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
KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy.
Subpopulation
Indication
Comparator
a)
Monotherapy indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not suitable for cisplatin-based therapy and whose tumours express PD-L1 with a combined positive score (CPS) ≥ 10.
Chemotherapy as prescribed by the doctor
Studies and Results
No. of studies
(best subpopulation)
1
(KEYNOTE-361)
Study design
(best subpopulation)
Single-arm + historical comparison
Meta analysis
(best subpopulation)
no
Clinical trials
KEYNOTE-052 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.
a) Urothelial carcinoma; patients who are unsuitable for cisplatin-based therapy and whose tumours express PD-L1 with a combined positive score (CPS) ≥ 10 (first-line)
An additional benefit is not proven for the treatment of locally advanced or metastatic urothelial carcinoma in adult patients who are not suitable for cisplatin-based therapy and whose tumours express PD-L1 with a combined positive score (CPS) ≥ 10.
Overall, for patients who are not suitable for cisplatin-based therapy and whose tumours express PD-L1 with a combined positive score (CPS) ≥ 10, the additional benefit of pembrolizumab as monotherapy is not proven due to the limited data available.
mortality
The median overall survival for the population under the restricted marketing authorisation from the KEYNOTE-052 trial is 18.5 months, compared with 7.2 to 10 months with treatment using gemcitabine and carboplatin.
Health-related quality of life
Health-related quality of life was assessed using the functional scales of the EORTC QLQ-C30.
Side effects
Results on adverse events were reported only selectively and are therefore incomplete.
Overall assessment
The data submitted by the pharmaceutical manufacturer are not sufficient to demonstrate any additional benefit of pembrolizumab over the appropriate comparator therapy.
On the one hand, the comparison of individual arms from different studies presented by the pharmaceutical manufacturer is based on incomplete data. This stems in particular from the fact that, in the comparative studies with carboplatin plus gemcitabine, there is very little data available on patient-relevant endpoints. Furthermore, the effects presented are not sufficiently large to rule out with sufficient certainty that the differences are due solely to bias.
Courtesy translation only, please refer to the German original.
