Tislelizumab (3) – Tevimbra®
Non-small cell lung cancer, squamous cell, first-line, combination with carboplatin and either paclitaxel or nab-paclitaxel
Characteristics
| Start date | 01.01.2025 – Marketing authorisation: 08.07.2024 |
|---|---|
| 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-1127 |
| ATC code | L01FF09 PD-1/PDL-1 inhibitors (L01FF) |
| ICD-10 codes (AIS) | C34.0Malignant neoplasm of carina, C34.1Malignant neoplasm of upper lobe, bronchus or lung, C34.2Malignant neoplasm of middle lobe, bronchus or lung, C34.3Malignant neoplasm of lower lobe, bronchus or lung, C34.8Malignant neoplasm of overlapping sites of bronchus and lung, C34.9Malignant neoplasm of unspecified part of bronchus or lung |
| Alpha-ID codes (AIS) | I111155Carcinoma of the upper lobe bronchus, I116693Non-small cell lung cancer, I24595Carcinoma of the main bronchus, I30015Lung carcinoma of the middle lobe, I30021Lung carcinoma of the lower lobe, I30022Malignant neoplasm of the bronchi and lungs, overlapping several sub-areas |
| Therapeutic area | Oncological diseases Non-small-cell lung carcinoma (NSCLC) |
| Reason for procedure | New therapeutic indication |
| Specialty | Bundling |
| Therapeutic indication of the resolution |
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Tevimbra in combination with carboplatin and either paclitaxel or nab-paclitaxel is used for the first-line treatment of squamous NSCLC in adult patients who: – have locally advanced NSCLC and are not candidates for surgical resection or platinum-based radiochemotherapy; or – have metastatic NSCLC. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Adults with locally advanced squamous non-small cell lung cancer (NSCLC) who are not eligible for surgical resection or platinum-based radiochemotherapy, or with metastatic squamous NSCLC, with PD-L1 expression ≥ 50%; first-line therapy | - Pembrolizumab as monotherapy or – Atezolizumab as monotherapy or – Cemiplimab as monotherapy or – Nivolumab in combination with ipilimumab and 2 cycles of platinum-based chemotherapy (only for patients with ECOG PS 0-1) or – Pembrolizumab in combination with carboplatin and either paclitaxel or nab-paclitaxel (only for patients with ECOG PS 0-1) or – Cemiplimab in combination with platinum-based chemotherapy (only for patients with ECOG PS 0-1) or – Durvalumab in combination with tremelimumab and platinum-based chemotherapy (only for patients with ECOG PS 0-1) |
| b) | Adults with locally advanced squamous non-small cell lung cancer (NSCLC) who are not eligible for surgical resection or platinum-based radiochemotherapy, or with metastatic squamous NSCLC, with PD-L1 expression < 50%; first-line therapy | - Pembrolizumab in combination with carboplatin and either paclitaxel or nab-paclitaxel (only for patients with ECOG PS 0-1) or – Atezolizumab as monotherapy (only for patients with PD-L1 expression ≥ 10% in tumour-infiltrating immune cells) or – Nivolumab in combination with ipilimumab and 2 cycles of platinum-based chemotherapy (only for patients with ECOG PS 0-1) or – Cemiplimab in combination with platinum-based chemotherapy (only for patients with ECOG PS 0-1) or – Durvalumab in combination with tremelimumab and platinum-based chemotherapy (only for patients with ECOG PS 0-1) or – Carboplatin in combination with a third-generation cytostatic agent (vinorelbine or gemcitabine or docetaxel or paclitaxel) see Annex VI to Section K of the medicines directive (AM-RL) (only for patients with ECOG PS 2) or – Carboplatin in combination with nab-paclitaxel (only for patients with ECOG PS 2) |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (Data not accepted) |
|---|---|
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Study design
(best subpopulation) |
Data not accepted (Dossier: no data submitted) |
| Reason for dividing into subpopulations (G-BA) | Disease stage |
- Clinical trials
- In the dossier for the benefit assessment, the pharmaceutical manufacturer submitted the results of the RATIONALE 307 registration trial on tislelizumab. This was an open-label, randomised Phase III trial comparing tislelizumab in combination with carboplatin and either paclitaxel (arm A) or nab-paclitaxel (arm B) with carboplatin in combination with paclitaxel (arm C).
a) Adults with locally advanced squamous cell non-small cell lung cancer (NSCLC), NSCLC) who are not eligible for surgical resection or platinum-based chemoradiotherapy, or with metastatic squamous NSCLC, with PD-L1 expression ≥ 50%; first-line treatment
- The conclusion is that, for tislelizumab in combination with carboplatin and either paclitaxel or nab-paclitaxel for the first-line treatment of locally advanced squamous cell NSCLC that is not eligible for surgical resection or platinum-based chemoradiotherapy, or for metastatic squamous NSCLC, an additional benefit is not proven.
b) Adults with locally advanced squamous cell non-small cell lung cancer (NSCLC, NSCLC) who are not eligible for surgical resection or platinum-based chemoradiotherapy, or with metastatic squamous NSCLC, with PD-L1 expression < 50%; first-line treatment
- In conclusion, it is established that for tislelizumab in combination with carboplatin and either paclitaxel or nab-paclitaxel for the first-line treatment of locally advanced squamous cell NSCLC, which is not eligible for surgical resection or platinum-based chemoradiotherapy, or for metastatic squamous cell NSCLC, an additional benefit is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
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