Atezolizumab (9) – Tecentriq®
Non-small cell lung carcinoma (NSCLC), PD-L1 expression ≥50 % on TC or ≥10 % on IC, EGFR/ALK negative, first-line
Characteristics
| Start date | 01.06.2021 – Marketing authorisation: 30.04.2021 |
|---|---|
| Resolution | 19.11.2021 |
| INN | Atezolizumab |
| Brand name | Tecentriq® |
| Pharm. company | Roche Pharma AG |
| G-BA Procedure ID | D-671 |
| ATC code | L01FF05 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 |
| DDD | 57 mg P |
| Therapeutic area | Oncological diseases Non-small-cell lung carcinoma (NSCLC) |
| Reason for procedure | New therapeutic indication |
| Therapeutic indication of the resolution |
|---|
|
Tecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have a PD-L1 expression ≥ 50% tumour cells (TC) or ≥ 10% tumour-infiltrating immune cells (IC) and who do not have EGFR mutant or ALK-positive NSCLC |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Adults with metastatic non-small cell lung cancer (NSCLC) whose Tumors have PD-L1 expression ≥ 50% of tumor cells and who do not have EGFR mutations or ALK-positive NSCLC; first-line | Pembrolizumab as monotherapy |
| b) | Adults with metastatic non-small cell lung cancer (NSCLC) whose tumors have PD-L1 expression < 50% of tumor cells and PD-L1 expression ≥ 10% In tumor-infiltrating immune cells, and who do not have EGFR mutations or have ALK-positive NSCLC; first-line. | - Cisplatin in combination with a third-generation cytostatic (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 in cases of predominantly squamous histology)) or - carboplatin in combination with nab-paclitaxel or - Pembrolizumab in combination with pemetrexed and platinum-containing chemotherapy. (only for adults with non-plate epithelial histology) or - Pembrolizumab in combination with carboplatin and either paclitaxel or nabPaclitaxel (for adults with squamous histology only) or - Monotherapy with gemcitabine or vinorelbine (only for adults with ECOG Performance Status 2 as an alternative to platinum-based combination treatment). |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (IMpower110) |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. non-ACT + ITC (Bucher) |
|
Meta analysis
(best subpopulation) |
no |
| Reason for dividing into subpopulations (G-BA) | Disease stage |
a) Adults with metastatic non-small cell lung cancer (NSCLC) whose tumours exhibit PD-L1 expression in ≥ 50 per cent of tumour cells and who do not have EGFR mutations or ALK-positive NSCLC; first-line treatment
- In conclusion, the G-BA finds that for atezolizumab as monotherapy for the treatment of adults with metastatic NSCLC whose tumours have a PD-L1 expression of ≥ 50 per cent of tumour cells and who do not have EGFR mutations or ALK-positive NSCLC, additional benefit is not proven.
- mortality
- For the endpoint of overall survival, the adjusted indirect comparison shows no statistically significant difference between the treatment groups.
- morbidity
- The pharmaceutical manufacturer has not submitted any data on these endpoints for the relevant patient population of the IMPower110 trial for the adjusted indirect comparison.
- Consequently, no usable data are available for an adjusted indirect comparison for the morbidity endpoint category.
- Health-related quality of life
- The pharmaceutical manufacturer has not submitted any data for the relevant patient population of the IMPower110 study for the adjusted indirect comparison regarding this endpoint.
- Consequently, no usable data are available for an adjusted indirect comparison for the health-related quality of life endpoint category.
- Side effects
- For the endpoints serious adverse events (SAEs) and severe adverse events (CTCAE grade ≥ 3), the adjusted indirect comparison shows no statistically significant difference between the treatment arms.
- For the endpoint ‘therapy discontinuation due to AEs’, the adjusted indirect comparison shows a statistically significant difference in favour of atezolizumab.
- However, this effect is subject to excessive uncertainty and is deemed insufficient to infer any additional benefit with regard to side effects.
- The data on immune-mediated AEs are considered unusable.
- Overall assessment / Conclusion
- For the assessment of the additional benefit of atezolizumab for first-line treatment of adults with metastatic non-small cell lung cancer (NSCLC), whose tumours exhibit PD-L1 expression in ≥ 50 per cent of tumour cells or a tumour proportion score [TPS] of ≥ 50 per cent and who do not have EGFR mutations or ALK-positive NSCLC, results are available on overall survival and side effects compared with the appropriate comparator therapy, pembrolizumab.
- For the endpoint of overall survival, there is no statistically significant difference between the treatment arms.
- For the endpoint category of morbidity and health-related quality of life, no usable data are available for an adjusted indirect comparison.
- In the adverse event endpoint category, there is no statistically significant difference between the treatment arms for the endpoints of serious adverse events (SAEs) and severe AEs (CTCAE grade ≥ 3).
- For the endpoint ‘therapy discontinuation due to AEs’, there is a statistically significant difference in favour of atezolizumab between the treatment arms. However, this effect is subject to excessive uncertainty and is assessed as insufficient to infer any additional benefit with regard to side effects on this basis.
- Taking the available results on patient-relevant endpoints from the adjusted indirect comparison into account as a whole, no relevant improvement in treatment-related benefit can be identified.
b) Adults with metastatic non-small cell lung cancer (NSCLC) whose tumours exhibit PD-L1 expression in < 50% of tumour cells and PD-L1 expression of ≥ 10% in tumour-infiltrating immune cells, and who do not have EGFR mutations or ALK-positive NSCLC; first-line treatment
- The additional benefit is not proven.
- No data are available to enable an assessment of the additional benefit.
- In its dossier, the pharmaceutical manufacturer does not take patient population b) into account and, accordingly, does not provide any data for the assessment of additional benefit.
Courtesy translation only, please refer to the German original.
Associated procedures
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