Capmatinib (1) – Tabrecta®
Non-small cell lung cancer (NSCLC), METex14 skipping mutation, pre-treated patients
Characteristics
| Start date | 15.08.2022 – Marketing authorisation: 20.06.2022 |
|---|---|
| Resolution | 02.02.2023 |
| INN | Capmatinib |
| Brand name | Tabrecta® |
| Pharm. company | Novartis Pharma GmbH |
| G-BA Procedure ID | D-855 |
| ATC code | L01EP01 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 | 0.8 g O |
| Therapeutic area | Oncological diseases Non-small-cell lung carcinoma (NSCLC) |
| Reason for procedure | Initial assessment |
| Therapeutic indication of the resolution |
|---|
|
Tabrecta as monotherapy is used to treat adult patients with advanced non-small cell lung cancer (NSCLC) with alterations leading to METex14 skipping (exon 14 skipping in the mesenchymal-epithelial transition factor gene) who require systemic therapy following treatment with immunotherapy and/or platinum-based chemotherapy |
| Subpopulation | Indication | Comparator |
|---|---|---|
| 1) | Adults with advanced non-small cell lung carcinoma (NSCLC) with METex14 skipping (exon 14 skipping in the mesenchymal-epithelial transition factor gene) mutation after first-line therapy with a PD-1/PD-L1 antibody as monotherapy. | - Cisplatin in combination with a third-generation cytostatic (vinorelbine or gemcitabine or docetaxel or paclitaxel or pemetrexed (except in cases of predominantly squamous histology)) or - Carboplatin in combination with a third-generation cytostatic (vinorelbine or gemcitabine or docetaxel or paclitaxel or pemetrexed (except in the case of predominantly squamous histology)) cf. Annex VI to Section K of the Medicinal Products Guideline 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) | Erwachsene mit fortgeschrittenem nicht-kleinzelligen Lungenkarzinom (NSCLC) mit METex14-Skipping (Exon-14-Skipping im mesenchymal-epithelialen Transitionsfaktor- Gen)-Mutation nach Erstlinientherapie mit einer platinhaltigen Chemotherapie | - Docetaxel (only for patients with PD-L1 negative tumors) or - Pemetrexed (only for patients with PD-L1 negative tumors and except in cases of predominantly squamous histology) or - nivolumab or - Pembrolizumab (only for patients with PD-L1 expressing tumors, tumor proportion score (TPS) ≥ 1%) or - atezolizumab or - Docetaxel in combination with nintedanib (only for patients with PD- L1 negative tumors and adenocarcinoma histology). |
| c) | Adults with advanced non-small cell lung carcinoma (NSCLC) with METex14 skipping (exon 14 skipping in the mesenchymal-epithelial transition factor gene) mutation 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/PD-L1 antibody and platinum-containing chemotherapy. | Patientenindividuelle Therapie unter Berücksichtigung der Vortherapie und Histologie unter Auswahl von - Afatinib, - Pemetrexed, - Erlotinib, - Docetaxel, - Docetaxel in Kombination mit Ramucirumab, - Docetaxel in Kombination mit Nintedanib und - Vinorelbin. |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (GEOMETRY mono-1) |
|---|---|
|
Study design
(best subpopulation) |
Single-arm + ITC (PID/PSM) |
|
Meta analysis
(best subpopulation) |
no |
| Reason for dividing into subpopulations (G-BA) | Previous treatment |
- Clinical trials
- To demonstrate the additional benefit of capmatinib 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, non--controlled, multicentre Phase II cohort study GEOMETRY mono-1.
- The RECAP study is a comparison of individual arms from different trials, comprising patient-specific data on capmatinib from the prospective GEOMETRY mono-1 cohort study and patient-specific data from the database of the National Network for Genomic Medicine in Lung Cancer (nNGM) to identify the appropriate comparator therapy.
a) Adults with advanced non-small cell lung cancer (NSCLC) harbouring a METex14-skipping (exon 14 skipping in the mesenchymal-epithelial transition factor gene) following first-line treatment with a PD-1/PD-L1 antibody as monotherapy
- An additional benefit is not proven.
- mortality
- There are therefore no data available for assessing the additional benefit of capmatinib compared with the appropriate comparator therapy.
- morbidity
- There are therefore no data available to assess the additional benefit of capmatinib compared with the appropriate comparator therapy.
- Health-related quality of life
- There are therefore no data available to assess the additional benefit of capmatinib compared with the appropriate comparator therapy.
- Side effects
- Due to a lack of suitable registry data, the pharmaceutical manufacturer is unable to assess the information on side effects.
- Overall assessment
- As neither of the two studies is, on the whole, suitable for comparison with the appropriate comparator therapy, an additional benefit of capmatinib over the appropriate comparator therapy is not proven.
b) Adults with advanced non-small cell lung cancer (NSCLC) with METex14 skipping (exon 14 skipping in the mesenchymal-epithelial transition factor gene) following first-line treatment with platinum-based chemotherapy
- The additional benefit is not proven.
- mortality
- There are therefore no data available for assessing the additional benefit of capmatinib compared with the appropriate comparator therapy.
- morbidity
- For the patient population that received cytotoxic chemotherapy as first-line treatment, a statistically significant difference was observed between the treatment arms in the comparison of individual arms from different studies without a bridging comparator, as presented by the pharmaceutical manufacturer.
- However, due to the systematically shortened observation period in the intervention arm, the results for the endpoint of CNS progression are not suitable for a comparison of individual arms.
- Health-related quality of life
- There are therefore no data available for assessing the additional benefit of capmatinib compared with the appropriate comparator therapy.
- Side effects
- Due to a lack of suitable registry data, the pharmaceutical manufacturer considers that the information on side effects cannot be assessed.
- Overall assessment
- As neither of the two studies is, on the whole, suitable for comparison with the appropriate comparator therapy, an additional benefit of capmatinib over the appropriate comparator therapy is not proven.
c) Adults with advanced non-small cell lung cancer (NSCLC) harbouring a METex14-skipping (exon 14 skipping in the mesenchymal-epithelial transition factor gene) mutation following first-line treatment with a PD-1/PD-L1 antibody in combination with platinum-based chemotherapy, or following sequential therapy with a PD-1/PD-L1 antibody and platinum-based chemotherapy
- The additional benefit is not proven.
- mortality
- There are therefore no data available to assess the additional benefit of capmatinib compared with the appropriate comparator therapy.
- morbidity
- There are therefore no data available to assess the additional benefit of capmatinib compared with the appropriate comparator therapy.
- Health-related quality of life
- There are therefore no data available to assess the additional benefit of capmatinib compared with the appropriate comparator therapy.
- Side effects
- Due to a lack of suitable registry data, the pharmaceutical manufacturer is unable to assess the information on side effects.
- Overall assessment
- As neither of the two studies is, on the whole, suitable for comparison with the appropriate comparator therapy, the additional benefit of capmatinib over the appropriate comparator therapy is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Capmatinib (1) | Tabrecta® | Novartis Pharma GmbH | Non-small cell lung cancer (NSCLC), METex14 skipping mutation, pre-treated patients | 540–900 | 100% additional benefit not proven |
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