Pembrolizumab (5) – Keytruda®
Urothelial carcinoma (UC)
Characteristics
| Start date | 15.09.2017 – Marketing authorisation: 24.08.2017 |
|---|---|
| Resolution | 16.03.2018 repealed |
| INN | Pembrolizumab |
| Brand name | Keytruda® |
| Pharm. company | MSD SHARP & DOHME GMBH |
| G-BA Procedure ID | D-311 |
| ATC code | L01FF02 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 | 9.5 mg P |
| Therapeutic area | Oncological diseases Urothelial carcinoma (UC) |
| Reason for procedure |
New therapeutic indication
Repealed by: Pembrolizumab (7) (20.06.2019) |
| Therapeutic indication of the resolution |
|---|
|
KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy. KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy and whose tumours express PD-L1 with a combined positive score (CPS) ≥ 10. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| 1) | Treatment of locally advanced or metastatic urothelial carcinoma: patients not suitable for cisplatin-based therapy (first-line). | Chemotherapy as prescribed by the doctor |
| 2a) | Treatment of locally advanced or metastatic urothelial carcinoma: patients with previous platinum-based therapy with an early recurrence (≤ 6 months). | Vinflunine or repeated cisplatin-based chemotherapy (for patients who, depending on their disease progression, general condition and tolerability of first-line therapy, are eligible for such therapy) |
| 2b) | KEYTRUDA is indicated as monotherapy for the treatment of locally advanced or metastatic urothelial carcinoma after prior platinum-based therapy in adults | Vinflunine or repeated cisplatin-based chemotherapy (for patients who, depending on their disease progression, general condition and tolerability of first-line therapy, are eligible for such therapy) |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (KEYNOTE 045) |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. ACT |
|
Meta analysis
(best subpopulation) |
no |
| Reason for dividing into subpopulations (G-BA) | Previous treatment, Patient eligibility |
- Clinical trials
- KEYNOTE052 is a multicentre, non-randomised, open-label, single-arm, Phase II trial investigating the efficacy and safety of pembrolizumab in patients with advanced, unresectable or metastatic urothelial carcinoma.
1) Patients who are not suitable for cisplatin-based therapy (first-line)
- No additional benefit is proven for the first-line treatment of locally advanced or metastatic urothelial carcinoma in patients for whom cisplatin-based chemotherapy is not suitable.
- mortality
- In particular, the results regarding overall survival from the non--adjusted comparison – 11.0 months compared with 7.2 to 10 months under treatment with gemcitabine and carboplatin – are of such a magnitude that it cannot be ruled out with sufficient certainty that the difference is attributable solely to systematic bias.
- morbidity
- Results for the endpoint categories of morbidity and quality of life are entirely lacking.
- Health-related quality of life
- Results for the endpoint categories of morbidity and quality of life are entirely missing.
- Health-related quality of life was assessed using the functional scales of the EORTC QLQ-C30.
- Side effects
- Results regarding adverse events were reported only selectively and are therefore incomplete.
- Overall assessment
- Overall, in first-line treatment of patients who are not suitable for cisplatin-based therapy, the additional benefit of pembrolizumab 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.
2) 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
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