven.
- As the data submitted do not allow for a comparison with the appropriate comparator therapy, no evaluable data are available.
- Consequently, the G-BA concludes that, for tislelizumab in combination with platinum- and fluoropyrimidine--based chemotherapy for the first-line treatment of locally advanced, unresectable or metastatic HER-2-negative adenocarcinoma of the stomach or the gastro-oesophageal junction (G/GEJ) in adult patients whose tumours exhibit PD-L1 expression with a TAP score (Tumour Area Positivity) of ≥ 5 per cent, an additional benefit is not proven.
- Conclusion
- Consequently, the G-BA concludes that no additional benefit is proven for tislelizumab in combination with platinum- and fluoropyrimidine-based chemotherapy.
Courtesy translation only, please refer to the German original.
Associated procedures
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