Atezolizumab (3) – Tecentriq®
Urothelial carcinoma (UC), PD-L1 expression ≥ 5%, first-line
Characteristics
| Start date | 01.01.2019 – Marketing authorisation: 02.07.2018 |
|---|---|
| Resolution | 20.06.2019 |
| Limitation date | 01.10.2021 limitation repealed |
| INN | Atezolizumab |
| Brand name | Tecentriq® |
| Pharm. company | Roche Pharma AG |
| G-BA Procedure ID | D-419 |
| ATC code | L01FF05 PD-1/PDL-1 inhibitors (L01FF) |
| ICD-10 codes (AIS) | C65Malignant neoplasm of renal pelvis, C66Malignant neoplasm of ureter, C67.0Malignant neoplasm of trigone of bladder, C67.1Malignant neoplasm of dome of bladder, C67.2Malignant neoplasm of lateral wall of bladder, C67.3Malignant neoplasm of anterior wall of bladder, C67.4Malignant neoplasm of posterior wall of bladder, C67.5Malignant neoplasm of internal urethral orifice, C67.6Malignant neoplasm of ureteric orifice, C67.7Malignant neoplasm of urachus, C67.8Malignant neoplasm of overlapping sites of bladder, C67.9Malignant neoplasm of bladder, unspecified, C68.0Malignant neoplasm of urethra, C68.8Primary malignant neoplasm of two or more contiguous sites of urinary organs whose point of origin cannot be determined, C68.9Malignant neoplasm of urinary system NOS |
| Alpha-ID codes (AIS) | I104386Malignant neoplasm of the urinary bladder sphincter, I13895Malignant neoplasm of the urinary bladder, I14845Malignant neoplasm of the neck of the bladder, I15288Malignant neoplasm of the posterior bladder wall, I15360Malignant neoplasm of the lateral bladder wall, I15411Malignant neoplasm of the anterior bladder wall, I20177Malignant neoplasm of the renal pelvis, I20685Malignant neoplasm of the ostium ureteris, I22423Malignant neoplasm of the trigonum vesicae, I22501Malignant neoplasm of the urachus, I22610Malignant neoplasm of the ureter, I22762Malignant neoplasm of the urethra, I22909Urothelial carcinoma, I30262Malignant neoplasm of the apex vesicae |
| DDD | 57 mg P |
| Therapeutic area | Oncological diseases Urothelial carcinoma (UC) |
| Reason for procedure |
Reassessment: §13 (G-BA request)
Original resolution: Atezolizumab (2) (16.03.2018) |
| Therapeutic indication of the resolution |
|---|
|
Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC): – after prior platinum-containing chemotherapy, or – who are considered cisplatin ineligible, and whose tumours have a PD-L1 expression ≥ 5% |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are not suitable for cisplatin-based therapy and whose tumours have PD-L1 expression ≥ 5 %; first-line | Chemotherapy as determined by the physician operationalised as combination therapy of carboplatin with gemcitabine |
Studies and Results
|
No. of studies
(best subpopulation) |
4 (Bellmunt 2001, Carles 2000, Linardou 2004, Bamias 2007) |
|---|---|
|
Study design
(best subpopulation) |
Single-arm + historical comparison |
|
Meta analysis
(best subpopulation) |
no |
a) Urothelial carcinoma; patients who are not suitable for treatment with cisplatin and whose tumours have PD-L1 expression ≥ 5 % (first-line)
- Additional benefit is not proven for the treatment of locally advanced or metastatic urothelial carcinoma in adult patients who are not suitable for treatment with cisplatin and whose tumours have PD-L1 expression of ≥ 5%.
- mortality
- The median overall survival in the single-arm IMvigor210 trial, based on the latest data cut-off (12 July 2017), is 16.3 months, which is marginally longer than the 7.2 to 10 months observed following treatment with gemcitabine and carboplatin, compared with the data available at the time of the initial assessment.
- In the context of the four head-to-head comparisons of overall survival conducted by the pharmaceutical manufacturer, only the results of two analyses are statistically significantly different for the current data cut-off as well.
- Side effects
- As previously described in the initial assessment, the data on adverse events are once again incomplete, as no comparative data are available for some adverse events.
- Overall assessment
- The data submitted by the pharmaceutical manufacturer are not suitable for establishing any additional benefit of atezolizumab compared with the appropriate comparator therapy.
- On the one hand, the data are incomplete, particularly with regard to adverse events. Due to this incomplete data set, no proper comparison can be made between atezolizumab and the appropriate comparator therapy.
- Furthermore, the effects reported are not sufficiently large to rule out the possibility that the differences are attributable solely to confounding factors.
- Statements regarding additional benefit based on a comparison of individual arms from different studies can, due to the high uncertainty of the results, only be made if very large effects are present. However, such effects are not present here for relevant endpoints relating to overall survival, symptoms, health-related quality of life and adverse events.
- In summary, there are therefore no suitable data available to establish the additional benefit of atezolizumab as monotherapy; this applies in particular to the patient population covered by the current marketing authorisation (patients with tumours exhibiting PD-L1 expression ≥ 5 %). Due to the limited data available, the additional benefit of atezolizumab as monotherapy is therefore not proven for patients who are unsuitable for treatment with cisplatin and whose tumours have PD-L1 expression ≥ 5%.
Courtesy translation only, please refer to the German original.
Associated procedures
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