Sotorasib (1) – Lumykras®
Non-small cell lung cancer (NSCLC), KRAS G12C mutation, ≥ 1 therapies
Characteristics
| Start date | 15.02.2022 – Marketing authorisation: 06.01.2022 |
|---|---|
| Resolution | 04.08.2022 repealed subpopulations |
| Limitation date | 01.02.2023 |
| INN | Sotorasib |
| Brand name | Lumykras® |
| Pharm. company | Amgen Europe B.V. |
| G-BA Procedure ID | D-787 |
| ATC code | L01XX73 Other antineoplastic agents (L01XX) |
| 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 | 0.96 g O |
| Therapeutic area | Oncological diseases Non-small-cell lung carcinoma (NSCLC) |
| Reason for procedure |
Initial assessment
Repealed by: Sotorasib (2) (03.08.2023) |
| Regulatory status | Conditional Approval |
| Therapeutic indication of the resolution |
|---|
|
Lumykras is used as monotherapy for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with a KRAS G12C mutation who have experienced progression after at least one prior systemic therapy. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Adults with advanced non-small cell lung cancer (NSCLC) with KRAS p.G12C 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 the case 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)) 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 KRAS p.G12C mutation after first-line therapy with cytotoxic 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 (PD-L1 expression tumours (PD-L1 expression ≥ 1 % of tumour cells)) or - Atezolizumab or - Docetaxel in combination with nintedanib (only for patients with PD-L1 negative tumours and adenocarcinoma histology) |
| c) | Adults with advanced non-small cell lung cancer (NSCLC) with KRAS p.G12C 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. | Patient-specific therapy taking into account previous therapy and histology with choice of afatinib, pemetrexed, erlotinib, docetaxel, docetaxel in combination with ramucirumab, docetaxel in combination with nintedanib and vinorelbine |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (CodeBreak 100) |
|---|---|
|
Study design
(best subpopulation) |
Single-arm + historical comparison |
|
Meta analysis
(best subpopulation) |
no |
| Reason for dividing into subpopulations (G-BA) | Number of medications, Previous treatment |
- Clinical trials
- To assess the additional benefit of sotorasib, the pharmaceutical manufacturer has submitted results from the ongoing, open-label, uncontrolled, multicentre Phase I and II study CodeBreak 100.
- For the present benefit assessment, Phase II of the CodeBreak 100 trial is being considered. This phase included patients with NSCLC and a KRAS p.G12C mutation who had experienced disease progression following treatment with a PD-1/PD-L1 antibody and/or platinum-based combination chemotherapy, as well as targeted therapy for oncogenic driver mutations.
a) Adults with advanced non-small cell lung cancer (NSCLC) with a KRAS p.G12C mutation following first-line treatment with a PD-1/PD-L1 antibody as monotherapy
- An additional benefit is not proven.
- Overall assessment
- The analyses submitted by the pharmaceutical manufacturer consist of a descriptive comparison of individual arms from various studies without adjustment for potentially relevant effect modifiers or prognostic factors.
- Overall, the data submitted are not suitable for assessing additional benefit; consequently, additional benefit of sotorasib over the appropriate comparator therapy is not proven.
b) Adults with advanced non-small cell lung cancer (NSCLC) with a KRAS p.G12C mutation following first-line treatment with cytotoxic chemotherapy
- The additional benefit is not proven.
- Overall assessment
- The analyses submitted by the pharmaceutical manufacturer consist of a descriptive comparison of individual arms from various studies without adjustment for potentially relevant effect modifiers or prognostic factors.
- Overall, the data submitted are not suitable for assessing additional benefit; consequently, additional benefit of sotorasib over the appropriate comparator therapy is not proven.
c) Adults with advanced non-small cell lung cancer (NSCLC) harbouring a KRAS p.G12C 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.
- Overall assessment
- The analyses submitted by the pharmaceutical manufacturer consist of a descriptive comparison of individual arms from various studies without adjustment for potentially relevant effect modifiers or prognostic factors.
- Overall, the data submitted are not suitable for assessing additional benefit; consequently, additional benefit of sotorasib over the appropriate comparator therapy is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Sotorasib (2) | Lumykras® | Amgen Europe B.V. | Non-small cell lung cancer (NSCLC), KRAS G12C mutation, ≥ 1 prior therapy | 480–1,040 | 44% Hint for non-quantifiable additional benefit | |
| Sotorasib (1) | Lumykras® | Amgen Europe B.V. | Non-small cell lung cancer (NSCLC), KRAS G12C mutation, ≥ 1 therapies |
500–1,080
560–1,210 |
100% additional benefit not proven repealed subpopulations |
<< List of all resolutions