Tepotinib (1) – Tepmetko®
Non-small cell lung cancer (NSCLC), METex14 skipping, pre-treated patients
Characteristics
| Start date | 01.03.2022 – Marketing authorisation: 16.02.2022 |
|---|---|
| Resolution | 01.09.2022 |
| INN | Tepotinib |
| Brand name | Tepmetko® |
| Pharm. company | Merck Europe B.V. |
| G-BA Procedure ID | D-781 |
| ATC code | L01EP02 PROTEIN KINASE INHIBITORS (L01E) |
| 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 |
| DDD | 0.45 g O |
| Therapeutic area | Oncological diseases Non-small-cell lung carcinoma (NSCLC) |
| Reason for procedure | Initial assessment |
| Therapeutic indication of the resolution |
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Tepmetko is used in adult patients with advanced non-small cell lung cancer (NSCLC) with alterations leading to METex14 skipping (exon14 skipping in the mesenchymal-epithelial transition factor gene) who require systemic therapy after platinum-based chemotherapy and/or treatment with immunotherapy. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Adults with advanced non-small cell lung cancer (NSCLC) with MET tyrosine kinase receptor exon 14 (METex14) skipping alterations after first-line therapy with a PD-1/PD-L1 antibody as monotherapy. | Cisplatin in combination with a third-generation cytostatic drug (vinorelbine or gemcitabine or docetaxel or paclitaxel or pemetrexed (except in the case of predominantly plate epithelial histology)) or - carboplatin in combination with a third-generation cytostatic (vinorelbine or gemcitabine or docetaxel or paclitaxel or pemetrexed (except for predominantly squamous histology). plate epithelial histology)) or - Carboplatin in combination with nab-paclitaxel or - Monotherapy with gemcitabine or vinorelbine (only for patients with ECOG performance status 2 as an alternative to platinum-based combination treatment) |
| b) | Adults with advanced non-small cell lung cancer (NSCLC) with MET tyrosine kinase receptor exon 14 (METex14) skipping changes after first-line platinum-containing chemotherapy. | Docetaxel (only for patients with PD-L1 negative tumours) or - Pemetrexed (only for patients with PD-L1 negative tumours and except in the case of predominantly squamous histology) or - Nivolumab or - Pembrolizumab (only for patients with PD-L1 expressing tumours, tumour proportion tumours, tumour proportion score (TPS) ≥ 1 %) or - atezolizumab or - docetaxel in combination with nintedanib (only for patients with PDL1 negative tumours and adenocarcinoma histology) |
| c) | Adults with advanced non-small cell lung cancer (NSCLC) with MET tyrosine kinase receptor exon 14 (METex14) skipping changes after first-line therapy with a PD-1/PD-L1 antibody in combination with platinum-containing chemotherapy or after sequential therapy with a PD-1/PDL1 antibody and platinum-containing chemotherapy. | Patient-specific therapy taking into account prior therapy and histology with choice of afatinib, pemetrexed, erlotinib, docetaxel, docetaxel in combination with ramucirumab, and docetaxel in combination with nintedanib and vinorelbine. |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (VISION) |
|---|---|
|
Study design
(best subpopulation) |
Single-arm + no comparison |
|
Meta analysis
(best subpopulation) |
no |
| Reason for dividing into subpopulations (G-BA) | Number of medications, Previous treatment |
- Clinical trials
- To demonstrate the additional benefit of tepotinib for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with a METex14 skipping mutation who require systemic therapy following platinum-based chemotherapy and/or immunotherapy, the pharmaceutical manufacturer presents results from the ongoing open-label, two-part, uncontrolled, multicentre Phase II VISION trial.
- These two studies are retrospective, non-interventional studies conducted by the pharmaceutical manufacturer, based on electronic health records from oncology practices in the USA (Study 0015) and patient records from several oncology centres (Study 0035).
a) Adults with advanced non-small cell lung cancer (NSCLC) with MET tyrosine kinase receptor exon 14 (METex14)skipping alterations following first-line treatment with a PD-1/PD-L1 antibody as monotherapy
- An additional benefit is not proven.
b) Adults with advanced non-small cell lung cancer (NSCLC) with MET tyrosine kinase receptor exon 14 (METex14-) skipping mutations following first-line treatment with platinum-based chemotherapy
- The additional benefit is not proven.
c) Adults with advanced non-small cell lung cancer (NSCLC) with MET tyrosine kinase receptor exon 14 (METex14)skipping alterations following first-line treatment with a PD-1/PD-L1 antibody in combination with platinum-based chemotherapy or following sequential treatment with a PD-1/PD-L1 antibody and platinum-based chemotherapy
- The additional benefit is not proven.
- Overall assessment
- The analyses submitted by the pharmaceutical manufacturer consist of a purely descriptive comparison of individual endpoints from various studies.
- The results of the single-arm VISION study submitted on their own are not suitable for assessing the additional benefit of tepotinib, as they do not allow for a comparison with the appropriate comparator therapy.
- Overall, the data submitted are not suitable for assessing additional benefit; consequently, additional benefit of tepotinib over the appropriate comparator therapy is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Tepotinib (1) | Tepmetko® | Merck Europe B.V. | Non-small cell lung cancer (NSCLC), METex14 skipping, pre-treated patients | 540–910 | 100% additional benefit not proven |
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