Endometrial carcinoma, first-line, combination with carboplatin and paclitaxel
Characteristics
Start date
15.11.2024
–
Marketing authorisation:
21.10.2024
Resolution
15.05.2025
INN
Pembrolizumab
Brand name
Keytruda®
Pharm. company
MSD Sharp & Dohme GmbH
G-BA Procedure ID
D-1129
ATC code
L01FF02
PD-1/PDL-1 inhibitors (L01FF)
Therapeutic area
Oncological diseases
Reason for procedure
New therapeutic indication
Specialty
Bundling
Studies and Results
Clinical trials
The KEYNOTE 868 trial is an ongoing, multicentre, double-blind, randomised controlled Phase IIItrial comparing pembrolizumab in combination with carboplatin and paclitaxel, followed by pembrolizumab, with placebo in combination with carboplatin and paclitaxel, followed by placebo.
a) Adult female patients with primary advanced endometrial carcinoma (stage III or IV) or recurrent endometrial carcinoma withmismatch repair deficiency (dMMR) or high microsatellite instability (MSI-H), who, for the treatment of − primary advanced disease, have not previously received any systemic therapy as postoperative or adjuvant therapy, − recurrence, have not yet received any chemotherapy
The additional benefit is not proven.
Consequently, the control arm of the study does not correspond to the appropriate comparator therapy in either of the two patient groups. Therefore, no suitable data are available.
In conclusion, it is established that for pembrolizumab in combination with carboplatin and paclitaxel, followed by pembrolizumab, as first-line treatment for primary advanced or recurrent endometrial cancer in adults who are suitable for systemic therapy, an additional benefit is not proven.
b) Adult female patients with primary advanced endometrial cancer (stage III or IV) or recurrent endometrial cancer withmismatch repair proficiency (pMMR), who, for the treatment − of their primary advanced disease, have not previously received any systemic therapy as postoperative or adjuvant therapy, − of their recurrence, have not yet received any chemotherapy
The additional benefit is not proven.
Consequently, the comparator arm of the study does not correspond to the appropriate comparator therapy in either of the two patient groups. Therefore, no suitable data are available.
The conclusion is that for pembrolizumab in combination with carboplatin and paclitaxel, followed by pembrolizumab, as first-line treatment for primary advanced or recurrent endometrial cancer in adults who are suitable for systemic therapy, an additional benefit is not proven.
Courtesy translation only, please refer to the German original.
