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)
ICD-10 codes (AIS)
C54.1Malignant neoplasm of endometrium
Alpha-ID codes (AIS)
I27788Endometrial carcinoma
Therapeutic area
Oncological diseases
Endometrial cancer (EC)
Reason for procedure
New therapeutic indication
Specialty
Bundling
Therapeutic indication of the resolution
Keytruda is indicated in combination with carboplatin and paclitaxel for the first-line treatment of primary advanced or recurrent endometrial carcinoma in adults who are suitable for systemic therapy.
Subpopulation
Indication
Comparator
a)
Adult patients with primary advanced endometrial carcinoma (stage III or IV) or recurrent endometrial carcinoma with mismatch repair deficiency (dMMR) or high microsatellite instability (MSI-H) who have not yet received systemic therapy for the treatment of primary advanced disease.
– have not yet received systemic therapy as postoperative or adjuvant therapy for the treatment of primary advanced disease,
– have not yet received chemotherapy for the recurrence
Dostarlimab in combination with carboplatin and paclitaxel followed by Dostarlimab as monotherapy
b)
Adult patients with primary advanced endometrial carcinoma (stage III or IV) or recurrent endometrial carcinoma with mismatch repair failure (pMMR), who are to be treated with the drug. treatment
– have not yet received systemic therapy as postoperative or adjuvant therapy for the treatment of primary advanced disease,
– have not yet received chemotherapy for the recurrence
Durvalumab in combination with carboplatin and paclitaxel followed by durvalumab in combination with olaparib
Studies and Results
No. of studies
(best subpopulation)
0 (Data not accepted)
Study design
(best subpopulation)
Data not accepted
(Dossier: H2H vs. ACT)
Reason for dividing into subpopulations (G-BA)
Gene/mutation specifics
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.
