Amivantamab (3) – Rybrevant®
Non-small cell lung cancer, EGFR exon 19 deletions or exon 21 substitution mutations (L858R), pretreated, combination with carboplatin and pemetrexed
Characteristics
| Start date | 01.02.2025 – Marketing authorisation: 22.08.2024 |
|---|---|
| Resolution | 17.07.2025 |
| INN | Amivantamab |
| Brand name | Rybrevant® |
| Pharm. company | Janssen-Cilag GmbH |
| G-BA Procedure ID | D-1160 |
| ATC code | L01FX18 Other monoclonal antibodies and antibody drug conjugates (L01FX) |
| 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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Rybrevant is indicated in combination with carboplatin and pemetrexed for the treatment of adult patients with advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations after failure of prior therapy including an EGFR tyrosine kinase inhibitor (TKI). |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Adults with advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations after failure of prior therapy, including an EGFR tyrosine kinase inhibitor (TKI); ECOG-PS 0-1 | Atezolizumab in combination with bevacizumab, carboplatin and paclitaxel |
| b) | Adults with advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations after failure of prior therapy including an EGFR tyrosine kinase inhibitor (TKI); ECOG-PS 2 | Carboplatin in combination with a third-generation cytostatic (vinorelbine or gemcitabine or docetaxel or paclitaxel or pemetrexed) see Annex VI to Section K of the medicines directive (AM-RL) or – Carboplatin in combination with nab-paclitaxel or – monotherapy with gemcitabine or vinorelbine (only for patients who are not suitable for platinum-based chemotherapy) |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (MARIPOSA-2) 0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: H2H vs. non-ACT + no ITC) |
| Reason for dividing into subpopulations (G-BA) | Disease stage |
| ACT change | 13.08.2024 – Nach positiven Opinion (Zulassung) |
- Clinical trials
- This is an ongoing, open-label, randomised, multicentre Phase III trial in which amivantamab in combination with lazertinib, carboplatin and pemetrexed (Arm A), and amivantamab in combination with carboplatin and pemetrexed (Arm C), are being compared with chemotherapy comprising carboplatin and pemetrexed (Arm B).
a) Adults with advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations following failure of prior therapy, including an EGFR tyrosine kinase inhibitor (TKI); ECOG PS 0–1
- The additional benefit is not proven.
- For the benefit assessment, the pharmaceutical manufacturer did not provide any directly comparative studies in the dossier of amivantamab in combination with carboplatin and pemetrexed against the appropriate comparator therapy. Furthermore, no indirect comparison was provided.
- Overall, therefore, there are no suitable data available to enable an assessment of the additional benefit of amivantamab in combination with carboplatin and pemetrexed.
- Overall assessment
- The G-BA designated atezolizumab in combination with bevacizumab, carboplatin and paclitaxel as the appropriate comparator therapy. In the comparator arm of the MARIPOSA-2 study, patients were treated with chemotherapy comprising carboplatin and pemetrexed. This does not correspond to the appropriate comparator therapy for patient group a (ECOG PS 0–1). Consequently, there are no suitable data available for an assessment of the additional benefit of amivantamab.
b) Adults with advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations following failure of prior therapy, including an EGFR tyrosine kinase inhibitor (TKI); ECOG PS 2
- The additional benefit is not proven.
- For the benefit assessment, the pharmaceutical manufacturer did not provide any direct comparative studies in the dossier of amivantamab in combination with carboplatin and pemetrexed against the appropriate comparator therapy. Furthermore, no indirect comparison was provided.
- Overall, therefore, there are no suitable data available to enable an assessment of the additional benefit of amivantamab in combination with carboplatin and pemetrexed.
- Overall assessment
- The G-BA identified various chemotherapy regimens (and combinations thereof) as the appropriate comparator therapy. Although the chemotherapy regimen comprising carboplatin and pemetrexed in the comparator arm of the MARIPOSA-2 study corresponds to the appropriate comparator therapy for patient group b (ECOG-PS 2), only patients with ECOG-PS 0–1 were included in the study. Consequently, there are no suitable data available for assessing the additional benefit of amivantamab.
Courtesy translation only, please refer to the German original.
Associated procedures
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