Atezolizumab (2) – Tecentriq®
Urothelial carcinoma (UC), first-line
Characteristics
| Start date | 01.10.2017 – Marketing authorisation: 21.09.2017 |
|---|---|
| Resolution | 16.03.2018 repealed subpopulations |
| INN | Atezolizumab |
| Brand name | Tecentriq® |
| Pharm. company | Roche Pharma AG |
| G-BA Procedure ID | D-314 |
| 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 |
Initial assessment
Repealed by: Atezolizumab (3) (20.06.2019) |
| Specialty | Bundling ACT change Special practice conditions |
| 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 |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Urothelial carcinoma: patients not suitable for cisplatin-based therapy (first line) | Chemotherapy as prescribed by the doctor |
| b1) | Urothelial carcinoma: patients with previous platinum-based therapy with an early recurrence (≤ 6 months) / late relapse (> 6 - 12 months). | Vinflunin |
| b2) | Urothelial carcinoma: patients with previous platinum-based therapy with a late relapse (> 6 - 12 months). | Vinflunine or renewed cisplatin-based chemotherapy |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (Mvigor211) |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. ACT |
|
Meta analysis
(best subpopulation) |
no |
| Reason for dividing into subpopulations (G-BA) | Previous treatment, Patient eligibility |
| ACT change | 21.07.2017 – Zulassungänderung nach positiver Opinion (EMA) |
a) Patients who are not suitable for cisplatin-based therapy (first-line treatment)
- An additional benefit is not proven for the first-line treatment of locally advanced or metastatic urothelial carcinoma in patients for whom cisplatin-based chemotherapy is not suitable.
- mortality
- Results on overall survival are available from only four studies; the results for median overall survival in the single-arm IMvigor210 study, at 15.9 months, compared with results for treatment with gemcitabine and carboplatin ranging from 7.2 to 10 months, are not of a magnitude at which it can be ruled out with sufficient certainty that a difference is not attributable solely to systematic bias.
- Of the four individual comparisons of overall survival conducted by the pharmaceutical manufacturer, only the results of two analyses show a statistically significant difference.
- Side effects
- Adverse events were also reported for the benefit assessment dossier, both in terms of relevant overall rates and in terms of specific chemotherapy- and immunotherapy-associated events.
- Results on adverse events were reported only selectively or were not adequately operationalised and are therefore incomplete. For instance, the comparative studies included provide no data on the overall rates of adverse events (severe AE with CTCAE grade ≥ 3, SAE). Results on therapy discontinuations due to adverse events are available only from IMvigor210 and two comparative studies.
- With regard to specific AEs, in the absence of further data from the comparative studies, only those AEs that were recorded in at least one of the studies included in the comparison were compared. Inevitably, this comparison is therefore focused on chemotherapy-associated side effects, as all the studies included in the comparison investigated chemotherapy regimens.
- Overall assessment
- Overall, in first-line treatment of patients who are not suitable for cisplatin-based therapy, an additional benefit of atezolizumab is not proven due to the limited data available. There are no usable results available that could not have arisen solely as a result of systematic bias.
- For this reason, the information on specific AEs is not sufficient to provide a comprehensive overview of the harm associated with atezolizumab; consequently, individual significant advantages regarding specific AEs are, on the whole, insufficient to demonstrate an additional benefit of atezolizumab in first-line treatment for patients unsuitable for cisplatin-ineligible patients.
b) Patients who have previously received platinum-based therapy
- The pharmaceutical manufacturer does not present any results in the dossier from directly comparative studies or studies suitable for an adjusted indirect comparison for this population.
Courtesy translation only, please refer to the German original.
Associated procedures
<< List of all resolutions