Tislelizumab (2) – Tevimbra®
Non-small cell lung cancer, non-squamous, PD-L1 expression ≥ 50%, first-line, combination with pemetrexed and platinum-containing chemotherapy
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-1126 |
| 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 ACT change |
| Therapeutic indication of the resolution |
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Tevimbra in combination with pemetrexed and platinum-containing chemotherapy is used for the first-line treatment of non-squamous NSCLC with PD-L1 expression on ≥ 50% of tumour cells without EGFR- or ALK-positive mutations in adult patients who: – have locally advanced NSCLC and are not eligible for surgical resection or platinum-based radiochemotherapy, or – have metastatic NSCLC. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adults with locally advanced non-squamous non-small cell lung cancer (NSCLC) who are not eligible for surgical resection or platinum-based radiochemotherapy, or with metastatic non-squamous NSCLC, with PD-L1 expression ≥ 50%, without EGFR or ALK aberrations; 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 pemetrexed and platinum-based chemotherapy (only for patients with ECOG PS 0-1) or – Atezolizumab in combination with bevacizumab, paclitaxel and carboplatin (only for patients with ECOG PS 0-1) or – Atezolizumab in combination with nab-paclitaxel and carboplatin (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) |
Studies and Results
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No. of studies
(best subpopulation) |
1 (RATIONALE 304) 0 (Data not accepted) |
|---|---|
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Study design
(best subpopulation) |
Data not accepted (Dossier: no data submitted) |
| ACT change | 26.03.2024 – Änderung des Therapiestandards |
- Clinical trials
- In the dossier for the benefit assessment, the pharmaceutical manufacturer submitted the results of the RATIONALE 304 registration trial on tislelizumab. This was an open-label, randomised Phase IIIstudy comparing tislelizumab in combination with pemetrexed and platinum-based chemotherapy (cisplatin or carboplatin) against pemetrexed in combination with platinum-based chemotherapy (cisplatin or carboplatin).
Adults with locally advanced non-squamous non-small cell lung cancer (NSCLC), NSCLC) who are not eligible for surgical resection or platinum-based chemoradiotherapy, or with metastatic non-squamous NSCLC, with PD-L1 expression ≥ 50 %, and without EGFR or ALK aberrations; First-line treatment
- An additional benefit is not proven.
- Consequently, there are no suitable data available to assess the additional benefit of tislelizumab in combination with pemetrexed and platinum-based chemotherapy (cisplatin or carboplatin).
- Consequently, it is concluded that for tislelizumab in combination with pemetrexed and platinum-based chemotherapy (cisplatin or carboplatin) for the first-line treatment of locally advanced non--squamous cell NSCLC that is not eligible for surgical resection or platinum-based chemoradiotherapy, or for metastatic non-squamous cell NSCLC with PD-L1 expression ≥ 50 %, without EGFR or ALK aberrations. The additional benefit is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
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